louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06671418: Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Official title: Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Cholangiocarcinoma Non-resectable
Gall Bladder Cancer
Liver Metastasis
Malignant Hilar Stricture
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2024-11-04
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is:

To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection.

Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur.

Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be given according to ICH/GCP and national/local regulations.
* MHBO on imaging with histopathological confirmation or high clinical suspicion.
* Ineligible for surgical resection.
* Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l.

Exclusion Criteria:

* Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis.
* Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed.
* Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°C) and leucocytosis (i.e. ≥10 \*109/L) without clinical or radiological evidence of acute cholecystitis (22).
* Uncorrectable coagulation disorder.
* Uncorrectable contrast allergy.

Primary outcomes:
measure: Major complications within 90 days after randomisation
timeFrame: 90 days after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
References:
Clinical trial NCT04495218: NGS Panel of Incomplete Forms of Ocular Albinism
Official title: Implementation of a Next-generation Sequencing Analysis of a Panel of Genes Implicated in Incomplete Forms of Albinism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Albinism, Ocular
Keywords: Next generation sequencing
Albinism
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 53
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a clinical diagnosis of incomplete form of albinism with presence of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic nerves at the chiasm and having a specialized consultation in CHU de Bordeaux

Brief summary: Implementation of a next-generation sequencing panel of genes to identify deleterious variants in patients with incomplete forms of albinism.

Detailed description: Scientific context : Albinism is clinically characterised by cutaneous hypopigmentation and ophthalmologic features. These features common to all forms of albinism are foveal hypoplasia, misrouting of the optic nerves at the chiasm, retinal hypopigmentation, translucent irides and nystagmus. The molecular genetic lab at Bordeaux University Hospital is the national reference for the study of this disease. More than 1400 patients have been analyzed with a strategy including next-generation sequencing of the 19 known genes of albinism and array-CGH. Despite this thorough analysis, 25% of patients remain without molecular diagnosis. Our experience tells us that these patients often show an incomplete form of albinism with the presence of only few ophthalmologic signs. The molecular diagnosis is very challenging as the phenotype often overlaps with other ophthalmologic disorders.

Eligibility criteria: Inclusion Criteria:

* Minor and adult patient.
* Patient presenting a clinical diagnosis of incomplete form of albinism with presence of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic nerves at the chiasm.
* Registered for the social security system.
* Informed consent signed by patient or parent of a minor patient.

Exclusion Criteria:

* Refusal to participate in research protocol.

Primary outcomes:
measure: Percentage of patients for whom a molecular diagnosis is obtained based on the panel of targeted genes
timeFrame: Enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
References:
Clinical trial NCT01652118: Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis
Official title: Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bronchopulmonary Dysplasia
Keywords: bronchopulmonary dysplasia
clarithromycin
preterm babies
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.

Detailed description: The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.

The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.

Eligibility criteria: Inclusion Criteria:

* all infant must be under 1250 gram birth weight

Exclusion Criteria:

* Major congenital anomaly,
* CardiaC abnormality,
* without inform consent

Primary outcomes:
measure: Bronchopulmonary dysplasia
timeFrame: 28. day of birth
Secondary outcomes:
measure: Overall survival
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
state: Middle Anatolia
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Ugur Dilmen, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00861718: Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
Official title: A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Healthy Volunteer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Multiple Ascending Dose Study


Eligibility criteria: Inclusion Criteria:

* Provision of Informed Consent
* Healthy male subjects and female subjects (of non-child bearing potential)

  * with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* Inability to understand or cooperate with given information
* Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
* History of seizure (including infancy febrile seizures) or family history of seizure

Primary outcomes:
measure: To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential.
timeFrame: Safety assessments are made at each visit, at least daily, during the study.
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD7268 in plasma.
timeFrame: Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, US
name: Sylvan Hurewitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06532318: Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment
Official title: Comparative Study Between Intralesional Injection of Platelet Rich Plasma and Intralesional Steroid for the Treatment of Trigger Finger in Black Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Trigger Finger Disorder
Lead sponsor: Obafemi Awolowo University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:

Does platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.

Participants will:

Take platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission


Eligibility criteria: Inclusion Criteria:

* Patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product.

No previous treatment for the affected finger.

Exclusion Criteria:

* Previous steroid injection
* Previous Surgery to that finger
* Thrombocytopenic patients
* Hand and finger contracture
* Rheumatoid arthritis of the finger

Primary outcomes:
measure: symptom resolution post injection
timeFrame: 3 months
Secondary outcomes:
measure: Hand grip strength
timeFrame: 3 month
measure: Q- DASH score
timeFrame: 3month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01719718: The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
Official title: The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Keywords: ventral hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.


Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient or his/her legal representative
* Ventral or incisional hernia requiring elective surgical repair
* Diameter between 2 and 5cm in width
* Midline and flank hernias are eligible

Exclusion Criteria:

* No written informed consent
* 'Hostile' abdomen, open abdomen treatment
* Contraindication to pneumoperitoneum
* Emergency surgery (incarcerated hernia)
* Parastomal hernia
* Subxiphoidal hernia
* Subcostal hernia
* Suprapubic hernia
* Clean-contaminated or contaminated field
* Hernia diameter \>5cm in width
* Pregnancy
* Non-compliance

Primary outcomes:
measure: Seroma formation after 4 weeks.
timeFrame: 4 weeks after surgery.
Secondary outcomes:
measure: Pain, discomfort and esthetic evaluation after 4 weeks.
timeFrame: 4 weeks after surgery.
measure: Pain, discomfort and esthetic evaluation after 1 year.
timeFrame: 1 year after surgery.
measure: Pain, discomfort and esthetic evaluation after 2 years.
timeFrame: 2 years after surgery.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Deinze
country: Belgium
facility: St Vincentius Hospital
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ghent
country: Belgium
facility: Maria Middelares
city: Namur
country: Belgium
facility: Hôpital Mont Godinne
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD, PhD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02923518: Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Official title: Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes) Who Participate in Long Distance Endurance Training and Competitions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Keywords: Heart Screening
Master Athletes
Cardiovascular Disease
Lead sponsor: LHL Helse
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 86
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Senior men and women \< 35 yrs participating in long-enurance competitions. 40 persons in a group with positive score and one group without.

Brief summary: In 2010 there was published new European recommendations for assessment of adult and elderly men and women, who want to start with physical activity and/or participate in endurance contests. In this study we want to test if a group of people with positive score on a self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have more undetected heart diseases than a control group with no reported or detected risk factors.

Detailed description: Forty senior athletes between 35 to approximately 80 yrs old with a positive score will be included in one group, and another forty seniors without positive score in a control group. Each of them will be tested with an cardiorespiratory exercise test (CPET) with ECG and examined with echocardiography together with an usual medical examination and blood tests (cholesterol and HbA1c-glucose). Some with symptoms of arrhythmias will be examined by 24-hours Holter-monitoring.

The main purpose of the study is to assess if men and women with a positive score on the questionnaire og NORRISK-screening (risk calculator for coronary heart disease) have more detectable heart diseases than the control group.

Eligibility criteria: Inclusion Criteria:

\> 35 yrs old Master athletes Positive score on symptom based questionnaire or high risk score No known heart disease Participated in long-term endurance competitions

Exclusion Criteria:

\< 35 yrs old Known heart disease

Primary outcomes:
measure: Differences among two groups of senior athletes in detecting heart diseases by a screening program
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Feiring
country: Norway
facility: LHL-clinics Feiring
Study officials:
affiliation: General manager the LHL-clinics
name: Hege Lundring, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01866618: Natural Cycle In Vitro Fertilization
Official title: Natural Cycle In Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Natural Cycle in Vitro Fertilization (IVF)
Keywords: Natural
IVF Cycle
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 524
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile patients

Brief summary: Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron \& hCG. Patients will not be given any other stimulating medications during the cycle. They will have 2 uterine aspirations and an endometrial biopsy at designated times. The first uterine aspiration will be randomized to one of four days (day before retrieval, day of retrieval, day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.


Eligibility criteria: Inclusion Criteria:

* Ovulatory cycles every 39 days or less (natural cycle IVF cannot be performed in someone who does not have cycles)
* Must be RMANJ patient and have completed all diagnostic screening at one of our RMANJ locations. All diagnostic screening is NOT covered under the study and must be completed prior to being allowed to start the study cycle.

Exclusion Criteria:

* Prior enrollment/attempt in this study
* Requirement for surgical sperm extraction
* Inability to assess ovaries via transvaginal ultrasound
* Inability to tolerate vaginal examination

Primary outcomes:
measure: Endometrial Changes
timeFrame: 1 Year
Secondary outcomes:
measure: Aneuploidy Rates
timeFrame: 1 Year
Other outcomes:
measure: Temporal Embryonic Development
timeFrame: 1 Year
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, M.D., HCLD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong KH, Franasiak JM, Werner MM, Patounakis G, Juneau CR, Forman EJ, Scott RT Jr. Embryonic aneuploidy rates are equivalent in natural cycles and gonadotropin-stimulated cycles. Fertil Steril. 2019 Oct;112(4):670-676. doi: 10.1016/j.fertnstert.2019.05.039.
Clinical trial NCT03986918: Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
Official title: Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Joint Diseases
Osteoarthritis, Hip
Rheumatoid Arthritis
Psoriatic Arthritis
Avascular Necrosis of Hip
Lead sponsor: Ortho Development Corporation
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
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: Identification will occur from a list of patients having undergone total hip arthroplasty at Straub Medical Center between 2012 and the end of December 2015. Identified patients will then be screened for eligibility criteria

Brief summary: The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.

Detailed description: Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries.

This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is five years post total hip arthroplasty
* Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
* Patient agrees to participate in the survey.

Exclusion Criteria:

* Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components

Primary outcomes:
measure: Survivorship - The number of revision surgeries over time.
timeFrame: 5 - 10-year follow-up
Secondary outcomes:
measure: Pain and Function
timeFrame: 5 - 10 year follow-up
measure: General Health
timeFrame: 5 - 10 year follow-up
measure: Patient satisfaction.
timeFrame: 5 - 10 year follow-up
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Straub Medical Center
state: Hawaii
Study officials:
affiliation: Hawai'i Pacific Health
name: Cass Nakasone, MD
role: PRINCIPAL_INVESTIGATOR
References: