louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05921045: Learning Skills in Shoulder Dystocia Delivery Using Simulator Models
Official title: Shoulder Dystocia Delivery and Learning Skills on Mannequin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Dystocia - Delivered
Birth Disorder
Keywords: emergency delivery
Shoulder dystocia
mannequin
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: Claudio Crescini, MD Humanitas Milan Italy
name: Federico Prefumo, Istituto Giannina Gaslini
name: Claudio Meloni, University of Florence
First posted: 2023-06-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents specialists midwies

Brief summary: Learning skills on shoulder dystocia on doctor and midwife

Detailed description: Active learning on mannequin for shoulder dystocia deliveries on doctor and midwife using role play approach and its effect on clinical practice using questionnaires after first training and 6 months training

Eligibility criteria: Inclusion Criteria:

* residents and specialists in obstetrics and gynecology
* midwives

Exclusion Criteria:

* none

Primary outcomes:
measure: Management of SD
timeFrame: 6 months
Secondary outcomes:
measure: Clinical approach in labor ward in identification and management of SD (with previous SD)
timeFrame: 6 months
measure: Clinical approach in labor ward in identification and management of SD (without previous SD)
timeFrame: 6 months
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Claudio Celentano
state: Italia
Study officials:
affiliation: EASC
name: Claudio Celentano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223945: Thrombohemorrhagic Complications of COVID-19
Official title: Surgical and Anesthesiological-resuscitation Aspects of Therapeutic Tactics for Thrombotic and Hemorrhagic Complications in Patients With the New Coronavirus Infection COVID-19
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19 (Coronavirus Disease 2019)
Lead sponsor: Volgograd State Medical University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The nature of the planned study:

The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes.

It is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with COVID-19 during the pandemic (8 cities).

As a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with COVID-19.

The proposed study will be multicenter, cohort, retrospective.

The purpose of the study:

Improvement of treatment results in COVID-19 patients with thrombotic or hemorrhagic complications

Scientific novelty:

For the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with COVID-19.

For the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of COVID-19.


Eligibility criteria: Inclusion Criteria:

* Patients with thrombohemorrhagic complications who were treated in a covid hospital

Exclusion Criteria:

* Cancer patients
* Patients who had thrombohemorrhagic disorders before admission to the hospital
* Pregnant women
* Patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital

Primary outcomes:
measure: development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Volgograd
country: Russian Federation
facility: Clinic №1 of Volgograd State Medical University
Study officials:
affiliation: Volgograd State Medical University
name: Viktor Mikhin
role: STUDY_CHAIR
References:
Clinical trial NCT00016445: Phase II Study of Growth Hormone in Children With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
disease-related problem/condition
genetic diseases and dysmorphic syndromes
quality of life
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2001-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis.

II. Determine the effect of growth hormone on pulmonary function in these patients.

III. Determine the impact of this drug on the quality of life in these patients.

IV. Determine if the clinical response from this drug is sustained in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only.

Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.

Quality of life is assessed at baseline and then every 6 months for 2 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of prepubertal cystic fibrosis
* No colonization by Burkholderia cepacia

--Prior/Concurrent Therapy--

* No prior or concurrent insulin requirement

--Patient Characteristics--

* Hematopoietic: No hematologic disease
* Hepatic: No liver disease
* Renal: No kidney disease
* Pulmonary: Must be able to perform pulmonary function testing
* Other: No history of diabetes Must be less than 25% of normal height and/or weight for age and sex

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Indianapolis
country: United States
facility: James Whitcomb Riley Hospital for Children
state: Indiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Dayton
country: United States
facility: Children's Medical Center - Dayton
state: Ohio
city: Tulsa
country: United States
facility: T.L. Carey, M.D. and Associates
state: Oklahoma
city: Dallas
country: United States
facility: Southwest Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center - Fort Worth
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
Study officials:
affiliation: Southwest Medical Center at Dallas
name: Dana S. Hardin
role: STUDY_CHAIR
References:
Clinical trial NCT06754345: 68Ga-NK224 PET Imaging of PD-L1 Expression in Cancers
Official title: 68Ga-NK224 PET Imaging of PD-L1 Expression in Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumor
PD-L1
Keywords: Tumor
PD-L1
PET/CT
diagnosis
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-NK224 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 68Ga-NK224 positron emission tomography/computed tomography (PET/CT) for the evaluation of PD-L1 expression in primary and/or metastatic tumors, compared with histopathological results.

Detailed description: Participants with cancer underwent 68Ga-NK224 PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and mean SUV (SUVmean). In addition, the PD-L1 expression of lesions was confirmed by histopathological analyzing. The quantitative parameters of 68Ga-NK224 PET/CT were compared with histopathological result to evaluate the diagnostic efficacy.

Eligibility criteria: Inclusion Criteria:

* (i) adult patients (aged 18 years or order);
* (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
* (iii) patients who had scheduled 68Ga-NK224 PET/CT scans;
* (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions;
* (ii) patients with pregnancy;
* (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: The concordance between 68Ga-NK224 PET/CT and histopathological result in PD-L1 expression
timeFrame: 30 Days
Secondary outcomes:
measure: Evaluate the intra- and inter- tumor heterogeneity
timeFrame: 30 Days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References:
Clinical trial NCT02478645: Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 177
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
* patient scheduled for elective gynecological laparoscopic surgery.

Exclusion Criteria:

* hepatorenal disease
* BMI \> 35 kg/m2
* allergy to ramosetron
* gastrointestinal disease
* vomiting within 24h
* administration of antiemetics or opioids within 24h
* QT prolongation (QTc \> 440ms)
* pregnant
* problem with communication

Primary outcomes:
measure: postoperative nausea and vomiting
timeFrame: within 48h after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu
Study officials:
References:
Clinical trial NCT03327545: Latent Myofascial Trigger Points in the Craniocervical Region
Official title: Clinical Efficacy of Mobilization of the Nervous System Compared to Soft Tissue Techniques Intervention in Asymptomatic Subjects With Latent Myofascial Trigger Points in the Craniocervical Region: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Trigger points
Trigegeminal nerve
Pain
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 50
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: TREATMENT

Brief summary: Myofascial pain is a clinical problem that has generated interest, debate and confusion for decades. According to studies anywhere between 33 and 97 % of patients with musculoskeletal pain visiting physicians and manual therapists are diagnosed with Myofascial Trigger Points (MTrPs). MTrPs are localized, hyperirritable points that are associated with palpable nodules in taut bands (TB) of muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke spontaneous pain. The myofascial trigger points (MTrPs) are common in healthy subjects and in patients with musculoskeletal pain, and could produce sensitive disturbances and motor dysfunctions


Eligibility criteria: Inclusion Criteria:

* Neck pain

Exclusion Criteria:

* myelopathy
* fracture
* infection
* dystonia
* tumor
* inflammatory disease
* fibromyalgia
* or osteoporosis

Primary outcomes:
measure: Change from Pain intensity at 24 hours
timeFrame: 24 hours, 5 minutes after the treatment
measure: Maximum mouth opening without pain at 24 hours
timeFrame: 24 hours, 5 minutes after the treatment
Secondary outcomes:
measure: Pain Catastrophizing Scale (PCS) at 24 hours
timeFrame: 24 hours, 5 minutes after the treatment
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: JORGE H VILLAFAÑE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03150745: Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix
Official title: Office Hysteroscopy Versus Stationary Coloposcopy for Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cervical Dysplasia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endocervix (cervical canal) is the cavity of the cervix and connects the external os with the internal os. It is fusiform in shape and has posterior and anterior oblique longitudinal ridges, the plicae palmatae. These are not exactly apposed but inter-lock like a zipper so that the canal is kept closed.

The original squamous epithelium is clearly identified as a smooth, usually featureless covering of the cervix; its uniform pink color contrasts with the redness of the original columnar epithelium. It joins the latter at the original squamocolumnar junction.

Many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities. Such abnormalities as ectropion, Nabothian cysts, and small cervical polyps are quite benign and need not generate concern for patient or clinician, whereas others, including those associated with a history of exposure to diethylstilbestrol, cervical inflammation, abnormal cervical cytology, and postcoital bleeding, should prompt additional evaluation. Further, in some patients, the cervix may be difficult to visualize. Several useful clinical suggestions for the optimal examination of the cervix are presented.


Eligibility criteria: Inclusion Criteria:

1. Suspicious cervix
2. Age between 20 to 60 years

Exclusion Criteria:

1. Previously diagnosed cervical lesions.
2. Pregnant women.

Primary outcomes:
measure: The sensitivity of office hysteroscopy detection of cervical lesions
timeFrame: 1 week
measure: The sensitivity of colposcopy
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT00453245: Molecular Basis of the Growth Axis in Short Stature
Official title: Study of the Molecular Basis of the Growth Axis Among Short Stature Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-03-28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 81
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: To examine the clinical genetic and biochemical characteristics of children with growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* Patient with growth hormone deficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: Yardena T Rakover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06314945: Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula
Official title: Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula; Pre Versus Intraoperative Findings: a Comparative Cross Section Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perianal Fistula
Keywords: recto-perineal ultrasound
perianal fistula
trans-sphincteric
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-03-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: only patients with perianal fistula or abscess in zagazig university hospitals who admitted during the study duration were included in the study

Brief summary: Perianal fistula is a common anal problem. It needs only surgery. MRI is the best preoperative diagnostic tool, but it is demanding as it is expensive, time consuming and needs an experienced radiologist. So, we tried to find an alternative diagnostic tool which is cheaper, time saving and accurate and comparing its preoperative reports with intraoperative findings.

study was held in surgery department in Zagazig University Hospitals from September 2023 to March 2024. It included 93 patients with perianal fistula who were diagnosed clinically and radiological by trans recto-perineal ultrasound and comparing pre-operative ultrasound findings with intra-operative surgical findings.


Eligibility criteria: Inclusion Criteria:

* Perianal abscess and\\or fistula
* Patients who accidently discovered during transvaginal ultrasound.
* Age group between above 18 years old

Exclusion Criteria:

* Informed consent refusal.
* Proved anal malignancy.
* Patients less than 18 years old

Primary outcomes:
measure: age
timeFrame: from 2 to 3 days before operation
measure: sex
timeFrame: from 2 to 3 days before surgery
measure: body mass index
timeFrame: from 2 to 3 days before surgery
measure: history of abscess drainage
timeFrame: from 2 to 3 days before surgery
measure: Internal opening
timeFrame: from 2 to 3 days pre-operative and intraoperatively
measure: fistula branches
timeFrame: from 2 to 3 days pre-operative and intraoperatively
measure: type fistulous tract
timeFrame: from 2 to 3 days pre-operative and intraoperatively
measure: abscess cavity
timeFrame: from 2 to 3 days pre-operative and intraoperatively
Secondary outcomes:
measure: other anal disease
timeFrame: from 2 to 3 days before surgery
measure: external openings
timeFrame: from 2 to 3 days pre-operative and intraoperatively
measure: anal discharge
timeFrame: from 2 to 3 days before surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
affiliation: faculty of medicine Zagazig University
name: Reham Zakaria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06026345: Affera Global Registry
Official title: The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2023-09-07
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for an ablation with the Affera Platform may be approached regarding enrollment in this study.

Brief summary: The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned procedure using the commercially available Affera Platform
* Willing and able to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
* Subject with exclusion criteria required by local law

Primary outcomes:
measure: Primary Objective #1 (Efficacy)
timeFrame: 12 Month Post Proceedure
Secondary outcomes:
measure: Primary Objective #2 (Safety)
timeFrame: 90 Days Post Proceedure
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Praha 4
country: Czech Republic
facility: IKEM - Institut Klinické a Experimentální Medicíny
city: Praha 5
country: Czech Republic
facility: Nemocnice Na Homolce
city: Bordeaux
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Toulouse Cedex 3
country: France
facility: Clinique Pasteur
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte
city: Frankfurt
country: Germany
facility: MVZ CCB Frankfurt und Main Taunus GbR
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum
city: Dublin
country: Ireland
facility: Beacon Hospital
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
Study officials:
References: