louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05399563: Medico-legal Assessment of Sexual Violence-Assiut University
Official title: Medico-legal Assessment of Sexual Violence and Pregnancy Related Allegations Among Females Presented to Women's Health Hospital -Assiut University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attempted Rape of Female
Keywords: Obtain a detailed history and examination
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As nature of a descriptive study design; All eligible cases of substance abuse admitted to Women Health Hospital and Safe Women's Unit belong to Assiut will be examined for inclusion and exclusion criteria. The cases will be included in the study in duration of one year (March 2022- February 2023).

Brief summary: * Medico legal assessment of sexual assaults allegations of females presented to hospital and any associated violence.
* Assessment of cases of pregnancy associated violence with other related complications that have both medical and legal implications.
* Knowing role of VAW Unit in compacting female abuse offering support and authentication of suspicious claims

Detailed description: The data will be obtained after informed consents from cases. These cases will be then analyzed in terms of:

* Verifying legal procedures as careful reviewing of public prosecution order and associated victim's identification documents if present
* Obtain a detailed history including personal information as age, marital status' residence and education; incident circumstances like assault characteristics as numbers of assailants, relationship to the victim' place of assault' frequency of assault and the time lapse between examination and last assault, etc ; gynecologic and obstetric history.
* General examination that include proper documentation of all visible injuries all over the body (type' direction' location' shape) and local examination of genital or anal region and possibility of taking vaginal and anal swabs if possible.
* Re-examined victim after two weeks for exclude any venereal diseases and doing pregnancy test.

Eligibility criteria: Inclusion Criteria:

* All females above ≥ 12 years old with suspicious sexual violence or illegal pregnancy or criminal induction of abortion.

Exclusion Criteria:

* All females who will present to the women's health hospital above 12 years old for ordinary medical advice or treatment of gynecologic or obstetric complaints

Primary outcomes:
measure: Measure the prevalence of sexual violence problem among females
timeFrame: from 1-6-2022 to 28-5-2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05181163: Biofilm Formation and Antibiotic Sensitivity Patterns
Official title: In Vitro Biofilm Formation and Antibiotic Susceptibility Patterns of Bacteria From Surgical Site Infection After Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthopedic Surgery
Keywords: biofilm antibiotics
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients presenting in outpatient clinic or at operating theatre with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,...)

Brief summary: Detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery.

Detailed description: The available number of patients presenting in outpatient clinic or at operating theatre with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,...) will be subjected to full history and examined by physician. Swabs from site of infection will be taken and subjected to the following steps to identify the causative bacteria:

* Culturing on blood agar, chocolate agar, MacConkey agar and Mannitol salt agar , gram staining and biochemical tests.
* Enzyme-linked immunosorbent assay (ELISA) to detect biofilm formation.
* Antimicrobial Susceptibility Testing using the Kirby-Bauer disk diffusion method.

Eligibility criteria: Inclusion Criteria:

* patients with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,...)

Exclusion Criteria:

* if patient has no orthopedic surgery

Primary outcomes:
measure: detect biofilm formation
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: principal investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00970463: Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly
Official title: Impact of Growth Hormone on Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) and on Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Cardiac Function
Keywords: The GH-system and cardiac function
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with GHD based on an insufficient stimulation of GH-secretion during Pyridostigmin-GHRH test.

Patients with acromegaly based on an insufficient supression of GH-secretion during oral glucose tolerance test

Brief summary: To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and after treatment.

Detailed description: It is an open prospective noninterventional clinical study. Treatment and follow-up will be according to usual guidelines, and will be unaffected by inclusion in the study. GHD patients will be treated with daily subcutaneous GH injections. Patients with acromegaly will be treated with either transsphenoidal surgery or by medical treatment with long acting somatostatin analogues, dopamine agonist, GH antagonist or combinations of these treatment modalities.

Patients will be examined by Cardiac MRI before treatment and after one year of treatment.

Eligibility criteria: Inclusion Criteria:

* Peak GH below 6.0 ng/mL during Pyridostigmine-GHRH test.
* Nadir GH above 0.4 ng/mL and elevated levels of IGF-I during oral glucose tolerance test

Exclusion Criteria:

* Contraindications for magnetic resonance scan

Primary outcomes:
measure: Changes in cardiac function i relation to changes in the activity of the GH-axis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Andreassen M, Faber J, Kjaer A, Petersen CL, Kristensen LO. Cardiac function in growth hormone deficient patients before and after 1 year with replacement therapy: a magnetic resonance imaging study. Pituitary. 2011 Mar;14(1):1-10. doi: 10.1007/s11102-010-0250-7.
Clinical trial NCT01863563: Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy
Official title: Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: tonsillectomy
adenoidectomy
obstructive sleep apnea
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quickclot
Primary purpose: TREATMENT

Brief summary: Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.

Detailed description: The Quickclot dressing contains Kaolin, a natural mineral that promotes the body's clotting process. This dressing will be applied for one minute to the area where the tonsils/adenoids were. The investigators are hoping to develop a standard of practice where Quickclot is a key addition for tonsillectomy surgery.

Eligibility criteria: Inclusion Criteria:

* diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders

Exclusion Criteria:

* Patients with signs or symptoms of obstructed breathing
* recurrent pharyngitis
* history of bleeding disorder
* history of prior adenotonsillectomy

Primary outcomes:
measure: Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
timeFrame: at the time of surgery, 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Children's Hospital of the Kings Daughters
state: Virginia
Study officials:
affiliation: EVMS Department of Otolaryngology
name: Craig Derkay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01526863: Hydrolyzed Egg and Tolerance Induction
Official title: Assessment of the Effect of an HA Egg Administration for 6 Months on the Tolerance Induction to Egg in Children Allergic to Egg as Compared to a Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: Allergy
Egg
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral tolerance induction to egg in children allergic to egg as compared to a placebo.


Eligibility criteria: Inclusion Criteria:

* Child of any ethnicity aged between 12 and 66 months at the time of enrolment

  * Positive Skin Prick Test (SPT) to egg white within the last 3 months
  * Either positive oral challenge OR convincing history, defined as an immediate (\<1h) reaction following isolated ingestion of egg, positive SPT to egg white and positive sIgE (\> 0.35 kU/L) for at least one of the following: egg, egg white, ovalbumin, ovomucoid, within the last 12 months
  * Having obtained his/her signed legal representative's informed consent.

Exclusion Criteria:

* History of severe anaphylaxis to egg

  * Significant pre-natal and/or post-natal disease
  * Child on systemic drugs (e.g. antihistamines, beta-agonists, ACE-inhibitors) according to half-life at time of enrolment
  * Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
  * Child whose parents / caregivers cannot be expected to comply with treatment
  * Child currently participating in another interventional clinical trial

Primary outcomes:
measure: positive or negative result (objective and subjective symptoms) of a challenge test with egg
timeFrame: 6 months
Secondary outcomes:
measure: compliance (product taken)
timeFrame: 6 months
measure: skin prick test (sensitization to egg; size of wheal and flare)
timeFrame: 6 months
measure: Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation
timeFrame: 6 months
measure: Morbidity / Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University of Athens
city: Padua
country: Italy
facility: University Hospital of Padua
city: Davos Wolfgang
country: Switzerland
facility: Hochgebirgsklinik Davos
Study officials:
affiliation: University of Athens, Greece
name: Nikolaos Papadopoulos, Prof.
role: STUDY_CHAIR
affiliation: University Hospital of Padua, Italy
name: Antonella Muraro, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hochgebirgsklinik Davos, Switzerland
name: Roger Lauener, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Athens, Greece
name: Stavroula Giavi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01093963: Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression
Official title: Adjunctive Lisdexamfetamine in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar Depression
Lead sponsor: Lindner Center of HOPE
Sponsor class: OTHER
Collaborators: name: Shire
name: University of Cincinnati
First posted: 2010-03-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* Men and women, through the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
* Subjects who are displaying clinically significant homicidality or suicidality
* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.

Primary outcomes:
measure: Change in the Montgomery-Asberg Depression Rating Scale
timeFrame: 30-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Lindner Center of HOP
state: Ohio
Study officials:
References:
citation: McElroy SL, Martens BE, Mori N, Blom TJ, Casuto LS, Hawkins JM, Keck PE Jr. Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jan;30(1):6-13. doi: 10.1097/YIC.0000000000000051.
Clinical trial NCT01019863: Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
Official title: Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Hodgkin Lymphoma
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy, tolerance, quality of life and cost effectiveness of the association of Oxaliplatin, Gemcitabine, Rituximab and Dexamethasone for treatment of patients with refractory or relapsing non-Hodgkin lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years or above at the time of inclusion.
2. Documented CD20+ NHL, refractory or relapsing after first line chemotherapy.
3. No contraindication to Oxaliplatin, Gemcitabine, Dexamethasone or Rituximab.

Exclusion Criteria:

1. Other types of non-Hodgkin lymphoma
2. Pregnancy and lactation.
3. Patient unable to give written informed consent.
4. Contra-indication ou intolerance to any of the components of the RGDOx chemotherapy.

Primary outcomes:
measure: Response rate to RGDOx in patients with relapsing or refractory NHL
timeFrame: Within 3 months after chemotherapy (6-8 cycles)
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHA Hôpital de l'Enfant-Jésus
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Hopital Fleurimont
state: Quebec
Study officials:
affiliation: CHUS Hopital Fleurimont
name: Rami Kotb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06980935: STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications
Official title: Individualized 130 Hz Subthalamic Temporal Interference Stimulation Versus Medication for Motor Symptoms in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Keywords: subthalamic nucleus
transcranial temporal interference stimulation
MDS-UPDRS-Ⅲ
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the immediate effects of individualized 130 Hz STN-tTIS(Subthalamic Nucleus - transcranial Temporal Interference Stimulation)on motor symptoms in early-to-mid-stage PD patients during both medication "on" and "off" states. The main questions it aims to answer are:

1. Does the therapeutic effect of STN - tTIS relate to medication?
2. The degree of improvement in motor symptoms of Parkinson's disease patients after STN - tTIS therapy under different medication conditions.

Researchers compared the MDS - UPDRS - III improvement scores of tTIS therapy in the "on" and "off" medication phases to see if tTIS could work of independently medication.

1. Visit the clinic once every 1 weeks for therapy and test.
2. Record their symptoms and scores.

Detailed description: This clinical trial aims to explore whether individualized 130 Hz subthalamic tTIS can improve motor symptoms of PD independently of medication. . Each participant underwent two separate 20-minute sessions of individualized 130 Hz STN-tTIS: one during medication "on" (defined as stable dopaminergic medication effect) and one during medication "off" (after ≥12 hours withdrawal of dopaminergic medications). The order of sessions was randomized with at least 7 days washout between sessions to avoid carryover effects. And MDS - UPDRS - III scales are assessed before and after each treatment.

Eligibility criteria: Inclusion Criteria:

* MDS diagnosis of primary Parkinson's disease
* Hoehn \& Yahr stage \< 3
* Antiparkinsonian drugs remained unchanged in the past four weeks and dosage remained unchanged during the study

Exclusion Criteria:

* Presence of neurological disorders that may affect the study (e.g., Traumatic brain injury)
* History of antipsychotics, antidepressants, or dopamine modulators other than PD drugs
* Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers)
* Unstable vital signs

Primary outcomes:
measure: MDS-UPDRS-Ⅲ scores
timeFrame: pre-intervention, immediately after the intervention
Secondary outcomes:
measure: MDS-UPDRS-Ⅲ sub-scores
timeFrame: pre-intervention, immediately after the intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06866535: VIP - Vascular Infection Project
Official title: VIP - Vascular Infection Project : Prospective Multicentric Database on Vascular Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortitis
Vascular Graft Infection
Blood Vessel Prosthesis
Infections
Keywords: vascular graft and endograft infections
infectious aortitis
infectious arteritis
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 1000
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: ents with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent)

Brief summary: Constitution of a prospective multicentric observational database to study vascular infections, both native, especially aortitis, and vascular graft and endograft infections. Clinical and paraclinical data on medical, surgical, anesthetic and intensive care management will be collected in order to better characterize these infections

Detailed description: Vascular infections are rare but severe, burdened by high morbi-mortality and recurrence rates. However, many questions remain regarding their management which is still not consensual, both surgical and medical management. The term "vascular infections" encompasses vascular graft and endograft infections, as well as infections of native arteries and the aorta. For vascular graft infections, the optimal surgery is to remove the infected graft before vascular reconstruction with a new graft, either synthetic or biologic. However, some patients are too fragile to undergo surgery and might then benefit from an endovascular graft, an abscess drainage or no surgery at all, only medical treatment. For native arterial infections, surgery is often required to remove the infected arterial wall before vascular reconstruction. However, some patients cannot be operated on and might also benefit from an endovascular surgery. In these two vascular infections, the ideal anti-microbial treatment is uncertain, whether it pertains to the duration of therapy, the type of molecules, or their number. All of these medical and surgical factors may impact the prognosis of patients and should be collectively assessed in order to determine the best strategy for enhancing their outcomes.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years-old;
* all patients with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent),
* oral consent

Exclusion Criteria:

* patient under legal protection

Primary outcomes:
measure: mortality
timeFrame: Year 1
Secondary outcomes:
measure: mortality
timeFrame: Day 30, Year 2, Year 5
measure: morbidity
timeFrame: Year 1
measure: relapse
timeFrame: year 1, Year 2, Year 5
measure: reinfection
timeFrame: year 1, Year 2, Year 5
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: