louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06330324: Reproductive Options in Inherited Skin Diseases
Official title: Reproductive Options in Inherited Skin Diseases: an International Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ichthyosis
Palmoplantar Keratoses
Epidermolysis Bullosa
Ectodermal Dysplasia
Basal Cell Nevus Syndrome
Birt-Hogg-Dube Syndrome
Tuberous Sclerosis
Xeroderma Pigmentosum
Cutis Laxa
Albinism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 650
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: The study population consists of couples or adult inidividuals with genodermatosis keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) and a desire to have children, where PND and/or PGT were considered and/or performed.

Brief summary: The goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. By providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children.

To achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the Netherlands) and also an international level from various countries in Europe.


Eligibility criteria: Inclusion Criteria:

* Couples affected with molecularly confirmed genodermatosis (i.e., keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses)
* Prenatal diagnosis (PND) was performed and/or in vitro fertilisation (IVF) with pre-implantation genetic testing was performed (PGT).

Exclusion Criteria:

* No exclusion criteria were formulated.

Primary outcomes:
measure: Assessment of clinical outcomes of reproductive options
timeFrame: 2-3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Antoni Gostynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03567824: MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
Official title: A Phase 2 Open Label Study of Magnesium L-Lactate Dihydrate (MLD10) 10 mEq Extended-Release Caplets Administered BID for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus Followed by a Blinded Random Off Phase
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hypomagnesemia in Type 2 Diabetic Patients
Lead sponsor: Pharmalyte Solutions LLC
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will be treated open label for the first 3 months on study, then randomized to receive either active or placebo for an additional 3 months.
Primary purpose: TREATMENT

Brief summary: To determine the effect of MLD10 (magnesium L-lactate dihydrate extended-release caplets) 10 mEq BID on serum magnesium in Type 2 diabetic patients with hypomagnesemia.


Eligibility criteria: Inclusion Criteria:

* Females and males with Type 2 diabetes mellitus
* Body Mass Index between 18 to 40 kg/m2, inclusive, at Screening
* Hypomagnesemia defined as serum magnesium ≤ 1.5 mg/dL at Screening
* Females must be non-pregnant, non-lactating, and have a negative serum pregnancy test before enrollment.

Exclusion Criteria:

* History of clinically significant GI, renal, hepatic, neurologic, hematologic, endocrine other than Type 2 diabetes mellitus, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.

Primary outcomes:
measure: Change in Serum Magnesium Concentration
timeFrame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Secondary outcomes:
measure: Change in Serum Magnesium Concentration.
timeFrame: At 1 and 2 months after the initiation of treatment.
measure: Change in Fasting Blood Glucose
timeFrame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
measure: Change in Insulin Sensitivity
timeFrame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
measure: Change in Insulin Resistance
timeFrame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
measure: Change in HbA1c
timeFrame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05642624: The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock
Official title: The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection
Keywords: Blood Concentration
Deoxycholic Acid Amphotericin B
Fungal Infection
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 20
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: PROBABILITY_SAMPLE
Study population: Patients with Sepsis admitted to ICU of Zhongda hospital

Brief summary: To explore the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis/septic shock;To compare the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis and septic shock.

Detailed description: This was a single-center study.Patients who were diagnosed with in invasive fungal infection receieved deoxycholic acid amphotericin B during the study period.The information was recored including the general condition, infection index, PK/PD index and drug-related side effects.

Eligibility criteria: Inclusion Criteria:

Patients age more than 18 years old; Meet the criteria of Sepsis 3.0; Admitted to ICU; Patients were suspected or diagnosis of IFI,doctors determined the use of deoxycholic acid amphotericin B.

Exclusion Criteria:

Serum creatinine≥221umol/L; Deoxycholic acid amphotericin B or amphotericin B liposome were used for the past 7 days; Patients being treated with rifampicin; Unable to tolerate treatment of deoxycholic acid amphotericin B; BMI\<18.5 or \>30; Tumors; Pregnancy; Estimated time of survival\<24h; Patients who participated in other studies within 30 days.

Primary outcomes:
measure: Cmax/MIC
timeFrame: 14 days
Secondary outcomes:
measure: AUC24h/MIC
timeFrame: 14 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Huang Yingzi, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04202224: Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions
Official title: Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-emptive Analgesia in Different Psycho-emotional Status Patients
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. Previous studies evaluated effectiveness of pre-emptive analgesia but no relation to psycho-emotional status was addressed. Our authors believe that the effect of pre-emptive analgesia may vary based on different psycho-emotional status.

45 volunteers who needed extraction of lower third molars were examined and enrolled in the study (study group - 15; placebo - 15; control - 15 volunteers). Ibuprofen 400mg together with 500mg paracetamol was used for pre-emptive analgesia. Difficulty of the operation, heart rate measurements and operation protocol were documented. Surgeon filled his questionnaire after the procedure. Patients on consultation, operation day and 10 days postop. filled a questionnaire which consisted of general, special and pain evaluation sections. Less favorable psycho-emotional status correlated with more severe pain 6h after operation. This relation was mostly expressed in the control group. Psycho-emotional status of placebo patients was accounted for bigger analgesic consumption frequency. Postoperative pain in study group was minimal compared to other groups. Pre-emptive analgesia enhances patient's psycho-emotional status and sustains postoperative pain control during lower third molar surgical extractions.


Eligibility criteria: Inclusion Criteria:

* Adult patients;
* Indications for mandibular third molar removal.

Exclusion Criteria:

* Presence of NSAID usage;
* Acute inflammation in operating site;
* General diseases that might negatively influence the outcomes of operation, such as epilepsy, unstable neurological condition;
* Anticoagulant usage;
* Diabetes mellitus;
* Cardiovascular diseases.

Primary outcomes:
measure: Pre-emptive analgesia is effective in a negative psycho-emotional status patients
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian university of health sciences
Study officials:
References:
Clinical trial NCT01369524: Effect of Fluid Resuscitation and Microcirculation
Official title: Evaluation of Effect of Fluid Resuscitation on Sublingual Microcirculation by SDF Imaging in Intensive Care Patients, a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Fluid Volume Increased
Keywords: fluid responsiveness
microcirculation
Intensive Care
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted on the ICU and a need of fluids

Brief summary: Although the investigators take many measurements to monitor the fluid state of the patients, it is not known exactly whether the fluid has real effect on the organ perfusion. The main focus of fluid is to improve the organ perfusion. Recent research has focused on the investigation of sublingual microcirculatory alterations.

Detailed description: Is fluid responsiveness, what means a better cardiac output, equal to the need for fluid for a better organ perfusion? In hospital the investigators are now looking to the pump function of the heart, as there is not a better measurement. However this gives no information about necessity of giving fluids. A healthy volunteer also gives a better pump function of the heart after fluid, but that fluid is not necessary and gives no better organ perfusion. The question is: How many percent of the patients have a MFI score of \< 2.6, when the doctor on clinical basis plans to give fluid to the patient, improves organ perfusion after fluid, and is this correlated with an improvement of the cardiac output All intensive care patients who need extra fluid are eligible for this study. Before and after the fluid challenge we do SDF imaging sublingual. Per patient the investigators do this 1x in 24 hours. Concurrently, data on both patient characteristics (e.g. severity of illness) will be obtained Study population max 100 patients. Possible outcome: MFI \< 2,6 en SV \> 10% + MFI up MFI \< 2,6 en SV equal + MFI equal MFI \< 2,6 en SV \> 10% + MFI equal MFI \< 2,6 en SV equal + MFI up MFI \> 2,6 en SV \> 10% + MFI up MFI \> 2,6 en SV equal + MFI equal MFI \> 2,6 en SV \> 10% + MFI equal MFI \> 2,6 en SV equal + MFI up

Eligibility criteria: Inclusion Criteria:

* age \> 18
* hemodynamic monitoring
* informed consent
* admission on ICU

Exclusion Criteria:

* no informed consent
* oral surgery

Primary outcomes:
measure: correlation between change in microvascular flow index and fluid responsiveness - delta MFI before and after fluid challenge correlated to fluid responsiveness
timeFrame: 24 hours
Secondary outcomes:
measure: change in capillary density correlated to fluid responsiveness
timeFrame: 24 hours
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
affiliation: Frisius Medisch Centrum
name: Christiaan Boerma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02926924: Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients
Official title: Prophylactic Application of an Incisional Wound Vac to Prevent Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Wounds Vac
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI\>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications.

The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.


Eligibility criteria: Inclusion Criteria:

* Be scheduled to have posterior spine surgery (inpatient procedures only).
* Have a BMI greater than or equal to 35.

Exclusion Criteria:

* BMI less than 35
* Previous spine infection
* Intraoperative dural tear

Primary outcomes:
measure: Count of Patients With Post Operative Infection
timeFrame: 6 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rakesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04044924: Geriatric Head Trauma Short Term Outcomes Project
Official title: Geriatric Head Trauma Short Term Outcomes Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head Injury
Anticoagulant-induced Bleeding
Fall
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 5387
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Delray Medical Center and St. Mary's Medical Center emergency departments will be the major focal points for the study. These medical centers are located in Palm Beach County, Florida. Florida has the highest percentage of geriatric patients in the United States and, in particular, Palm Beach County has over 250,000 residents over the age of 65.

Brief summary: This prospective observational study will examine the incidence of intracranial hemorrhage. The investigators will compare patients on anticoagulant and/or antiplatelet therapy with head trauma compared to patients not on these medications. While many studies have sought to quantify the incidence of intracranial hemorrhage in these patients, there is considerable controversy regarding their care and what to do after an initial negative head CT in anticoagulated geriatric patients who have experienced head trauma.


Eligibility criteria: Inclusion Criteria: Patients seen in the emergency department for head trauma

Exclusion Criteria: Penetrating head trauma

Primary outcomes:
measure: Number of Participants with 14 Day ED Returns
timeFrame: 14 days
measure: Number of Participants with Primary Intracranial Hemorrhage
timeFrame: initial hospital visit
measure: Number of Participants with Delayed Intracranial Hemorrhage
timeFrame: 14 days
measure: Number of Participants with Hospitalizations at 14 days
timeFrame: 14 days
measure: Mortality of Participants
timeFrame: 60 days
Secondary outcomes:
measure: New Symptoms
timeFrame: 60 days
measure: Life alterations
timeFrame: 60 days
measure: New interventions since fall
timeFrame: 60 days
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
Study officials:
affiliation: Florida Atlantic University
name: Richard Shih, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03465124: Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery
Official title: Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery - FLAME
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age Related Cataracts
Cystoid Macular Edema
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bilateral cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either Femtosecond Laser assisted Cataract Surgery (LCS) or conventional Manual Cataract Surgery (MCS).
Primary purpose: DIAGNOSTIC

Brief summary: The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.

Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.


Eligibility criteria: Inclusion Criteria:

* Bilateral Age-related cataract necessitating lens extraction and posterior IOL implantation
* Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

Exclusion Criteria:

* Corneal abnormality
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Macular degeneration
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease

Primary outcomes:
measure: Central Macular Thickness
timeFrame: Baseline to 6 weeks postoperative
Secondary outcomes:
measure: Influence of lens density on quantitative autofluorescence
timeFrame: Baseline to 1 weel, 3 weeks and 6 weeks postoperative
measure: Central Macular Thickness
timeFrame: Baseline to 1 week, 3 weeks, 6 weeks postoperative
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical Universitiy of Vienna
name: Rupert Menapace, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reiter GS, Schwarzenbacher L, Schartmuller D, Roggla V, Leydolt C, Menapace R, Schmidt-Erfurth U, Sacu S. Influence of lens opacities and cataract severity on quantitative fundus autofluorescence as a secondary outcome of a randomized clinical trial. Sci Rep. 2021 Jun 16;11(1):12685. doi: 10.1038/s41598-021-92309-6.