louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04530734: Blood Concentration in Lorazepam and Treatment in Adult Catatonia
Official title: Blood Concentration in Lorazepam and Treatment in Adult Catatonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catatonia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 100
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: 102 patients with catatonia. 70 responder patients, 32 non responder

Brief summary: Catatonia is a severe form of psychomotor disturbance with a heterogenous presentation. It affects approximately 10% of acute psychiatric inpatients. According to the fifth edition of DSM-5 the diagnosis of catatonia can be made when three or more symptoms from the twelve following are present : catalepsy, waxy flexibility, stupor, agitation, mutism, negativism, posturing, mannerisms, stereotypies, grimacing, echolalia, echopraxia. It can occur in various psychiatric diseases, including mood disorders or schizophrenia, but also in various non-psychiatric disorders \[metabolic disturbances, viral infections (including HIV), typhoid fever, heat stroke, and autoimmune disease\].

Benzodiazepines, especially LORAZEPAM, are the most common initial treatment, with a remission rate of approximately 70-80 %, regardless of the cause or the clinical manifestations. This first line treatment is titrated gradually according to the therapeutic response over a few days up to 20-25 mg per day. Electroconvulsive therapy (ECT) is initiated on patients with catatonia who do not respond to benzodiazepines.

Interestingly, pharmacogenetic variants can alter the metabolism of lorazepam (e.g., the UGT2B15 \* 2 allele slows it down).

The main objective of this study is to assess the link between clinical response to lorazepam, residual plasma concentrations of lorazepam after 72 hours of fixed dosage, and the existence of genetic polymorphisms modifying the metabolism of lorazepam. Our hypothesis is that non-responding patients have lowered blood concentrations of lorazepam associated to a genetic profile of rapid metabolism. Evaluating the predictive factors of the response to treatment would allow early and precise identification of non-responder patients in order to adapt their first-line treatment.


Eligibility criteria: Inclusion Criteria:

* catatonia according DSM-5

Exclusion Criteria:

* Subject is less than 18 years of age
* Subject is pregnant at the time of the study
* Subject/legal guardian unwilling to participate in the study

Primary outcomes:
measure: Plasma concentrations of lorazepam measured after 72 hours of treatment with lorazepam at fixed dose
timeFrame: at 72 hours of treatment with lorazepam
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Fontan, CHU lille
Study officials:
affiliation: University Hospital, Lille
name: Ali AMAD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054534: Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads
Official title: Real-time Ultrasound Guided Placement of Sacral Quadripolar Leads With Ultrasound Image Fusion of Acquired Magnetic Resonance Scan (MRI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Traxtal
First posted: 2010-01-22
Enrollment: 1
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of the pelvis to guide a needle to the second sacral foramen using the posterior approach and place a interstim lead.


Eligibility criteria: Inclusion Criteria:

* Patient consented for Interstim lead placement

Exclusion Criteria:

* Patients requesting not to be in the study.
* Pregnant patients

Primary outcomes:
measure: Identify the third sacral foramen of the pelvis through US image fusion technology
timeFrame: at time of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Steven Clendenen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05726734: Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
Official title: Efficacy of Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori Infection
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.


Eligibility criteria: Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with no previous treatment experience

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Yingjie Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04883034: Adductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty
Official title: Adductor Canal Block in Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Total Knee Arthroplasty
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 60
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single-shot Adductor Canal Block in the outpatient clinic is safe, significantly decreased pain and analgesic consumption and may enhance the rehabilitation program

Detailed description: The ACB in the outpatient clinic is safe and can minimize postoperative pain. The primary goal of this research was to see how ACB affected the Visual Analog Score (VAS) pain score during the rehabilitation as opposed to controls. The secondary goal was to determine how much analgesic (etoricoxibe) was consumed on a daily basis.

Eligibility criteria: Inclusion Criteria:

* Indonesian or Javanese-speaking adults
* After perfomed total knee replacement
* American Society of Anesthesiologists physical status I-III
* body mass index (BMI) of 18-40 kg/m2

Exclusion Criteria:

* Declined to complete the study
* Unable to cooperate
* had an allergic reaction to any of the drugs
* abusing alcohol or drugs

Primary outcomes:
measure: Visual analog pain score (VAS)
timeFrame: one month
Secondary outcomes:
measure: analgesic oral intake (etoricoxibe)
timeFrame: one month
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Sholahuddin Rhatomy
state: Yogyakarta
Study officials:
affiliation: Gadjah Mada University
name: sholahuddin rhatomy, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04763434: Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study
Official title: Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dexamethasone
Dexmedetomidine
Ropivacaine
Lobectomy
Lead sponsor: Gansu Provincial Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.

Detailed description: Design: A prospective, randomized, controlled study Setting: Single-center university hospital. Participants: The study included 90 patients undergoing lobectomy under general anesthesia.

Interventions: The patients were allocated randomly into the following 3 groups: 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone (RS group) or 1 µg/kg dexmedetomidine (RM group), or with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group). Ultrasound-guided TPVB was performed at 4 points-T4-5, T5-6, T6-7, and T7-8 of the surgical side; 5 mL of solution were injected at each point. Postoperatively, the PCIA was used as part of multimodal analgesia, and all patients recieve .

Eligibility criteria: Inclusion Criteria:

ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old.

Exclusion Criteria:

Refusal for TPVB Inability to obtain informed consent Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 Pregnancy Infections at the site of injection for the TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases

Primary outcomes:
measure: the duration of analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: total sufentanil consumption
timeFrame: 48 hours after surgery
measure: VAS
timeFrame: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
measure: adverse effects
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01948934: Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Official title: Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wound
Keywords: Skin
Injury
Membrane amniotic
Wound
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of use of a new therapeutic strategy for the treatment of patients with large wounds

Detailed description: Amniotic membrane (AM) is a useful tissue as a biological dressing with numerous advantages it has a very similar structure to the skin and his biological and immunological properties.

Eligibility criteria: Inclusion Criteria:

* Acute wounds in granulation phase with a minimum surface of 100cm2
* ≥ 18 years
* signing informed consent form
* guarantee adherence to protocol

Exclusion Criteria:

* chronic arterial insufficiency
* pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method
* involved in other assay
* previous disease; kidney, heart, hepatic, systemic or immune
* inability to understand informed consent form

Primary outcomes:
measure: serious adverse events
timeFrame: 12 months
measure: inflammatory changes
timeFrame: 12 months
Secondary outcomes:
measure: wound evaluation
timeFrame: 12 months
measure: immunological evaluation
timeFrame: 12 months
measure: histological evaluation
timeFrame: 12 months
measure: microbiological evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Gregorio Castellanos Escrig MD
state: El Palmar
Study officials:
affiliation: Hospital Clinico Universitario Virgen de la Arrixca
name: Gregorio Castellanos Escrig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06797934: Establishment of a Registry of Patients With Parathyroid Disease
Official title: Establishment of a Registry of Patients With Parathyroid Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperparathyroidism
Hypoparathyroidism
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion in the registry will be offered consecutively to any patient with parathyroid pathology (hyperparathyroidism or hypoparathyroidism) diagnosed and evaluated at the Endocrinology Operating Unit through at least two endocrinology visits. The registry will include patients seen from 1/1/2000 for a duration of 30 years. Follow-up duration for each patient is expected to be 10 years, with enrollment until 12/31/2029, and registry update deadline on 12/31/2039.

Brief summary: Establishment of a registry with which to census all patients under the care of the O.U. Endocrinology for parathyroid pathology in order to longitudinally evaluate biochemical, clinical, radiological, medico-nuclear and histological data in future studies.

Detailed description: Inclusion in the registry will be offered consecutively to any patient with parathyroid pathology (hyperparathyroidism or hypoparathyroidism) diagnosed and evaluated at the Endocrinology Operating Unit through at least two endocrinology visits. The registry will include patients seen from 1/1/2000 for a duration of 30 years. Follow-up duration for each patient is expected to be 10 years, with enrollment until 12/31/2029, and registry update deadline on 12/31/2039.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosis of hyperparathyroidism or hypoparathyroidism based on biochemical parameters (calcemia, parathormone, phosphormia, creatinine, albumin, vitamin D25OH)
* Obtaining informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Longitudinal Biochemical Monitoring in Patients with Parathyroid Pathology
timeFrame: through study completion, an average of 15 years
measure: Clinical Outcomes in Parathyroid Pathology: Symptom Severity, Biochemical Parameters, and Comorbidities
timeFrame: through study completion, an average of 15 years
measure: Radiological Assessments in Parathyroid Pathology: Imaging Findings and Anatomical Evaluation
timeFrame: through study completion, an average of 15 years
measure: Medico-Nuclear Outcomes: Parathyroid Imaging and Functional Assessment
timeFrame: through study completion, an average of 15 years
measure: Histopathological Characteristics of Parathyroid Pathology
timeFrame: through study completion, an average of 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Uberto Pagotto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05938634: A Randomized Controlled Trial Using Stage-matched Intervention Based on the Transtheoretical Model of Change to Enhance Engaging in Regular Physical Exercise Among High School Female Students.
Official title: Efficacy of Stage Matched Intervention Based on the Transtheoretical Model of Change in Enhancing Female High School Students' Readiness to Engage in Regular Physical Exercise: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Exercise
Lead sponsor: University of Baghdad
Sponsor class: OTHER
Collaborators: name: Nisreen Hameed Jebur
First posted: 2023-07-10
Enrollment: 144
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: A randomized controlled trial that uses a Stage-matched intervention based on the Transtheoretical Model of Change to enhance engaging in regular physical exercise among high school female students.

Detailed description: A randomized controlled trial that uses a Stage-matched intervention based on the Transtheoretical Model of Change to enhance engaging in regular physical exercise among high school female students.

The researchers will use two groups (study and control) in which participants will be randomly selected and assigned in each of the study and control groups using simple random sampling.

The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.

A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.

Eligibility criteria: Inclusion Criteria:

* High school female students who do not experience any physical disability.

Exclusion Criteria:

* High school female students who experience any physical disability.

Primary outcomes:
measure: Engaging in regular physical exercise
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
Study officials:
References:
Clinical trial NCT00619034: Pharmacological Intervention in Diabetic Retinopathy
Official title: Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.

Detailed description: Disturbances in retinal perfusion is believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practice. This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the retinal vessel diameter changes.

Eligibility criteria: Inclusion Criteria:

* Diabetes type 1 with moderate diabetic retinopathy/healthy
* Blood pressure \< 135/85 mmHg

Exclusion Criteria:

* Eye disease (excluding diabetic retinopathy)
* Allergic
* Kidney disease
* Liver disease
* Severe asthma
* Heart disease
* Hypertension arterial
* Users of drugs that influence the metabolism of the prostaglandins in the carbon dioxide
* Pregnant and breastfeeding women and women who don't use secure contraception
* Persons who can't do without contact lens in the treated eye.

Primary outcomes:
measure: Diameter of retinal blood vessels
timeFrame: one year
Secondary outcomes:
measure: Influence on retinal blood flow in diabetes
timeFrame: one year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology
Study officials:
affiliation: Department of Ophthalmology - Aarhus, Denmark
name: Kathrine K Tilma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05705934: Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia
Official title: Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
Collaborators: name: Ankara Yildirim Beyazıt University
First posted: 2023-01-31
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A decrease in muscle mass and function can cause the development of many chronic diseases, including sarcopenia. It has been reported that the best intervention for sarcopenia is exercise. Despite this, the optimal type of exercise for sarcopenia has not yet been determined. Although the holistic approach is used in the literature in the elderly population, it is noticeable that it does not find much space for itself in this patient group. In this study, it was aimed to examine the effects of holistic approach-based exercise program on individuals with sarcopenia.


Eligibility criteria: Inclusion Criteria:

* Being over the age of 65
* Getting a diagnosis of sarcopenia
* To be able to walk at least 10 meters independently in public
* Getting a score of 4 and above from the clock drawing test
* Volunteer individuals

Exclusion Criteria:

* Having a neurological disease
* Having an uncontrollable cardiopulmonary disease
* Acute illness that will prevent him/her from understanding and performing the exercises to be performed status or the presence of significant cognitive impairment
* Providing continuity for less than 80% of the exercise program

Primary outcomes:
measure: Muscle Mass
timeFrame: Change from baseline at 12 weeks
measure: The Timed Up&Go Test
timeFrame: Change from baseline at 12 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: SARC-F Questionnaire
timeFrame: Change from baseline at 12 weeks
measure: Charlson Comorbidity Index
timeFrame: Change from baseline at 12 weeks
measure: 30-Second Chair Stand Test
timeFrame: Change from baseline at 12 weeks
measure: Hand Grip Strength
timeFrame: Change from baseline at 12 weeks
measure: Berg Balance Test
timeFrame: Change from baseline at 12 weeks
measure: Depression
timeFrame: Change from baseline at 12 weeks
measure: Mini Nutritional Assessment (MNA)
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
Study officials:
References: