louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05813366: Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
Official title: Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Dysphoric Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 39
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome (PMS) affecting up to 8% of reproductive age women. It is characterized by physical and psychological symptoms that occur in the luteal phase of the menstrual cycle, prior to the onset of menses, and leads to negative impact on the psychosocial functioning of affected individuals.

Selective serotonin reuptake inhibitors are usually used to treat PMDD but they have several side effects so it is important to use complementary treatment such as tryptophan-rich diet and acupuncture for women with PMDD . The purpose of the current study is to determine the combined effect of tryptophan-rich diet and acupuncture on depression related to premenstrual dysphoric disorder

Detailed description: This study will be conducted on 39 participants suffering from premenstrual dysphoric disorder (PMDD). They will be recruited from Horus University, New Damietta, Egypt.

Eligibility criteria: Inclusion Criteria:

* All females will be clinically diagnosed with premenstrual dysphoric disorder (PMDD) as confirmed and referred from the gynaecologist.
* All females will be firstly assessed by Hamilton Depression rating scale (HDRS) for two months to confirm depression related to PMDD before participating in the study.
* Their ages will be ranged from 20 to 30 years.
* Their BMI will be ranged from 20 to 25 kg/m.
* Being virgin.
* Having regular menstruation for the last 6 months (every 28- 35 days with no intermittent bleeding).
* All females have a sedentary lifestyle.
* Voluntary acceptance of participation in the study

Exclusion Criteria:

* Using hormonal contraception (such as oral contraceptives and injections).
* Menstrual irregularity.
* Using diuretics or psychiatric medications.
* Using chronic non-steroidal anti-inflammatory drugs.
* Pre-diagnosed with any other psychological problems not related to PMDD.
* Follow any exercise programs.

Primary outcomes:
measure: The Premenstrual Symptoms Screening Tool (PSST)
timeFrame: Up to 2 months
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: Up to 2 months
Secondary outcomes:
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - short form
timeFrame: Up to months 2
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005566: Cognitive Aspects of Adolescent Suicide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide, Attempted
Keywords: Suicide
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-04-24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to pilot a new scale, The Desperation Scale, in a sample of young adolescents (aged 10-16) seen in the pediatric emergency room who require a psychiatric consultation. The proposed study is designed to assess the psychometric properties of this new scale and to provide information about the cognitive state of young suicidal individuals. It is hypothesized that this scale will be able to discriminate between those who are suicidal and those who are not. Data obtained in this pilot study will provide information about the usefulness of the construct of desperation and will guide future projects aimed at the assessment and treatment of suicidal individuals. The use of cognitive factors to predict suicidal behavior is appealing because they allow the clinician to tap into an individual's perception of his/her life circumstances. However, we believe the popular conceptualization of suicide as a result of "hopeless" thinking ignores an important aspect of suicidal behavior-the motivation to escape. We propose that a model of suicidal behavior that includes escape motivation, which we call the desperation model, will be better able to predict suicide than existing measures. We conceptualize desperation as consisting of three core elements: a sense of entrapment, feelings of anxiety/agitation, and a sense of time urgency. The current pilot study will test a 35-item scale that assesses these three elements of desperation. A pilot study of the Desperation Scale is currently being conducted at the Cornell University Medical Center (P.I. P.M. Marzuk) with depressed, adult inpatients. Our study is original in its use of the scale with an adolescent population and its focus on patients in the emergency room, when they are presumably in a "purer" suicidal state. It is hypothesized that those who are admitted to the emergency room for recent suicidal behavior will endorse feelings of entrapment, anxiety, and time urgency.


Eligibility criteria: Inclusion Criteria:

* young adolescents seen in the pediatric emergency room at Yale-New Haven Hospital who require psychiatric consultation and who give consent to participate

Exclusion Criteria:

* diagnosis of a psychotic or organic brain disorder or inability to read the study questionnaire due to low IQ, learning disability, or non-English speaking status

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Department of Psychology, Yale University
state: Connecticut
Study officials:
References:
Clinical trial NCT04358666: Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
Official title: Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Brain Metastases
Keywords: brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
Primary purpose: OTHER

Brief summary: Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion.

second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol

Detailed description: A patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion.

No previous study has focused on quality of life regarding these two treatments options.

Eligibility criteria: Inclusion Criteria:

* eligible for both treatments options OMS status \<3 primary cancer with no evolution brain metastasis \< 3cm ou giving symtoms patient with informed consent patient affilated to french social security

Exclusion Criteria:

* OMS \> 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery

Primary outcomes:
measure: quality of life EORTC QLQ C30
timeFrame: change between baseline and 6 month
Secondary outcomes:
measure: local control of the desease
timeFrame: baseline up to 24 month
measure: survival without progression
timeFrame: 24 month
measure: overall survival
timeFrame: 24 month
measure: medico economic evaluation
timeFrame: 24 month
measure: neuro cognitive evaluation
timeFrame: 12 and 24 month
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU CAEN
Study officials:
References:
Clinical trial NCT05774366: Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture
Official title: Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this prospective, randomized study is to compare recovery characteristics between remimazolam anesthesia with flumazenil and desflurane anesthesia in patients undergoing closed reduction of nasal bone fracture. The main question this study aims to answer is:

* Is there statistically significant difference in time from discontinuation of the anesthetic agent up to patient's response to verbal command between these two groups?

Participants will receive either remimazolam or desflurane for the maintenance of general anesthesia. When the surgery ends, the anesthetic agent will be stopped. For Remimazolam group, flumazenil will be administered as an antagonist of remimazolam.


Eligibility criteria: Inclusion Criteria:

* Age between 19 and 75 years
* American Society of Anesthesiologists physical status (ASA PS) of I-II
* Patients undergoing elective closed reduction of nasal bone fracture

Exclusion Criteria:

* Patient who cannot understand the process of this study
* Cognitive, visual or hearing impairment
* Chronic use of antipsychotic medications or medications for sleeping problem
* Use of benzodiazepine
* Patient with kidney or liver disease
* Body mass index (BMI) \>30 kg/m\^2

Primary outcomes:
measure: Time to follow verbal command
timeFrame: from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes
Secondary outcomes:
measure: time to eye opening
timeFrame: from discontinuation of anesthetic agent to eye opening, up to 30 minutes
measure: time to extubation
timeFrame: form discontinuation of anesthetic agent to extubation, up to 30 minutes
measure: Incidence of agitation during emergence period
timeFrame: from discontinuation of anesthetic agent to 2 minutes after extubation
measure: Mean arterial blood pressure
timeFrame: from 5 minutes before anesthesia induction to end of anesthesia
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: So Young Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04244266: Observational Study in Bariatric Surgery
Official title: Observational Study of the Pharmacological Reversal of the Residual Neuromuscular Blockade in Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Neostigmine
Residual Neuromuscular Blockade
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients whose BMI will be higher than 35 kg/m²

Brief summary: Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage.

According to the French guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. In morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. To calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight.

Due to this practice variability, It may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.


Eligibility criteria: Inclusion Criteria\*:

* Adult obese patients (≥ 18 years and BMI ≥ 35 Kg/m²), both sexes
* Any elective bariatric surgery
* Neuromuscular blockade with rocuronium
* Maintenance of anesthesia with a halogenated agent
* Free patient, without guardianship or subordination
* Patients with a social security coverage
* No opposition given by the patient after clear and fair information

Exclusion Criteria\*:

* Patients with hypersensitivity to the active substance or to other derivatives, or to any of the excipients of neostigmine,
* Emergency surgery,
* Severe renal and / or hepatic insufficiency,
* Persons benefiting from enhanced protection, namely pregnant women, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally sick people in emergency situation.

Primary outcomes:
measure: Compare the mean delay to recovery of neuromuscular blockade after pharmacological reversal according to the dosage of neostigmine administered to the patient (on TBW, IBW or ABW
timeFrame: Few minutes after injection of neostigmine
Secondary outcomes:
measure: Compare the frequence of side effects according to the dosage of neostigmine administered (on TBW, IBW or ABW)
timeFrame: Within one hour after the injection of neostigmine
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
Clinical trial NCT06439966: Expanded Access to ABBV-787
Official title: Expanded Access to ABBV-787
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Acute Myeloid Leukemia
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-06-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-787 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

- The participant must not be eligible for an ABBV-787 clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06490666: (∆PI) to Predict Post-spinal Anesthesia Hypotension
Official title: The Change in Femoral Artery Pulsatility Index as a Novel Predictor to Post-spinal Hypotension in Adult Patient Undergoing Infraumbilical Surgeries, a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia Hypotension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patient undergoing spinal anesthesia for infra-umbilical surgeries

Brief summary: we aimed to evaluate the change in femoral artery pulsatility index as a predictor to post-spinal anesthesia hypotension

Detailed description: After spinal anesthesia, hypotension is a common effect that occurs in between 15 and 30% of patients therefore it is essential to prevent such effect.

number of variables were utilized for estimating post spinal hypotension, such as assessing heart rate variability, perfusion index, inferior vena cava collapsibility index; however, the majority of these indices needs advanced equipment.

investigator of current research decided to study the role of ultrasound derived index namely pulsatility index to predict post spinal anesthesia hypotension.

Eligibility criteria: Inclusion Criteria:

* adult patient undergoing infra-umbilical surgeries.

Exclusion Criteria:

* coagulopathy peripheral vascular disease contraindication to spinal anesthesia

Primary outcomes:
measure: change in pulsatility index to predict post spinal anesthesia induced hypotension
timeFrame: baseline and immediately after spinal anesthesia
Secondary outcomes:
measure: change in resistive index to predict post spinal anesthesia induced hypotension
timeFrame: baseline and immediately after spinal anesthesia
measure: change in waveform morphology to predict post spinal hypotension
timeFrame: before and immediately after spinal anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
citation: Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.
citation: Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
citation: Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.
Clinical trial NCT02359266: Vitamin D Improves Depression in Liver Patients
Official title: Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Chronic Liver Disease
Keywords: Mood
Vitamin D deficiency
Adjuvant treatment
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with normal vitamin D levels will be monitored as controls, and they will not receive any intervention.

Detailed description: Patients with chronic liver diseases regularly suffer from vitamin D deficiency and depression. A recent meta-analysis reported an inverse correlation between depression and vitamin D levels. Indeed, vitamin D receptor is present and genomic and nongenomic vitamin D receptor-mediated signalling has been described in brain.

This intervention study investigates whether vitamin D therapy ameliorates depressive symptoms in chronic liver disease patients.

The investigators hypothesise that depressive symptoms will improve upon vitamin D replacement therapy.

Eligibility criteria: Inclusion Criteria:

* men and women
* over 18 years of age
* chronic liver disease

Exclusion Criteria:

* severe hepatic encephalopathy (CFF \<35 Hz)
* Interferon treatment
* hypercalcaemia (\>2.7 mmol/l) or hypercalciuria (\>8.0 mmol/d) with or without hyperparathyroidism (\>65.0 pg/ml)
* history of calcium-containing kidney stones
* allergy or hypersensitivity to any of the supplement ingredients: peanuts, soy, gelatin
* sarcoidosis
* stage IV or V Chronic Kidney Disease
* Pregnancy

Primary outcomes:
measure: Changes to depressive symptoms as assessed using the BDI-II score
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Changes to serum liver function tests, as assessed using standard clinical-chemical assays
timeFrame: 3 and 6 months
measure: Changes to bone density, as assessed using Dexa scans
timeFrame: at 12 months
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University Medical Center
state: Saarland
Study officials:
affiliation: Saarland University Medical Center
name: Frank Lammert, MD
role: STUDY_CHAIR
affiliation: Saarland University Medical Center
name: Caroline S Stokes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04504266: Perioperative Optimization With Enhanced Recovery
Official title: Perioperative Optimization With Enhanced Recovery: The Effect of Health Habits on Surgical Outcomes in Patients Undergoing Major Abdominal Operations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complication of Surgical Procedure
Keywords: prehabilitation, exercise, nutrition
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 368
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 randomized controlled trial examining the effect of a motivational interview and perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The hypothesis is that such an intervention will improve surgical outcomes. Patients who are planned to undergo major elective abdominal surgery will be randomized to standard care or the nutrition/exercise intervention. This intervention consists of a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.


Eligibility criteria: Inclusion Criteria:

* major abdominal surgery in 3+ weeks
* English or Spanish speaking

Exclusion Criteria:

* Unable to use smartphone

Primary outcomes:
measure: Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Change in 6 minute walk test
timeFrame: It will take about 6 minutes to assess, and this will be performed at enrollment, right before surgery, and at 30 and 90 days after surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Cindy Kin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Brendan Visser, MD
role: PRINCIPAL_INVESTIGATOR
References: