louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05329779: Study on Allopregnanolone and Depression in Perimenopausal Women
Official title: Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Depression
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.

Detailed description: Midlife women are burdened with depression risk that is at least partly attributed to changing reproductive steroid dynamics across a prolonged reproductive transition. The investigators hypothesize that declining endogenous allopregnanolone (ALLO) levels across the menopause transition underlies perimenopausal depression. This mechanistic trial aims to amplify the contrast between lower endogenous ALLO levels in perimenopausal women and higher levels experimentally induced by exogenous ALLO. This will be achieved by using the exogenous ALLO treatment, brexanolone, which is FDA-approved to treat depression in postpartum patients, in a randomized, double-blind, parallel-arm, placebo-controlled trial. By manipulating ALLO levels together with key measurement of depression domains, this study harnesses the endocrine biology of perimenopause to explicate behavioral and neurobiological mechanisms underlying depression in perimenopausal women.

Eligibility criteria: Inclusion Criteria:

* Healthy perimenopausal women ages 40 to 60 years
* Depressive symptoms
* Able to read Arabic numerals and perform simple arithmetic
* Able to provide written informed consent

Exclusion Criteria:

* Use of medications to treat depression
* Systemic hormone therapy
* Contraindicated medications with brexanolone
* Other psychiatric illnesses that are considered to be primary
* Current suicidal ideation
* Active substance use disorders
* Unstable medical conditions
* Obstructive sleep apnea or other primary sleep disorders
* Abnormal hepatic and renal function
* Known allergy to progesterone, exogenous allopregnanolone, or brexanolone
* History of head injury resulting in loss of consciousness \> 20 min
* Inability to comply with barrier contraceptive methods
* Known intellectual disability
* Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition
* Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data
* Inability to comply with study procedures

Primary outcomes:
measure: Within-person change in score on the Ruminative Responses Scale
timeFrame: Baseline to 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06712979: Addiction of Lung Volume Recruitment Technique in Lee Silverman Protocol for Voice Professionals
Official title: Comparison Between Lee- Silverman Method and Lung Volume Recruitment Tecnhique in Voice Professionals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Voice Quality
Singing
Keywords: voice training
acoustic
respiratory therapy
Lead sponsor: Escola Superior de Ciencias da Saude
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: all participants will perform adapted Lee Silverman Method (Adapt Lee) and Lung volume recruitment technique plus Adapt Lee during 2 weeks, with washout period of 6 weeks.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial in voice professionals with both genders aimed to verify the changes in the vocal range profile and the changes in the glottic and vocal tract configuration for more efficient phonation after applying the adapted Lee Silverman Method and the addiction of lung volume recruitment technique in acoustic and structural analysis.

Detailed description: A cross-over randomized trial with two arms-the Lee Silverman Method and the addiction of lung volume recruitment technique (LVRT)-will be conducted with voice professionals to assess the effects of both interventions on the acoustic, perceptive, and visual aspects of voice and their impact on respiratory muscle strength.

Eligibility criteria: Inclusion Criteria:

* Voice professionals with no voice disease

Exclusion Criteria:

* smokers
* Glottis paralysis and dysfunction
* dental problems
* Mental and cognitive disorders

Primary outcomes:
measure: Vocal Range Profile
timeFrame: 30 days
Secondary outcomes:
measure: functional laryngeal assessment
timeFrame: 30 days
measure: Respiratory muscle strength
timeFrame: 30 days
Other outcomes:
Locations:
city: Anapolis
country: Brazil
facility: Unievangelica
state: GO
Study officials:
References:
Clinical trial NCT04168879: Sphenopalatine Ganglion Block for Nasal Surery
Official title: Efficacy of Suprazygomatic Approach of Sphenopalatine Ganglion Block for Nasal Surery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Agitation
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: saeid metwaly abouelyazid elsawy
First posted: 2019-11-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge.


Eligibility criteria: Inclusion Criteria:

* patient written consent
* elective surgery
* age 18 - 55 year old

Exclusion Criteria:

* patient refusal
* emergency surgery

Primary outcomes:
measure: Postoperative emergence agitation
timeFrame: 2 hour
Secondary outcomes:
measure: postoperative opioid consumption
timeFrame: 24 hour
measure: surgical field quality
timeFrame: 2 hours
measure: consumed inhalational anesthesia
timeFrame: 2 hours
measure: postoperative pain
timeFrame: 2 hours
Other outcomes:
measure: intraoperative bleeding
timeFrame: 2 hours
Locations:
city: Asyut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT04265079: I2-CoRT WTP9: Upper Extremity Motor Intervention, Use of Hand Orthosis in People Post-stroke
Official title: I2-CoRT WTP9 Bovenste Extremiteit Motoriek Interventie Met Hand Orthese Bij Mensen na Een Beroerte
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Upper Extremity Dysfunction
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2020-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The upper extremity kinematics of people post-stroke will be monitored with/without an inactive hand orthosis (intervention: added weight to hand) during ARAT, Fugl-Meyer, and Box and Blocks tests. Measurements will occur right after inclusion and repeated once after 7-8 weeks. Upper extremity kinematics and test scores will indicate the influence of additional weight to hand as a possible confounder when, in the future, the hand orthosis would be used as a therapy tool.


Eligibility criteria: Inclusion Criteria:

* Post-stroke
* Receive regular therapy at Jessa hospital
* Able to willingly sign informed consent

Exclusion Criteria:

* Relapse during study
* Secundary complications limiting upper extremity performance

Primary outcomes:
measure: Action Research Arm Test
timeFrame: 0 weeks
measure: Action Research Arm Test
timeFrame: 8 weeks
measure: Fugl-Meyer
timeFrame: 0 weeks
measure: Fugl-Meyer
timeFrame: 8 weeks
measure: Box and Blocks
timeFrame: 0 weeks
measure: Box and Blocks
timeFrame: 8 weeks
measure: Upper extremity kinematics
timeFrame: 0 weeks
measure: Upper extremity kinematics
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03626779: Bone Density in Immediate Implant Placment and Loading(BDIIPL)
Official title: Prf Controlled,Randamized Cinical Trial of EFFECTS OF THE PLATELET-RICH FIBRIN (PRF) ON BONE DENSITY IN IMMEDIATE IMPLANT PLACEMENT AND LOADING IN ESTHETIC ZONE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Density Increased
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atrumatic extraction ,immediate implant placment , prf as plug,immediate loading , mesure bone density 0-3-6-9 month

Detailed description: Atrumatic extraction unrestorable tooth in esthetic zone and immediate implant placment and withdrow 10cc blood sample to gain prf plug as membrane and immediate provisional for one week and final restoration after 1 week , and mesure bone density from 0-3-6-9 month

Eligibility criteria: Inclusion criteria:

* unrestorable anterior tooth.
* Good oral hygine
* Adequate bone hieght apical to the alveolus of failing tooth to ensure primary stability .

Exclusion Criteria:

* systematic disease which affect osteointgration.
* Bad oral hygiene
* Broxism, clenching, deep bite, edge to edge and abnormal habits.
* Non-treated peeiodontal diseases.
* Pregnancy and smokers. Severe infection. Loss of labial crest after extraction of failing tooth.

Primary outcomes:
measure: Bone density enhancement with prf in immediate implant placment and loding
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04782479: Hand Position for Stylet Removal During Tracheal Intubation
Official title: The Effect of Practitioner's Hand Position on Tracheal Tube Movement While Removal of Stylet During Tracheal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Manikin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2021-03-04
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents in the department of Anesthesia and Pain Medicine

Brief summary: Investigators compared the tube movement between two situations; the one was that the practitioner's hand holding the tracheal tube was placed in the air, and the other was that the hand was placed on the manikin's cheek, while two residents took the roles of the practitioner and the assistant in tracheal intubation with a stylet for a manikin.

Detailed description: Residents who accepted spontaneous participation were randomly combined into teams of two each. For two residents in a team, each sequentially took on the role of a practitioner and once as an assistant for tracheal intubations by changing the position of the hand holding the tube; one time, the position of the hand holding the tube was placed in the air, and the other time, the position of the hand holding the tube was placed on the cheek of the manikin. For the assistant role, residents performed stylet removal with two hands. Investigators filmed a video of the tube movement while the assistant pulling up the stylet at 1/8x speed. While analyzing the captured videos, it was measured how much the tube held by the intubation practitioner went in front or how far back during the process of pulling the stylet.

Eligibility criteria: Inclusion Criteria:

* residents in the department of Anesthesia and Pain Medicine

Exclusion Criteria:

* refusal for participation

Primary outcomes:
measure: tube movement distance
timeFrame: procedure (at the time when the assistant pulling back the stylet)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
References:
Clinical trial NCT00099879: Study of BMS-275183 in Patients With Pre-treated Non-small Cell Lung Cancer
Official title: A Randomized, Two-Cohort Phase II Study of Two Doses of BMS-275183 Given on a Weekly Schedule in Patients With Pre-Treated Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-12-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Advanced or metastatic pretreated NSCLC
* Measurable disease
* Adequate hematologic, hepatic and renal functions
* ECOG Performance Status of 0-2

Exclusion Criteria:

* Inability to swallow capsules
* Recent significant cardiovascular disease
* Woman who are pregnant or breastfeeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Local Institution
state: California
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Maywood
country: United States
facility: Local Institution
state: Illinois
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Brussels
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Besancon
country: France
facility: Local Institution
state: Cedex
city: Saint-Herblain
country: France
facility: Local Institution
state: Cedex
city: Belfort
country: France
facility: Local Institution
city: Parma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Insitution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Shefield
country: United Kingdom
facility: Local Institution
state: Yorkshire
city: Manchester
country: United Kingdom
facility: Local Institution
Study officials:
References:
Clinical trial NCT04333979: The Effect of Drain Use on Patient Comfort in Laparoscopic Sleeve Gastrectomy
Official title: Effect of Drain Usage on Patient Comfort on Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: obesity
VAS
Pain
Laparoscopy
Sleeve
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-04-03
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: Introduction Laparoscopic sleeve gastrectomy surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

Detailed description: Question the necessity of routine use of drain in Laparoscopic sleeve gastrectomy surgeon

Eligibility criteria: Inclusion Criteria:

* Morbid obese patients

Exclusion Criteria:

* - Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during Laparoscopic sleeve gastrectomy and those who had previously undergone obesity surgery (revision surgery) were excluded

Primary outcomes:
measure: Pain Intensity measure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03764579: Dietary Habits and Sleep in Childhood Obesity
Official title: Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Life Style
Circadian Rhythms
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recruitment of obese children, classification according to sleep questionnaire and randomization in two groups to perform nutritional and sleep intervention. .

One group receives dietary intervention through recommendations. A group receives dietary and sleep intervention through recommendations. An analysis of the melatonin profile and metabolic and inflammatory status is performed by biochemistry at the beginning and end of the intervention. Determine if the intervention has improved the health of obese children.

Detailed description: This study is carried out in children aged 7 to 14 years who are overweight or obese, in which their state and circadian rhythm variation are related by means of melatonin, biochemistry and dietary and sleep questionnaires.

An intervention is performed in which patients are classified in evening and morning. After the classification, a randomized randomization is carried out in which one group receives dietary recommendations and another group receives dietary and sleep recommendations. After 6 months of follow-up the analyzes are performed again to observe possible differences with the initial values and compare it between both groups.

Eligibility criteria: Inclusion Criteria:

* children between 7 and 14 years old
* overweight or obese (Body Mass Index superior to 97th percentile for age and sex).

Exclusion Criteria:

* Medicine intake,
* hyperactivity,
* infectious inflammatory processes,
* elite athletes.

Primary outcomes:
measure: Body mass index measurement, percentile for age and sex
timeFrame: 6 months
Secondary outcomes:
measure: melatonin concentration profile in saliva
timeFrame: 6 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Pilar Codoñer Franch
Study officials:
References:
Clinical trial NCT01908179: Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Brain Tumor
Keywords: Sterotactic Radiosurgery
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic brain tumors undergoing, or have undergone, sterotactic radiosurgery (SRS)

Brief summary: This registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and imaging data (including anatomic and advanced imaging sequences obtained prior to and serially following SRS) will be archived in an online informatics platform, specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for Metastatic Tumors (CONDR - Mets).


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 yo) with a pathological diagnosis of metastatic brain cancer
* Participants must have \>4 tumors felt to require stereotactic radiosurgery
* Karnofsky scale of \> 70 at the time of initial treatment
* Age \< 80

Exclusion Criteria:

* Karnofsky scale \<70
* Age \> 80
* Inability to undergo MR imaging studies

Primary outcomes:
measure: Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS
timeFrame: At the time of SRS
measure: Quantitative measures of tumor number will be performed for each subject at the time of SRS
timeFrame: At the time of SRS
measure: Overall survival will be measured for each subject (in weeks from SRS to death)
timeFrame: Post-SRS
Secondary outcomes:
measure: Measures of ADC, rCBV, MTT and ktrans will be performed for each treated tumor at treatment and at 6 months following SRS
timeFrame: 6 months post SRS
measure: Time to progression (in weeks) will be measured for each treated tumor
timeFrame: Post-SRS
measure: Diagnosis of progression or radiation necrosis (made on clinical reflection at study's end) will be determined for tumors where diagnosis is in question at 6 and 12 months after SRS
timeFrame: 12 months post-SRS
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: