louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01108731: The Effect of Milnacipran in Patients With Fibromyalgia
Official title: The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fibromyalgia
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

Detailed description: Patients with Fibromyalgia will show elevated ventricular lactate levels as measured via magnetic resonance spectroscopy (MRS). Patients treated with Milnacipran will show normalization of ventricular lactate levels compared to those treated with placebo, and will also show normalization of the increased latency to respond to complex reaction time probes compared to those treated with placebo.

Eligibility criteria: Inclusion Criteria:

* Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
* 18 through 68 years of age

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
* Patients who do not indicate their pain levels as less than substantial despite their best care
* History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
* Presence of current depression as determined by psychiatric diagnostic interview
* Presence of brain lesion on MRI anatomical study

Primary outcomes:
measure: Change in Ventricular Lactate Levels in the Brain
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).
timeFrame: Baseline and 2 months
measure: Change in Widespread Pain
timeFrame: 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Pain and Fatigue Study Center - Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Benjamin H Natelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Natelson BH, Vu D, Mao X, Weiduschat N, Togo F, Lange G, Blate M, Kang G, Coplan JD, Shungu DC. Effect of Milnacipran Treatment on Ventricular Lactate in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. 2015 Nov;16(11):1211-9. doi: 10.1016/j.jpain.2015.08.004. Epub 2015 Aug 31.
Clinical trial NCT06666231: Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block and External Oblique Intercostal Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: a Two-Center Randomized Controlled Trial
Official title: A Two-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 46
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: The primary aim of this study was to compare the postoperative analgesic efficacy of the Anterior Quadratus Lumborum Plane Block and the External Oblique Intercostal Plane Blocks used in laparoscopic cholecystectomy surgeries.


Eligibility criteria: Inclusion Criteria:

* Patients who will undergo laparoscopic cholecystectomy and who meet the ASA I-II risk classification between the ages of 18-65 will be included.

Exclusion Criteria:

Patients who do not agree to participate in the study, who have an infection in the application area, who are allergic to local anesthesia, who have coagulopathy, who are morbidly obese (Body mass index (BMI)\>35), who have a history of drug allergy, chronic pain, long-term opioid use and psychiatric illness, and who require emergency surgery are excluded from the study. will be left

-

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Postoperative 30.second,2 hours, 4 hours,12 hours,24 hours
Secondary outcomes:
measure: Opioid use
timeFrame: postoperative 24 hours
measure: Riker Sedation Agitation Scale
timeFrame: Immediately after extubation
measure: Patient satisfaction score
timeFrame: at the 24th postoperative hour
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Health Sciences University Gazi Yaşargil Training and Research Hospital
state: Kayapınar
Study officials:
References:
Clinical trial NCT03509831: [KJ-INT-002] BE Study
Official title: A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastritis
Lead sponsor: Kukje Pharma
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 37
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects


Eligibility criteria: Inclusion Criteria:

1. Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
2. Body weight \>= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m\^2 (inclusive).
3. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

1. Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
2. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
3. Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg.
4. Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.
5. Alanine aminotransferase, alkaline phosphatase \<=2x upper limit of normal (ULN) total bilirubin \> 2.0mg/dl and eGRF \<60mL/min/1.73m2
6. History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \>21 units for males. One unit is equivalent to 10 gram of alcohol.
7. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).

Primary outcomes:
measure: AUCt
timeFrame: One day
measure: Cmax
timeFrame: One day
Secondary outcomes:
measure: AUC∞
timeFrame: One day
measure: tmax
timeFrame: One day
measure: t1/2
timeFrame: One day
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Kukje Pharm
Study officials:
affiliation: Inha University Hospital
name: Sang-Heon Cho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05110482: Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients Undergoing Caesarean Section
Official title: Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients With Stenotic Valvular Heart Disease Undergoing Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adverse Effect of Oxytocic Drugs
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postpartum hemorrhage (PPH) is the primary cause of nearly one quarter of all maternal deaths globally. Management of uterine tone after delivery involves giving a prophylactic uterotonic and the use of controlled cord traction to facilitate delivery of the placenta and minimize blood loss. Syntocinon and carbetocin are the most commonly used drugs ,During caesarean delivery of stenotic valvular disease patient, the anesthesiologist have an important question: what is the best drug used for prevention of PPH with minimal hemodynamic effect regarding Systemic vascular resistance (SVR), Cardiac out put (COP),Heart rate ( HR), blood pressure? As uterotonic drugs may cause severe hypotension, decrease in SVR and COP that may not be tolerated by these patients .this thesis aims to compare between syntocinon and carbetocin regarding their effect on cardiac output and systemic vascular resistance using cardiometry in cardiac patients with stenotic lesions during caesarean delivery.


Eligibility criteria: Inclusion Criteria:

* Pregnant female single tone \>38 weeks
* Age :18-45 years old.
* patient with ASA III
* Cardiac patients ( mild and moderate mitral stenosis-aortic stenosis valve disease )

Exclusion Criteria:

* Other cardiac conditions (valve regurge, cardiomyopathy, heart failure,severe mitral stenosis, severe aortic stenosis, severe pulmonary hypertension)
* Pregnancy hypertensive disorders (eclampsia,preeclampsia)
* Abnormal placental attachment (accrete,percreta,increta)
* Patients with bleeding disorders
* patient with high risk of postpartum haemorrhage

Primary outcomes:
measure: Cardiac output
timeFrame: intraoperative
Secondary outcomes:
measure: systemic vascular resistance
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine CAIRO UNIVERISTY
Study officials:
References:
Clinical trial NCT01645982: Comparative Analysis of Cerebral Oximetry and Mean Arterial Pressures at the Cerebral Level in the Beach Chair Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Perfusion
Lead sponsor: Holy Cross Hospital, Florida
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic; Patients undergoing elective shoulder surgery

Brief summary: The purpose of this study is to compare the changes measured by Somanetics Invos cerebral oximeter to the mean arterial pressure at brain level in patients having elective shoulder replacement surgery. The Somanetics Invos System measures and monitors the oxygen saturation (rS02) of blood in the brain tissues to help prevent brain injury or other complications. The investigators hypothesize that maintaining normocarbia and systemic mean arterial pressure at or above 70mmHg during general anesthesia in the beach chair position will decrease the number of cerebral deoxygenation events during the procedure.


Eligibility criteria: Inclusion Criteria:

* Subjects must be undergoing elective shoulder replacement surgery
* Subjects must have an ASA class of I or II
* Subject is able and willing to sign the informed consent
* Subject is 18 years of age or older at time of consent
* Subject is not pregnant
* Subject is not a prisoner

Exclusion Criteria:

* Subject has a mental condition that may interfere with the subject's ability to give informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is younger than 18 years of age at consent
* Subject is pregnant
* Subject is a prisoner

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Orthopedic Research Institute
state: Florida
Study officials:
References:
Clinical trial NCT04040582: Psychedelics and Wellness Study (PAWS)
Official title: Psychedelics and Wellness Study (PAWS): An Online Anonymous Survey Investigating the Interrelationship Between Past Psychedelic Use and Its Impact on Levels of Wellness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Anxiety, PTSD
Keywords: Psychedelics, Wellness
Lead sponsor: WILD 5 Wellness
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 3234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages 18 and older that have taken a psychedelic at least once.

Brief summary: The Psychedelics and Wellness Study (PAWS), is an anonymous online survey investigating the interrelationship between psychedelics and wellness. The study population is adults ages 18 and older that have taken a psychedelic at least once. The maximum sample size is 5,000 survey respondents. It is expected that this anonymous online survey will support the hypothesis that there is a robust interrelationship between past psychedelic use and its impact on wellness.

Detailed description: Following a four-decade moratorium, the therapeutic use of psychedelics has once more captured the collective attention of the medical community and the public at large. Now, at the forefront of a renaissance in psychedelic research, this study is investigating the interrelationship of psychedelics and mental wellness - a state of well-being in which the individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community. This work will be unique in that it will collect both objective and subjective data to assess the interrelationship between psychedelic and wellness. It will lend support to the growing body of research in the use of psychedelics for both mental health conditions and the pursuit of overall mental wellness.

Eligibility criteria: Inclusion Criteria:

* Adults ages 18 and older that have taken a psychedelic at least once.

Exclusion Criteria:

* Individuals less than 18 years old and have previously never taken a psychedelic substance.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Through study completion, an average of 1 year
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Through study completion, an average of 1 year
measure: Change in HERO Wellness Scale
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: WILD 5 Wellness
state: Texas
Study officials:
affiliation: WILD 5 Wellness
name: Saundra Jain, PsyD, LPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01908582: A Study of Evacetrapib and Rifampin in Healthy Participants
Official title: Effect of Rifampin on the Pharmacokinetics of Evacetrapib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine how much evacetrapib gets into the blood stream and how long it takes the body to get rid of it when given with rifampin. The safety and tolerability of the two drugs, given together, will also be evaluated. The study will also look at blood cholesterol levels and levels of a hormone called cortisol before and after taking rifampin. Information about any side effects that may occur will also be collected.

For each participant, this study will include 2 periods in fixed order. The study will last approximately 29 days.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy males and females (of non child-bearing potential)
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2), inclusive, at screening

Exclusion Criteria:

* Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
timeFrame: Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
measure: Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
timeFrame: Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
measure: Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib
timeFrame: Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04283682: Intervention Facilitates Oral Feeding in Premature Infants
Official title: The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature
Keywords: Skin Contact
bresatfeeding
premature
oral feeding
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 148
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants

Detailed description: This study is conducted at the level 3 NICU of the Children's Hospital of Fudan University, Shanghai, People's Republic of China, a tertiary medical center. Infants admitted to the NICU are all outborn infants.

The study is approved by the Ethics Committee of the Children's Hospital of Fudan University. Signed parental consent is obtained before participants'entry into the study. The RCT is conducted to evaluate the effectiveness of skin-to-skin combined with breastfeeding reduce the transition time from tube feeding to independent oral feeding.

The recruited infants are assigned to intervention group and control group.

Data are presented as means ± sds for continuous variables with normal distribution and percentages (%) for categorical variables. One-way analysis of variance and Fisher exact test is used to compare infants' baseline characteristics among the two groups. All statistical analyses are conducted using SPSS. A p value of less than 0.05 is regarded as statistically significant.

Eligibility criteria: Inclusion Criteria:

* gestational age ≤30 weeks
* birth weight \< 1500g
* age of admission \<72 hours
* no congenital malformation

Exclusion Criteria:

* OI \> 40
* mother has trouble in communicating

Primary outcomes:
measure: Transition time from the initiation oral feeding to full oral feeding
timeFrame: During the procedure
Secondary outcomes:
measure: Exclusive breastfeeding at discharge
timeFrame: During the hospitalization, an average of 2 to 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Wanyuan Road 399,Minhang District, Shanghai,China
name: ling li Li
role: STUDY_CHAIR
References:
citation: Li L, Wang L, Niu C, Liu C, Lv T, Ji F, Yu L, Yan W, Dou YL, Wang Y, Cao Y, Huang G, Hu X. Early skin contact combined with mother's breastfeeding to shorten the process of premature infants </= 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial. Trials. 2021 Sep 17;22(1):637. doi: 10.1186/s13063-021-05605-x.