louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00731653: Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
Official title: An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: depression
combination
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: BrainCells Inc.
First posted: 2008-08-11
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049.

The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

Detailed description: Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study.
* Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.

Exclusion Criteria:

- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.

Primary outcomes:
measure: The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.
timeFrame: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: San Diego
country: United States
facility: Synergy Research Centers
state: California
city: Altanta
country: United States
facility: Atlanta Institute of Medicine & Research, Inc.
state: Georgia
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Beachwood
country: United States
facility: NorthCoast Clinical Trials
state: Ohio
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, L.P.
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Ltd.
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Maurizio Fava, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Andrew A Nierenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06556953: Evaluating the Risk of Postoperative Venous Thromboembolism in Cervical Cancer Patients
Official title: Development and Validation of Machine Learning Models to Evaluate the Postoperative Venous Thromboembolism Risk of Cervical Cancer Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: machine learning
postoperative VTE
cervical cancer
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 1174
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our data was collected from electronic case of the cervical cancer patients who underwent surgical treatment at the Cancer Hospital affiliated with Chongqing University between January 2019 and December 2022

Brief summary: The aim of this study is to develop a machine learning model to accurately predict the risk of venous thromboembolism in patients with cervical cancer after surgery.

Detailed description: Venous thromboembolism (VTE) is a common and life-threatening complication in patients with cervical cancer following surgery. The objective of this study is to develop a machine learning model with the potential to predict the risk of VTE in these patients postoperatively. We plan to employ partial dependence (PD) curves, breakdown (BD) curves, Ceteris-paribus (CP), and SHapley additive exPlanations (SHAP) values for a comprehensive analysis. The goal is to explore how different machine learning algorithms can be utilized as tools for personalized postoperative VTE risk assessment in cervical cancer patients.

Eligibility criteria: Inclusion Criteria:

* Confirmation of cervical cancer through pathological examination.
* Receipt of surgical treatment for cervical cancer at Chongqing University Cancer Hospital in China.
* Provision of comprehensive case information.

Exclusion Criteria:

* Patients under the age of 18.
* History of VTE caused by other reasons before surgery.
* Secondary cervical cancer or accompanying primary malignant tumor.

Primary outcomes:
measure: Whether the patient has developed VTE is determined based on the diagnostic criteria in the "Guidelines for the Prevention and Treatment of Tumor-Associated Venous Thromboembolism (2019 Edition)."
timeFrame: December 31, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT02286453: Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac
Official title: Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis of The knee
Benjakul
Alternative Medicine
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Thai Traditional Medical Knowledge Fund
First posted: 2014-11-07
Enrollment: 84
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)


Eligibility criteria: Inclusion Criteria:

1. Patients with primary osteoarthritis of knee with grade I-III of Kellgren \& Lawrence criteria
2. Not during breast feeding
3. Not during pregnancy with a good contraception
4. Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
5. Do not abuse drugs
6. Good cooperation

Exclusion Criteria:

1. BMI \> 32
2. History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
3. History of allergy diclofenac or allergy herbal medicine

Primary outcomes:
measure: Pain score
timeFrame: 28 days
Secondary outcomes:
measure: Pain score
timeFrame: 28 days
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University (Ruangsit campus)
state: Pathum Thani
Study officials:
References:
Clinical trial NCT03171753: Preoperative Anxiety and Music Therapy
Official title: Anxiety, Preoperative Stress and Music Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Music can reduce anxiety in adult patients awaiting surgical interventions. The study was designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory enzymes, skin resitance between surgical patients listening music vs no sound.

Detailed description: Patients undergoing elective surgical intervention will be allocated in two groups: Group M will listen prerecorded music through an individual headset for 30 min before the induction of anesthesia; Group C will listen no sound through an individual headset for 30 min before the induction of anesthesia The degree of stress and anxiety the patients will be assessed using questionnaire. Laboratory enzymes will be measured.

Heart rate, non invasive arterial pressure, pulse oximetry,skin resistance will be recorded. All the patients will receive continuous ECG holter recording .

To assess the effect of music therapy on the degree of autonomic modulation, HRV will be analyzed with traditional time and frequency measures.

Eligibility criteria: Inclusion Criteria:

* Elective surgical patients \>18 years old, after obtaining informed consent

Exclusion Criteria:

* patients with hearing impairment,
* any known psychiatric or memory disorder
* thyroid disease.
* atrial fibrillation
* pace-maker

Primary outcomes:
measure: cardiac monitoring
timeFrame: through study period (to 15 min before the application of headphones until 15 minutes after their removal
Secondary outcomes:
measure: questionnaire
timeFrame: questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones)
measure: laboratory test
timeFrame: enzyme level change early after the application of headphones from baseline (early before the application of headphones)
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Ospedali Riuniti
state: FG
Study officials:
References:
Clinical trial NCT01492153: NovoLet® Surveillance Study on Using Human Insulin System in Indonesia
Official title: A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 1981
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 1 or type 2 diabetes mellitus or other types of diabetes mellitus (gestational, drug induced or metabolic syndrome-related) who are prescribed NovoLet® human insulin in the course of their diabetes mellitus management can be enrolled in the study

Brief summary: This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus
* Type 2 diabetes mellitus
* Other types of diabetes mellitus (gestational, drug induced \[thiazide\] or metabolic syndrome-related)

Primary outcomes:
measure: Change in body weight
Secondary outcomes:
measure: Fasting blood glucose (FBG)
measure: 2 hours postprandial blood glucose (2-hr PPBG)
measure: HbA1c (glycosylated haemoglobin)
measure: Adverse events (AEs) including hypoglycaemic episodes
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1457)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05290753: Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Postoperative Clinical Outcomes
Official title: Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Short and long_term Clinical Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prokinetic Use After Emergency Intestinal Anastomosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prokinetic drugs used to accelerate healing of intestinal anastomosis of urgent cases which not prepared preoperative by increase intestinal motility and gastric emptying and decrease postoperative adhesions They are many types of prokinetics as cholinergic agonists, dopamine antagonist, serotonergic agonists and macrolides Agents of prokinetics administered immediately post operation and at the time of hospitalization

Detailed description: By evaluation the effect of prokinetic use versus non use after emergency intestinal intestinal anastomosis on short and long term clinical outcome It will be prospective cohort study which conducted in sohag university hospital Study will include patients presented with urgent anastomosis Inclusion criteria: all adults underwent emergency intestinal anastomosis Exclusion criteria: pediatrics, patients with comorbidities and patients with electively resection and anastomosis.

Primary goals are to detect effect of prokinetics on incidence of leakage rate Secondary outcomes include early bowel opening, enteral feeding, post operative pain, wound infection and adhesion formation rate.

Eligibility criteria: Inclusion Criteria:

* all adult patients

Exclusion Criteria:

* pediatrics
* patients associated with comorbidities
* patients with electively resection and anastomosis

Primary outcomes:
measure: Leakage rate
timeFrame: 5 days postoperative
Secondary outcomes:
measure: Early bowel opening
timeFrame: 3 days postoperative
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Of medicine, Sohag university hospital
Study officials:
affiliation: Professor of general surgery
name: Alaa eldin Hassan, Professor
role: STUDY_DIRECTOR
References:
citation: Acosta A, Camilleri M. Prokinetics in gastroparesis. Gastroenterol Clin North Am. 2015 Mar;44(1):97-111. doi: 10.1016/j.gtc.2014.11.008. Epub 2014 Dec 23.
Clinical trial NCT00011453: Protection Against Benzene Toxicity
Official title: NQO1 in Protection Against Benzene Toxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Aplastic Anemia
Keywords: NQO1
DT-diaphorase
Benzene
Leukemia
Aplastic anemia
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: We are investigating the role of an enzyme (NQO1) in protection against the bone marrow toxicity of the occupational and environmental toxicant benzene. All of the proposed studies involve use of human bone marrow cells in-vitro to define mechanisms of NQO1-mediated protection. Cells are obtained from healthy volunteers and protocols have undergone IRB review and approval.


Eligibility criteria: Healthy adult volunteers with blood counts in normal ranges and without evidence of hepatitis or HIV infection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
References:
Clinical trial NCT00186953: Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors
Official title: Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abdominal Neoplasms
Pelvic Neoplasms
Keywords: Ultrasound
Abdominal tumors
Pelvic tumors
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 14
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body.

Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."


Eligibility criteria: Inclusion Criteria:

* Age: 2-20 years old
* Subject has a known or suspected solid soft tissue tumor in the abdomen or pelvis.
* Subject is scheduled for other imaging or is already scheduled for an ultrasound or has already had adequate imaging performed at an outside institution.
* Subject is able to lie still for the exam without sedation.

Exclusion Criteria:

* Known or suspected hypersensitivity to albumin, blood or blood products.
* History of open heart surgery, cyanotic congenital heart disease or an axygen saturation of less than 96% as determined by pulse oximetry.

Primary outcomes:
measure: To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
timeFrame: Unknown-study temporarily closed.
measure: To learn the effects (good and bad) of using Optison during ultrasound.
timeFrame: Unknown-study temporarily closed.
measure: To learn if using Optison™ during ultrasound can show the size and location of a tumor, how the tumor is responding to chemotherapy, and whether it has moved into surrounding tissue.
timeFrame: Unknown-study temporarily closed.
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Mary E. McCarville, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson LN, Maguire JL, Lebovic G, Hanley AJ, Hamilton J, Adeli K, McCrindle BW, Borkhoff CM, Parkin PC, Birken CS; Applied Research Group for Kids! (TARGet Kids!) Collaboration. Duration of Fasting, Serum Lipids, and Metabolic Profile in Early Childhood. J Pediatr. 2017 Jan;180:47-52.e1. doi: 10.1016/j.jpeds.2016.09.005. Epub 2016 Oct 11.
Clinical trial NCT05604053: Motivation Effects During Cued Visual Search
Official title: Motivation Effects During Cued Visual Search
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: attention
visual search
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive each level of visual cue type and motivation.
Primary purpose: BASIC_SCIENCE

Brief summary: In this line of research, we are examining whether motivation increases the utilization of target (positive) or distractor (negative) color cues to improve visual attention performance.

Detailed description: When finding a search target, receiving a target cue or distractor cue can increase search efficiency. We are examining whether we can improve people's use of the cues to aid visual search performance if we increase their motivation through reward or time pressure.

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-

Primary outcomes:
measure: Button Press Reaction Time
timeFrame: During Testing (single day)
measure: Button Press Accuracy
timeFrame: During Testing (single day)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Nancy Carlisle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03063853: Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
Official title: Early Versus Late Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Wound, Infection (Following Delivery)
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-02-24
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 .

A randomized control trial.

Detailed description: A randomized controlled trial in which pregnant women undergoing a scheduled Elective cesarean delivery were assigned to skin closure with surgical staples and were randomly assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day 8 .

Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks. Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores. Secondary outcome measures are complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).

A group of 104 women is needed in order to achieve a clinically signiﬁcant effect with a power of 80%.

Eligibility criteria: Inclusion Criteria:

* elective cesarean delivery
* previous cesarean delivery performed using the Pfannenstiel method
* 36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.

Exclusion Criteria:

* emergency cesarean delivery
* clinical signs of infection at the time of CD, uncontrolled
* vunblanaced diabetes mellitus
* history of keloids

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS) scores.
timeFrame: 8 weeks postoperative
Secondary outcomes:
measure: complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).
timeFrame: 8 weeks postoperative
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson medical center
Study officials:
affiliation: Wolfson Medical Center- Tel Aviv University
name: Hadas Miremberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miremberg H, Barber E, Tamayev L, Ganer Herman H, Bar J, Kovo M. When is the right time to remove staples after an elective cesarean delivery?: a randomized control trial. J Matern Fetal Neonatal Med. 2020 Dec;33(23):4004-4009. doi: 10.1080/14767058.2019.1594189. Epub 2019 Mar 21.