louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00571545: The Effect of Exercise on Mood After Traumatic Brain Injury
Official title: The Effect of Exercise on Mood After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Depression
Keywords: Traumatic brain injury
Depression
Exercise
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 78
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We proposed to examine the effect of an aerobic exercise intervention on depression in persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury who are assigned to receive the exercise intervention with those in the control group to determine the effect of exercise on levels of depression and specific symptoms related to depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise on activity, participation level, and quality of life will be examined.

HYPOTHESES:

1. Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
2. Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.
3. Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
4. Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.


Eligibility criteria: Inclusion Criteria:

* Traumatic brain injury 1-5 years prior to enrollment
* Current depression as measured by a score of 5 or greater on the depression portion of the Physician Health Questionnaire (PHQ).
* Sufficient cognitive ability to maintain participation in the study
* Sufficient English language ability to allow participation without an interpreter

Exclusion Criteria:

* Current suicidal ideation with intent or plan
* Currently pregnant
* History of significant cardiovascular or respiratory disease
* History of significant cardiovascular or respiratory disease
* Physical barriers to the use of standard aerobic exercise equipment

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 10 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kathleen R Bell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffman JM, Bell KR, Powell JM, Behr J, Dunn EC, Dikmen S, Bombardier CH. A randomized controlled trial of exercise to improve mood after traumatic brain injury. PM R. 2010 Oct;2(10):911-9. doi: 10.1016/j.pmrj.2010.06.008.
Clinical trial NCT03141645: Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC
Official title: Comparison of Preoperative Intravenous Fluid Loading and Ondansetron in Reduction of Incidence Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea
Postoperative Vomiting
Postoperative Nausea and Vomiting
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
Collaborators: name: Buddhachinaraj Hospital
First posted: 2017-05-05
Enrollment: 171
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: PREVENTION

Brief summary: This study is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C).

Detailed description: This study is a prospective randomized control trial. It is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C). This study is hypothesized that the incidence of PONV in patients receiving preoperative intravenous fluid loading (group F) and patients receiving ondansetron (group O) will be similarly reduced from the control group (receiving neither fluid nor ondansetron).

Eligibility criteria: Inclusion Criteria:

* patients with aged 18 to 70 years with an ASA physical status 1-3

Exclusion Criteria including patients

* with pregnant or breast-feeding patients
* having history of taking antiemetic drugs within 24 hours before surgery
* with hypersensitivity or allergy to ondansetron
* with CKD stage 4, 5
* with congestive heart failure, LVEF \<40
* with cirrhosis child c
* refusal or cannot communicate or understand the purpose of this study

Primary outcomes:
measure: The incidence of postoperative nausea and vomiting
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mingkwan Wongyingsinn
Study officials:
affiliation: Faculty of Medicine Siririaj Hospital
name: Mingkwan Wongyingsinn, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wongyingsinn M, Peanpanich P, Charoensawan S. A randomized controlled trial comparing incidences of postoperative nausea and vomiting after laparoscopic cholecystectomy for preoperative intravenous fluid loading, ondansetron, and control groups in a regional hospital setting in a developing country. Medicine (Baltimore). 2022 Oct 21;101(42):e31155. doi: 10.1097/MD.0000000000031155.
Clinical trial NCT06312345: Ciprofol Versus Propofol for Anesthesia Induction in Cardiac Surgery: A Randomized Double-blind Controlled Clinical Trial
Official title: Ciprofol Versus Propofol for Anesthesia Induction in Cardiac Surgery: A Randomized Double-blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Shanghai East Hospital of Tongji University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited.


Eligibility criteria: Inclusion Criteria:

1. Elective surgery patients
2. Aged 55 to 75
3. New York Heart Association class II or III cardiac functions
4. Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures

Exclusion Criteria:

1. With a history of benzodiazepine allergy
2. Significant liver or kidney insufficiency
3. Coagulation dysfunction
4. Neurological or psychiatric disorders
5. Undergone major surgery within the past three months.

Primary outcomes:
measure: Mean arterial pressure
timeFrame: 1 second before induction of anesthesia (T1)
measure: Mean arterial pressure
timeFrame: 1 second before tracheal intubation (T2)
measure: Mean arterial pressure
timeFrame: 1 minute after tracheal intubation (T3)
measure: Mean arterial pressure
timeFrame: 5 minutes after tracheal intubation (T4)
measure: Heart beats
timeFrame: 1 second before induction of anesthesia (T1)
measure: Heart beats
timeFrame: 1 second before tracheal intubation (T2)
measure: Heart beats
timeFrame: 1 minute after tracheal intubation (T3)
measure: Heart beats
timeFrame: 5 minutes after tracheal intubation (T4)
Secondary outcomes:
measure: Oxygenation index
timeFrame: 1 second before induction of anesthesia (T1)
measure: Oxygenation index
timeFrame: 10 minutes after tracheal intubation (T5)
measure: Injection pain
timeFrame: During procedure (When injecting the drug, ask the subject if the injection site is painful)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital of Tongji University
state: Shanghai
Study officials:
References:
Clinical trial NCT01914445: Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine whether oral administration of Indigo Carmine together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used instead of staining during the examination itself.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from Inflammatory Bowel Disease
* Patients under surveillance for Disease-Associated Lesions and Masses (DALM)

Exclusion Criteria:

* All others

Primary outcomes:
measure: Efficacy of Indigo Carmine during oral administration
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Vitaly Verzhbitsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06686745: Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
Official title: A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Xianxiang Medical Technology Co., Ltd.
First posted: 2024-11-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation and signature of informed consent form.
2. Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer.
3. ECOG score of 0 or 1.
4. Expected survival ≥ 12 weeks.

Exclusion Criteria:

1. Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies/mL or≥2000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study.
2. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
3. Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug.
4. Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1).
5. Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later.
6. Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
Study officials:
References:
Clinical trial NCT00233545: Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
Official title: Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Leishmaniasis
Keywords: cutaneous
leishmaniasis
drug
miltefosine
Lead sponsor: AB Foundation
Sponsor class: OTHER
First posted: 2005-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.


Eligibility criteria: Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion.

Previous RX: No specific or putatively specific therapy for leishmaniasis (Sb, pentamidine, amphotericin B, imidazoles, allopurinol)

Other diseases: No concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT) and kidney function tests (creatinine).

Primary outcomes:
measure: cure rate
Secondary outcomes:
Other outcomes:
Locations:
city: Palos Blancos,
country: Bolivia
facility: Puesto de Salud, Campamento OSCAR,
Study officials:
affiliation: FADER
name: J Soto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830345: Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety of ATGC-100 Versus Botox in Subjects With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 290
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female aged 19 to 65 years old
2. Participants with Facial Wrinkle Scale (FWS) score of \> 2 at maximum frown at screening
3. Participants willing to follow the study procedures and schedules
4. Participants willing to give written informed consent to participate in the trial

Exclusion Criteria:

1. Participants with severe glabellar lines that cannot be improved physical method
2. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
3. Participants with known hypersensitivity to any component of the study drug
4. Participant who has skin disorder including infection and scar on injection site

Primary outcomes:
measure: Proportion of patients with improvement of glabellar lines at maximum frown
timeFrame: 4 weeks post injection compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji University Hospital
Study officials:
References:
Clinical trial NCT02759445: Myocardial Deformation Imaging After Acute Alcohol Excess
Official title: Detection of Early Changes in Left Ventricular Function by Myocardial Deformation Imaging After Acute Excessive Alcohol Ingestion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Dysfunction
Keywords: alcohol induced cardiomyopathy
myocardial deformation imaging
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are not used to alcohol and have no heart disease will be asked for an echocardipgraphy (at baseline and at 4 weeks follow-up) in case of excessive alcohol Ingestion up to 12 hours before determination

Brief summary: Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac dysfunction. In general, patients consuming alcohol more than five years are at risk for the development of dilated cardiomyopathy. As only few data about immediate changes in left ventricular function after acute excessive alcohol ingestion are available, this study sought to close this gap.

Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12 hours after alcohol excess and after 4 weeks of complete alcohol abstinence. Echocardiography will performed at baseline and at follow-up regarding conventional parameter \[as left ventricular ejection fraction (LVEF), transmitral early (E) and late (A) Doppler flow velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation time (IVRT)\] and myocardial deformation data \[as layer specific global circumferential (endo GCS, mid GCS, epi GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain\].


Eligibility criteria: Inclusion Criteria:

* healthy subjects who are not used to alcohol
* subjets who had an excessive alcohol Ingestion up to 12 hours before echocardiography

Exclusion Criteria:

* any heart disease
* subjects under 18 years

Primary outcomes:
measure: Myocardial Dysfunction by echocardiographic parameters
timeFrame: At 4 weeks follow-up
Secondary outcomes:
measure: Change from baseline in echocardiographic parameters
timeFrame: from baseline to follow up at 4 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Cardiology, RWTH Aachen University Hospital
Study officials:
affiliation: Department of Internal Medicine I, University Hospital Aachen
name: Michael Becker, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02552745: Preventive Effects of Parecoxib on Postoperative Complications in Hepatocellular Carcinoma Patients Undergoing Hepatic Transcatheter Arterial Chemoembolization
Official title: Sun Yat-sen University Cancer Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosed with HCC according to the "primary liver cancer diagnosis and treatment practices" published by the Ministry of Health in 2011 China.

Brief summary: This study is aiming to understand the effects of parecoxib on the postoperative complications of hepatocellular carcinoma (HCC) patients undergoing hepatic transcatheter arterial embolization (TACE). The investigators enrolled 242 patients who were diagnosed with HCC for the first time and who received hepatic TACE at the Cancer Prevention and Treatment Center of Sun Yat-sen University from October 2014 to March 2015 were prospectively enrolled. The patients were divided into study and control groups according to whether parecoxib sodium was administered postoperatively. Pain scores,body temperature, vomiting, and changes in liver function after surgery, as well as the length of the hospital stay, were recorded and compared.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with HCC according to the "primary liver cancer diagnosis and treatment practices" published by theMinistry of Health in 2011
2. A previous history of hepatitis B or positivity for hepatitis B surface antigen (HBsAg)
3. A Karnofsky Performance Status (KPS) score ≥70 points
4. Age between 18 and 65 years
5. Child-Pugh classA or B (class B patients had scores no greater than 7 points). In addition, the baseline laboratory tests had to meet the following criteria: white blood cells (WBCs) ≥1.5 × 109/L, platelets ≥50 × 109/L, hemoglobin ≥80 g/L, serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 x the upper limit of normal (ULN), serum creatinine ≤ 1.5 x ULN, an international normalized ratio (INR)\<1.5 or prothrombin time \< the ULN + 4 seconds, albumin ≥30 g/L, and total bilirubin ≤34mmol/L

Exclusion Criteria:

1. Patients who had iodine allergies, severe heart and lung diseases, significant fever or pain, or continuous use of anti-inflammatory drugs within the past three months were excluded

Primary outcomes:
measure: Pain scores
timeFrame: 3 days after TACE
Secondary outcomes:
measure: Body temperature
timeFrame: 3 Days after TACE
measure: Liver function
timeFrame: 2 days after TACE
measure: Hospital Stay
timeFrame: within 3 days after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01698645: Patient Satisfaction and Quality of Life Impact - PecFent®
Official title: A Spanish , Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breakthrough Cancer Pain
Keywords: quality of life
PecFent
Lazanda
fentanyl
intranasal
breakthrough cancer pain
Lead sponsor: Archimedes Development Ltd
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 150
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: Cancer patients with breakthrough pain

Brief summary: National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adult (aged ≥18 years) with cancer
* Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain

Primary outcomes:
measure: Satisfaction
timeFrame: Satisfaction will be assessed approximately 1 hour after each breakthrough pain (BTPc) episode treated with PecFent® from completion of titration through Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
References: