louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00279123: Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer Hemorrhage
Lead sponsor: Kwong Wah Hospital
Sponsor class: OTHER
First posted: 2006-01-19
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.

There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.

This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.


Eligibility criteria: Inclusion Criteria:

* patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.

Exclusion Criteria:

* previous gastrectomy and vagotomy
* patient taking warfarin
* intake of anti-secretory drugs in the previous 48 hours

Primary outcomes:
measure: Rebleeding rate within 30 days after endoscopic therapy
Secondary outcomes:
measure: Transfusion requirement
measure: duration of hospital stay
measure: need for operative intervention
measure: mortality rate
measure: gastric pH
measure: side effects of pantoprazole
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, Kwong Wah Hospital
Study officials:
affiliation: Department of Surgery, Kowng Wah Hospital
name: Wai-ka Hung, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03787823: RCT-evaluation of Retzius-sparing Robotic Prostatectomy
Official title: Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Urinary Incontinence
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 186
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical transperitoneal anterior radical prostatectomy

Detailed description: We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative complications in patients over a follow up period of 12 months

Eligibility criteria: Inclusion Criteria:

* Indication for radical prostatectomy
* \>18 years old
* Literate
* Preoperatively continent
* informed signed consent for study

Exclusion Criteria:

* cT4-Cancer
* Withdrawl of consent to study

Primary outcomes:
measure: Urinary continence
timeFrame: 1 Week after Prostatectomy
Secondary outcomes:
measure: Resection margine
timeFrame: pathology report, approximately 1 week postoperatively
measure: Urinary continence
timeFrame: 3, 6 and 12 months after Prostatectomy
measure: Postoperative complications
timeFrame: First 12 months after Prostatectomy
measure: postoperative PSA
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
References:
Clinical trial NCT05109923: Onnit Labs New Mood Supplementation in Healthy College Students
Official title: The Effect of Onnit New Mood Supplementation in Healthy Collegiate Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: cortisol
mood
Lead sponsor: University of Idaho
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to assess the effectiveness of ONNIT Lab's New Mood™ dietary supplement in supporting optimal mood balance and reducing daily stress among collegiate-aged men and women. To be considered for this study, the participant must meet the following criteria: (1) current undergraduate student at the University of Idaho between 18-24 years of age, (2) have no known allergies to the ingredients of New Mood™ (Niacin, Vitamin B6, Magnesium, Valerian Extract, Lemon Balm Extract, L-Tryptophan. 5-Hydroxytryptophan, and Inositol) or the placebo (rice bran and maltodextrin), (3) not currently taking any mood/sleep supplementation or medications, (4) not currently seeking therapy or diagnosed with a psychological disorder, (5) not regularly using cigarettes, marijuana, or other illicit drugs, and (6) not pregnant or breastfeeding.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled collegiate men and women at the University of Idaho

Exclusion Criteria:

* Currently taking mood or sleep enhancing supplementation/medication
* Currently participating in counseling and/or therapy sessions
* Previously diagnosed with a psychological disorder

Primary outcomes:
measure: Change in cortisol awakening response (mg/dL) over 8 weeks
timeFrame: Change from baseline cortisol awakening response (mg/dL) at 8 weeks
measure: Change in resting heart rate (beats per minute) over 8 weeks
timeFrame: Change from baseline resting heart rate (beats per minute) response at 8 weeks
measure: Change in resting systolic and diastolic blood pressure (mm Hg) over 8 weeks
timeFrame: Change from baseline resting systolic and diastolic blood pressure (mm Hg) at 8 weeks
measure: Change in depression, anxiety and stress scores (0-34) over 8 weeks
timeFrame: Change from baseline DASS-21 score at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: United States
facility: University of Idaho
state: Idaho
Study officials:
References:
citation: Brown AF, Richardson CME, Newby N, Pulsipher S, Hoene T. Effect of a Multi-Ingredient Supplement Designed to Regulate Mood on Physiological and Psychological Outcomes: A Randomized, Double-Blind, Placebo-Controlled Trial. J Diet Suppl. 2023;20(4):631-642. doi: 10.1080/19390211.2022.2077880. Epub 2022 May 30.
Clinical trial NCT02649023: Deep Venous Thrombosis After Hepatobiliopancreatic Surgery
Official title: Pre- and Early Postoperative Deep Venous Thrombosis in Patients Undergoing Oncological Hepatic or Panreatic Resection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Venous Thrombosis
Pulmonary Embolism
Hepatectomy
Pancreatectomy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective oncological liver or pancreatic resection

Brief summary: To investigate the incidence of pre- and early postoperative deep venous thrombosis in patients undergoing hepatobiliopancreatic surgery, as well as potential corresponding risk factors with special attention to circulating tumor cells.

Detailed description: Thromboembolic events are a common cause of morbidity and mortality in oncological patients. Up to 20% of cancer patients suffer from venous thromboembolism (VTE) induced by the underlying malignancy itself. Oncologic gastrointestinal surgery is a well-known risk factor for VTE. About 4-6% of patients undergoing elective hepatobiliopanreatic surgery develop a deep venous thrombosis (DVT) or pulmonary embolism. However, there are no data referring to the incidence of DVT shortly ahead of the surgical event, implementing that a certain percentage of postoperative DVT might have already been acquired before the operation. Furthermore, most studies only evaluate the rate of symptomatic VTE. In this study, all patients undergoing hepatobiliopancreatic surgery will be screened for deep venous thrombosis the day before surgery, on the third postoperative day (primary endpoint) and 90 days after the operation with a 2-point compression sonography of the lower extremities. The development of a symptomatic VTE (DVT or pulmonary embolism) will be recorded as secondary endpoint. Risk factors, perioperative morbidity / mortality and presence of circulating tumor cells will be analyzed with regard to VTE incidence.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective oncological liver or pancreatic resection
* Age equal or greater than 18 years
* Written informed consent

Exclusion Criteria:

* Preexistent coagulopathy
* History of previous VTE
* benign disease

Primary outcomes:
measure: Deep venous thrombosis on day 3 after surgery
timeFrame: 3 days
Secondary outcomes:
measure: Symptomatic deep venous thrombosis or pulmonary embolism during hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU
Study officials:
affiliation: Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
name: Nuh Rahbari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04946123: Hyperthyroidism: Methimazole Plus L-carnitine and Selenium
Official title: Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthyroidism
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hyperthyroidism requiring therapy with methimazole

Exclusion Criteria:

* Drug and alcohol abuse;
* Pregnancy;
* Medically uncontrolled psychiatric conditions;
* Interfering therapies (lithium, interferone, TKI, amiodarone)

Primary outcomes:
measure: Hyperthyroidism symptoms
timeFrame: Change from baseline QoL at 6 months of supplementation
measure: Hyperthyroidism symptoms
timeFrame: Change from 6-months supplementation QoL at 12 months of intervention (end of study)
Secondary outcomes:
measure: TRAb
timeFrame: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
measure: TSH
timeFrame: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino
Study officials:
References:
Clinical trial NCT05536323: Bolus Versus Continuous Remimazolam for Anesthetic Induction
Official title: Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension on Induction
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion.

This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.


Eligibility criteria: Inclusion Criteria:

* scheduled for elective surgery under general anesthesia
* adult patient (over 19 years old)
* American Society of Anesthesiology Physical Status I-III

Exclusion Criteria:

* arrythmia
* liver dysfunction
* kidney dysfunction
* uncontrolled hypertension
* uncontrolled diabetes mellitus
* allergic to benzodiazepines
* heart failure
* drug intoxication
* alcohol intoxication

Primary outcomes:
measure: Incidence of hypotension
timeFrame: 10 minutes after anesthetic induction
Secondary outcomes:
measure: Incidence of bradycardia
timeFrame: 10 minutes after anesthetic induction
measure: The lowest systolic blood pressure
timeFrame: 10 minutes after anesthetic induction
measure: Number of participants with vasoactive drug use
timeFrame: 10 minutes after anesthetic induction
measure: Time to loss of consciousness
timeFrame: 10 minutes after anesthetic induction
measure: Dosage of remimazolam
timeFrame: 10 minutes after anesthetic induction
Other outcomes:
Locations:
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Cho E Ah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03455023: Individualized Pharmaceutical-care for Inpatients With Cancer Pain
Official title: Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Inpatients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Pain
Keywords: Cancer pain
Pharmaceutical care
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 500
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: The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients

Detailed description: This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older;
* Histologically confirmed solid tumor;
* Diagnosed chronic cancer pain;
* Opioid-tolerant patients;
* Overall survival is expected to be over 3 months;
* Karnofsky performance score≥50;
* Willing and able to comply with the protocol

Exclusion Criteria:

* Current pregnancy or breastfeeding;
* Patients diagnosed with non-cancer pain;
* Patients treated with patient-controlled analgesia;
* Patients with pathological fracture, gastrointestinal obstruction, severe infection, non-opioid related intractable constipation;
* Patients with mental disorder;
* Creatinine clearance rate \<15mL/min;
* ALT or AST ≥ 10 fold of upper limit of normal value

Primary outcomes:
measure: Change in medication adherence
timeFrame: Change from baseline at 1 month after discharge
Secondary outcomes:
measure: Change in pain score
timeFrame: Change from baseline at 1 month after discharge
measure: Change in quality of life
timeFrame: Change from baseline at 1 month after discharge
measure: Change in patients' knowledge of cancer pain and analgesics
timeFrame: Change from baseline at 1 month after discharge
measure: Incidence of adverse events [safety and tolerability]
timeFrame: Up to 1 month after discharge
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Ping Huang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng X, Ding H, Xu S, Xie R, Liu Y, Zhai Q, Fang L, Tong Y, Sun J, Xin W, Wu N, Chen J, Shi W, Yang L, Li H, Shao J, Wang Y, Yu H, Zhang B, Du Q, Yang Y, Zhang X, Duan C, Zhao Q, Shi J, Huang J, Fan Q, Cheng H, Chen L, Kong S, Zhang H, Gong L, Zhang Y, Song Z, Yang Y, Zhou S, Huang C, Lin J, Wang C, Huang X, Wei Q, Sun Y, Huang P. Pharmacist-Led Management Improves Treatment Adherence and Quality of Life in Opioid-Tolerant Patients With Cancer Pain: A Randomized Controlled Trial. Pain Ther. 2022 Mar;11(1):241-252. doi: 10.1007/s40122-021-00342-0. Epub 2022 Jan 29.
Clinical trial NCT03855423: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer
Official title: Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Keywords: MTD
TRF
Pharmacology
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Malaysia Palm Oil Board
First posted: 2019-02-26
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm intervention study 3+3 step up design
Primary purpose: OTHER

Brief summary: Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal tolerated dose: MTD) that can be used in women with breast cancer.

Detailed description: 3+3 step up design method will be used in this study.

Eligibility criteria: Inclusion Criteria:

* Patients with operable breast cancer
* Life expectancy of at least 3 months
* Adequate organ function
* No allergy to Vitamin E and TRF
* Provides consent to participate in trial and adhere to the study protocol

Exclusion Criteria:

* Receiving concomitant chemotherapy, radiotherapy, hormonal, immune therapy or other investigational drugs
* Uncontrolled concurrent illness
* Pregnant / breast feeding women
* Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications

Primary outcomes:
measure: Physical Assessment
timeFrame: For 2 to 4 weeks during supplementation
measure: Liver Function Test
timeFrame: For 2 to 4 weeks during supplementation
Secondary outcomes:
measure: Bioavailability of TRF
timeFrame: For 2 to 4 weeks during supplementation
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Center
Study officials:
affiliation: University of Malaya
name: Nur Aishah Taib, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05696223: Doppler at the Diagnosis in Predicting Perinatal Outcomes in Early and Late-onset Fetal Growth Restriction
Official title: Doppler at the Diagnosis in Predicting Perinatal Outcomes in Early and Late-onset Fetal Growth Restriction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Retardation
Keywords: Fetal Growth Retardation, Doppler, perinatale outcome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the FGR of antenatal diagnosis, who were confirmed by an ultrasound made by a referring Doctor and involved in a specific management for FGR, during this period of 2 years were included

Brief summary: When a FGR is diagnose, the challenge in his monitoring is to assess the benefit-risk balance between continuing the pregnancy in order to limit complications related to prematurity and birth in order to minimize any risk of fetal death in utero. By able to know the characteristics of fetal deteriorations and its relationship with fetal and neonatal outcomes could be a thankful help in this decision. The placental insufficiency is by far the most common cause of FGR (32)(miller 2008). This effect can be documented thanks to ultrasound examinations to study fetal growth and Doppler of umbilical arteries for the placenta, the middle cerebral artery for the brain perfusion and the Ductus Venosus for the cardiac effects of placental dysfunction. The apparition of Doppler abnormalities suggests a deterioration of the disease and leads to several changes in clinical FGR management. Nevertheless, at this time, very few studies allow us to predict the time util the degradation and their impact on perinatal outcomes.

The primary aim of this study was to evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies. The secondary aim was to evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies


Eligibility criteria: Inclusion Criteria:

* Fetal growth restriction of antenatal diagnosis

Exclusion Criteria:

* Twin pregnancies, non-isolated IUGR, post-natal diagnosis of FGR and incomplete records

Primary outcomes:
measure: evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies
timeFrame: during pregnancy (6 month per patient maximum)
Secondary outcomes:
measure: evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies
timeFrame: during pregnancy (6 month per patient maximum)
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale et Universitaire de Nancy
state: Meurthe-et-moselle
Study officials:
References: