louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02170207: Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]
Official title: Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stress Ulcer and Acute Gastric Mucosal Lesions
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute stress ulcer and acute gastric mucosal lesions

Brief summary: The purpose of this survey is to evaluate the safety (that is, frequency of adverse events) and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.

Detailed description: This survey was designed to evaluate the safety (that is, frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 mg (Takepron Intravenous 30 mg) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.

For adults, 30 mg of lansoprazole is typically mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

Participants with the following diseases for whom oral administration is not feasible:

Acute stress ulcer, and acute gastric mucosal lesions (both of which should be accompanied by bleeding).

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to Week 9
Secondary outcomes:
measure: Percentage of Participants With Observed Hemostatic Effect
timeFrame: Baseline up to Week 9
measure: Percentage of Participants With Confirmed Hemostatic Effect
timeFrame: Baseline up to Week 9
measure: Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment
timeFrame: Baseline up to Week 9
measure: Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
timeFrame: Week 17 (8 weeks after the last dose of study drug)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT03731507: KinectROM Application for Assessing Range of Motion in Upper and Lower Extremity: A Development and Validation Study
Official title: KinectROM Application for Assessing Range of Motion in Upper and Lower Extremity: A Development and Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Range of Motion
Keywords: range of motion
upper extremity
lower extremity
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to investigate the validity and reliability of KinectROM application for objectively evaluating range of motion (ROM)

Detailed description: The application KinectROM called has been developed for assessing ROM with Kinect controller by our team. So, shoulder, elbow, knee, hip and ankle ROM measurements will be made with universal goniometer and developed KinectROM application.

Eligibility criteria: inclusion Criteria: -Healthy individuals with 18-40 years

Exclusion Criteria:

-Have any limited extremity between the ages of 18-40 years.

Primary outcomes:
measure: Range of Motion
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
Clinical trial NCT01758107: Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Official title: Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Transplant
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.

Detailed description: Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8.

The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year

Exclusion Criteria:

* history of acute rejection, or subclinical rejection

Primary outcomes:
measure: longterm glomerular filtration rate defined by eGFR CKD-EPI
timeFrame: 5 years
Secondary outcomes:
measure: Acute rejection rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
References:
Clinical trial NCT03184207: A Systematic Echography During Intubation Procedure to Predict Cardiovascular Collapse
Official title: A Systematic Ultrasound Assessment During Intubation Procedure to Predict Cardiovascular Collapse Related to Intubation in the Intensive Care Unit: a Prospective, Multiple-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 70
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: Patient admitted to ICU

Brief summary: In the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily available in most ICUs for several years. Echocardiography enables to perform a noninvasive hemodynamic evaluation (cardiac function and volemia status).

We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse and its components.


Eligibility criteria: Inclusion Criteria:

Patient requiring endotracheal intubation

Exclusion Criteria:

* Age \< 18 yrs
* Pregnancy
* Amputation of a lower limb
* Passing leg raising contraindication: intracranial hypertension with invasive monitoring, fracture of the pelvis or limbs
* Patients under administrative protective measures
* Severe cardiovascular collapse before intubation
* Severe cardiogenic pulmonary oedema

Primary outcomes:
measure: Subsequent cardiovascular collapse related to intubation
timeFrame: Within 15 minutes of intubation
Secondary outcomes:
measure: Ultrasound parameters to predict fluid responsiveness
timeFrame: 30 minutes before intubation, less than 30 minutes after intubation, 1 minutes after lifting legs and 3 hours after intubation
Other outcomes:
Locations:
city: Brest
country: France
facility: Hôpital d'Instruction des Armées Clermont Tonnerre
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: Centre Hospitalier des Pays de Morlaix
Study officials:
affiliation: CHRU Brest Hospital Brittany Occidental University
name: JEAN-MICHEL Vanessa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.
Clinical trial NCT05000307: Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection
Official title: Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV Infection
Immune System Disorder
Keywords: immunology
SARS-CoV2
Antibodies
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: (serial) blood samples in patients with proven SARS-CoV2
Primary purpose: BASIC_SCIENCE

Brief summary: In light of the current coronavirus disease 2019 (COVID-19) pandemic, the investigators want to better study the immunological characteristics of Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) infections in adults. The investigators invite volunteers to participate in a clinical study to better understand what happens after an infection with SARS-CoV2. By collecting and analysing blood samples of people that were infected, the investigators want to evaluate whether or not the participants had an adaptive immune response with the producting of immunoglobulin. The investigators will evaluate the quality of the antibodies and their neutralising capacity. In a selected patient group with strong antibody response, the investigators will try to reproduce them in the lab after the collection of a larger blood sample (max 72 mL) of, in case of insufficient B-cells, a leucapheresis (after consent of the patient). These antibodies can be used in clinical trials to evaluate whether the investigators can cure patients faster or prevent disease by the utilisation of these antibodies.

Aside from the aforementioned information the investigators will also collect clinical data such as: demographic information, medical history, routine lab results, radiographic imaging and medication use.

After the completion of the study, the samples will be stored for 30 years with consent of the participants.


Eligibility criteria: Inclusion Criteria:

* Evidence of prior COVID-19 infection, documented by polymerase chain reaction (PCR) or antibody testing (IgG based)

Exclusion Criteria:

* Known pregnancy at the time of screening
* Patient is on immunosuppressive therapy or was treated with immunosuppressive therapy during the last 6 months
* Inability to give informed consent or absence of legal representative who can give informed consent.

Primary outcomes:
measure: Neutralising capacity of naturally produced antibodies against SARS-CoV2
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
Study officials:
affiliation: PI
name: Linos Vandekerckhove, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00380107: Volume Deficit Prior to Surgery
Official title: Estimation of Volume Deficit in Patients Prior to Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Surgery
Keywords: Minor surgery
Volume optimization
Volume deficit
Epidural anesthesia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-09-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for surgery in 3 procedures:

* mastectomy
* rad. prostatectomy
* open adb. surgery

And 20 healthy subjects

Brief summary: It is the purpose of the researchers to identify the variation in intravascular deficits which can have relevance in high risk patients for minor and medium sized surgery.

The investigators will also estimate fluid deficit in healthy, non-fasting subjects for comparison.

Detailed description: Intravascular volume optimization has shown to improve outcome after surgery. In minor and medium surgery , however, the preoperative volume deficit has not been estimated with functional parameters. Patient scheduled for minor surgery are included. After the patient is anesthetized the intravascular volume is optimized by stroke volume maximization by colloid boluses. Stroke volume is obtained by esophageal Doppler technique which is a minimally invasive method.

The volume estimated for optimization is considered as the functional volume deficit.

In the healthy subjects the probe will be placed in the awake subject. A standardized meal and fluid intake secures that the subjects are in a non-fasting state.

Eligibility criteria: Inclusion Criteria:

* Planned minor or medium sized surgery

Exclusion Criteria:

* Oesophageal pathology
* Age \>90 yr or \< 18 yr
* Alcohol abuse,
* Insulin dependent DM

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, ABD centret, anaesthesiological dept. 2041
Study officials:
affiliation: Rigshospitalet, Denmark
name: Morten Bundgaard-Nielsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bundgaard-Nielsen M, Jorgensen CC, Kehlet H, Secher NH. Normovolemia defined according to cardiac stroke volume in healthy supine humans. Clin Physiol Funct Imaging. 2010 Sep;30(5):318-322. doi: 10.1111/j.1475-097X.2010.00944.x. Epub 2010 Jun 10.
Clinical trial NCT05088707: Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage
Official title: Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Miscarriage
Keywords: miscarriage
sublingual
vaginal
misoprostol
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: an open-label randomized controlled study
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage

Detailed description: In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.

Eligibility criteria: Inclusion Criteria:

* All women above 18 years of age
* between 13-26 weeks of gestation.
* Pregnancy is confirmed by a pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
* respiratory illnesses, recent liver disease, or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* -Failed medical or surgical evacuation before the presentation.
* Known allergy to misoprostol.

Primary outcomes:
measure: Completeness of abortion
timeFrame: 7 days
Secondary outcomes:
measure: Successful medical abortion
timeFrame: 7 days
measure: Bleeding pattern following treatment
timeFrame: 7 days
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT03221907: Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' in Peripheral Neuropathic Pain
Official title: A Multi-center, Randomized, Double-blind, Parallel, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain of Mononeuropathy
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-19
Enrollment: 352
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral neuropathic pain


Eligibility criteria: Inclusion Criteria:

* both male and female who are over 19-year-old
* patient whose pain scale is 4\~9
* patient who has pain of mononeuropathy

Exclusion Criteria:

* patient whose CCr is \<60ml/min
* patient who has other pain which is not from mononeuropathy
* patient who is going to have an operation during this study
* patient who has abnormal ECG

Primary outcomes:
measure: Daily Pain Rating Scale
timeFrame: 12-week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee MK, Jeon Y, Choi SS, Lee PB, Kim YC, Suh JH, Sim SE, Song SO, Ko Y, Yu JM, Min K, Lee JH. Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial. Clin Ther. 2020 Dec;42(12):2266-2279. doi: 10.1016/j.clinthera.2020.10.009. Epub 2020 Nov 30.
Clinical trial NCT02848807: Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
Official title: Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Toxicity Due to Chemotherapy
Cancer Cachexia
Metastatic Colorectal Cancer
Quality of Life
Dietary Modification
Lead sponsor: University Clinical Centre, Gdansk
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
First posted: 2016-07-29
Enrollment: 100
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: Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.

Detailed description: Other endpoints:

* to determine whether high protein ONS influence on the nutritional status
* to determine whether high protein ONS influence on the quality of life
* to determine whether high protein ONS influence on the performance status
* to determine high protein ONS tolerability / ONS intake compliance

Eligibility criteria: Inclusion Criteria:

* histological confirmed diagnosis of CRC in clinical stage IV
* successful qualification to chemotherapy
* performance status at least 80% according to Karnofsky scale and \<2 according to WHO/ECOG scale
* cancer-related asymptomatic precachexia diagnosed
* absence of contraindications to oral nutrition and practicable realization of oral nutrition
* absence of severe, decompensated concomitant diseases
* signed informed consent for the participation in the study

Exclusion Criteria:

* diagnosis of a malignant neoplasm in clinical stage I-III
* disqualification from oncologic treatment
* cancer cachexia or cancer anorexia-cachexia syndrome
* poor performance status
* contraindications to oral nutrition or to high protein nutrition
* regular nutritional support at the moment of qualification to the study
* patient incompliance at the moment of qualification to the study

Primary outcomes:
measure: Chemotherapy-related toxicity during 12th week of observation
timeFrame: at baseline and after 12th week
Secondary outcomes:
measure: Changes in the Nutritional status / metabolic status
timeFrame: at baseline and after 12th week
measure: Changes in the Quality of life and patients well-being
timeFrame: at baseline and after 12th week
measure: Changes in the Performance status
timeFrame: at baseline and after 12th week
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: University Clinical Centre
Study officials:
affiliation: University Clinical Centre, Gdansk, Poland
name: Sylwia Malgorzewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01875107: Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
Official title: Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hyperglycemia in Pregnant Diabetic Patients
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control.

Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help maintain euglycemia for pregnant patients with gestational and preexisting diabetes after steroid administration, and possibly impact length of hospital admission.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota
2. Must be 18 years or older
3. Must speak English, Spanish, or Somali
4. Patients must receive steroids for fetal lung maturity as part of their hospital course

Exclusion Criteria:

1. Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease
2. Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy

Primary outcomes:
measure: Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.
timeFrame: number of hospital days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Shelly H Tien,, M.D
role: PRINCIPAL_INVESTIGATOR
References: