louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00400283: A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes
Official title: A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-11-16
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Diet treatment only for at least two weeks
* Body mass index (BMI) between 22-34 kg/m2 inclusive
* HbA1C between 6.5-12.0% inclusive
* Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive
* Patients should be negative (lesser than 70 kU/l) for antibodies against glutamic acid decarboxylase (GAD)

Exclusion Criteria:

* Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels
* History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator
* Impaired renal function, serum creatinine greater than 150µmol/L
* Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies
* Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing
* Patients, who had donated plasma or blood in the past month, or in excess of 500 mL in the past 12 weeks
* Patients who had a significant history of alcoholism or drug/chemical abuse

Primary outcomes:
measure: To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04162483: Safety and Performance of the Neuroform Atlas™ Stent System
Official title: Safety and Performance of the Neuroform Atlas™ Stent System in Patients Requiring Stent Assisted Intracranial Aneurysm Treatment in France - A National, Retrospective Multi-center Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects treated in one of the French Sites participating to the registry and who have been treated with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 01 February 2017 and 01 March 2018.

Brief summary: The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.

Detailed description: This proposed ATLAS FR study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in France between 01 February 2017 and 01 March 2018.

This will provide a comprehensive data set that is specifically representative of the Atlas stent use in France.

Eligibility criteria: Inclusion Criteria:

* Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2 018.
* Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data

Primary outcomes:
measure: permanent morbidity and mortality rate
timeFrame: up to 12-16 months post-procedure
Secondary outcomes:
measure: AEs and device malfunctions
timeFrame: peri-procedure
measure: Efficacy Endpoint with mRS
timeFrame: immediately post-procedure and at 12-16 months post procedure
measure: Retreatment
timeFrame: up to 12-16 months
measure: Subarachnoid hemorrhage (SAH)
timeFrame: Up to 12-16 months
measure: Aneurysm rupture/re-rupture
timeFrame: Up to 12-16 months
measure: SAEs resulting in neurological death
timeFrame: Up to 12-16 months
measure: device-related SAEs
timeFrame: Up to 12-16 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Gui de Chauliac
Study officials:
affiliation: Hopital Lariboisière
name: Emmanuel Houdart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05553483: Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis
Official title: Comparing the Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammatory Status/Markers in Children With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allergic rhinitis (AR) represents one of the most common global health problems with seriously increasing incidence over the last decades.The goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. Acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling patients.

Detailed description: Sixty Egyptian children with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-children group will receive 2-session per-week laser stimulation for 6 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for six weeks), the second group will receive 2-session per-week laser stimulation for six weeks to some bilateral selected acupoints. the stimulated points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

Eligibility criteria: Inclusion Criteria:

* allergic rhinitis children
* physician-based diagnosis of allergic rhinitis

Exclusion Criteria:

* children with intellectual disabilities
* chest disease or heart disease or local congenital nose deformities
* participants received within-previous-six-months self-prescribed or by-therapist prescribed complementary therapies

Primary outcomes:
measure: erothrocyte sidemention rate
timeFrame: It will be measured after 6 weeks
Secondary outcomes:
measure: Immunoglobulin E
timeFrame: It will be measured after 6 weeks
measure: interleukin 1-beta
timeFrame: It will be measured after 6 weeks
measure: C-reactive protein
timeFrame: It will be measured after 6 weeks
measure: total eosinophil count
timeFrame: It will be measured after 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06043583: Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis
Official title: Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenomyosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 56
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.

Detailed description: Screening

* History, Physical examination
* Laboratory test (Hemoglobin) / MRI
* Pictorial blood loss assessment chart
* Symptom/Quality of life score

Intervention

* Intrauterine device or uterine artery embolization
* Adverse event montoring

Follow-up visit #1 (1 month)

* Vital signs
* blood test (Hemoglobin) / Ultrasound
* Adverse event monitoring

Follow-up visit #2 (3 month)

• MRI only for embolization patients

Follow-up visit #3 (6 months)

* Blood test (Hemoglobin) / Ultrasound
* Pictorial blood loss assessment chart
* Symptom/Quality of life score

Follow-up visit #4 (12months)

* Blood test (Hemoglobin) / Ultrasound
* Pictorial blood loss assessment chart
* Symptom/Quality of life score

Eligibility criteria: Inclusion Criteria:

1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin \< 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea)

Exclusion Criteria:

1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet \< 50,000 or INR \> 1.5) 4. Concomitant endometriosis 5. Pregnancy

Primary outcomes:
measure: Hemoglobin level
timeFrame: Hemoglobin level at 6 and 12 months after each procedure
Secondary outcomes:
measure: Pictorial blood loss assessment chart (PBAC)
timeFrame: 0,6,12 months
measure: Visual analogue scale
timeFrame: 0,6,12 months
measure: Symptom and quality of life score questionnaire
timeFrame: 0,6,12 months
measure: Uterine volume
timeFrame: 0,12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT02572583: A Clinical Study of Treating Influenza With Liugan Shuangjie Heji
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Reconciling Exterior and Interior Therapy
Influenza
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. A total of 300 cases of seasonal flu in Beijing is to be collected, and divided into one treatment group and two control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of treating influenza with the reconciling therapy based on the following outcome measures: the time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it takes for the body temperature to return to normal.


Eligibility criteria: Inclusion Criteria:

1. The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza;
2. All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior;
3. The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher;
4. Aged between 18 to 65 years;
5. Voluntary and signed informed consent.

Exclusion Criteria:

1. The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs;
2. Routine blood WBC is greater than the upper limit of normal;
3. Chest X-ray examination with inflammatory exudation images;
4. With cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal;
5. Pregnancy, nursing mothers, and allergic constitution;
6. Participated in clinical subjects for nearly three months.

Primary outcomes:
measure: time from the medicine intake to 0.5℃ drop of body temperature
timeFrame: five days
measure: time for the body temperature to return to normal
timeFrame: five days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongfang Hospital affiliated to Beijing University of Chinese Medicine
Study officials:
affiliation: Dongfang Hospital Beijing University of Chinese Medicine
name: Yang - Jiao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01484483: An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya
Official title: Breast Cancer Care (BRECC) Registry - Development of a Breast Cancer Registry to Determine the Magnitude of Breast Cancer and Current Clinical Care Patterns in Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 400
Sex: FEMALE
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: Newly diagnosed breast cancer patients

Brief summary: This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer
* No previous interventional therapy for breast cancer
* Ability to provide written informed consent as per GCP and local regulations

Exclusion Criteria:

* Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment
* Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse

Primary outcomes:
measure: Incidence of breast cancer in Kenya
timeFrame: 5 years
measure: Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Patient demographics of breast cancer patients in Kenya
timeFrame: 5 years
measure: Pathology: Prevalence of tumour types
timeFrame: 5 years
measure: Correlation between risk factors and clinical outcome
timeFrame: 5 years
measure: Therapy duration/compliance
timeFrame: 5 years
measure: Safety: Incidence of adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: University of Nairobi School of Medicine; Internal Medicine and Therapeutics
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06290583: Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section
Official title: Comparison Between the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.


Eligibility criteria: Inclusion Criteria:

* Pregnant \>36 weeks singleton baby
* American Society of Anesthesiologists (ASA) physical status 2
* Age : between 18 years old and 35 years old

Exclusion Criteria:

* Pregnant women with cardiac disease and history of psychiatric illness
* Pregnant women who received spinal anesthesia and converted to general anesthesia
* Women who have sensitivity to local anesthetics,
* Women who have Eclampsia, abruption placenta or placenta previa
* Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia

Primary outcomes:
measure: Maternal arterial blood pressure
timeFrame: at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 hours
Secondary outcomes:
measure: Evaluation of duration of motor block
timeFrame: will be assessed before skin incision and every 15 min intervals until the end of surgery and then at 30-min intervals until its complete regression
measure: Total dose of ephedrine
timeFrame: From beginning of administration of spinal anesthesia until complete regression of motor blockade
Other outcomes:
Locations:
city: Qena
country: Egypt
facility: South Valley University
Study officials:
affiliation: Lecturer in anesthesiology, intensive care and pain management, South Valley University
name: Mohamed G Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02217683: Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion
Official title: Pulmonary Hemodynamic Effects of Stored Red Blood Cell Transfusion in Post-Operative Cardiac Surgical Patients: Influence of Breathing Nitric Oxide. A Randomized Controlled Trial in the Cardiac-Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Hemolysis
Keywords: Catheterization, Swan-Ganz
Cardiac Surgical Procedures
Blood Transfusion
Nitric Oxide
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 0
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 objective of this study is to assess if prolonged storage time of a packed red blood cell unit may cause pulmonary vasoconstriction after transfusion, in a susceptible population such as cardiac surgery patients. The investigators will also evaluate the potential reversal effect of Inhaled Nitric Oxide on pulmonary vasoconstriction induced by stored blood transfusions.

Detailed description: Patients will be randomized into one of the three groups:

I. Blood transfusion stored for less than 10 days II. Blood transfusion stored for more than 30 days III. Blood transfusion stored for more than 30 days days plus inhalation of Nitric Oxide at 80 part per million for an hour during blood transfusion.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Elective cardiac or aortic surgery
3. One or more blood transfusions scheduled for clinical reasons
4. Presence of an arterial catheter and pulmonary arterial catheter

Exclusion Criteria:

1. Emergent cardiac surgery.
2. Patients requiring irradiated or washed blood transfusions.

Primary outcomes:
measure: Pulmonary vascular resistance index
timeFrame: During and after blood transfusion- average time of observation 6 hours
Secondary outcomes:
measure: Hemolysis
timeFrame: During and after blood transfusion- average time of observation 6 hours
measure: Nitric oxide metabolites
timeFrame: During and after blood transfusion- average time of observation 6 hours
measure: Inflammation
timeFrame: During and after blood transfusion- average time of observation 6 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lorenzo Berra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berra L, Pinciroli R, Stowell CP, Wang L, Yu B, Fernandez BO, Feelisch M, Mietto C, Hod EA, Chipman D, Scherrer-Crosbie M, Bloch KD, Zapol WM. Autologous transfusion of stored red blood cells increases pulmonary artery pressure. Am J Respir Crit Care Med. 2014 Oct 1;190(7):800-7. doi: 10.1164/rccm.201405-0850OC.
Clinical trial NCT01138683: Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
Official title: Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Decompensated Heart Failure
Keywords: Acute decompensated heart failure
ultrafiltration
diuretics
AKI
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 1
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 CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Severe systolic heart failure with ejection fraction \<40%
* And Hospitalisation for decompensated heart failure
* And New York Heart Association (NYHA) III or IV
* And 1 of the following:

  * Jugular vein distension\>6cm
  * Tissue Doppler mitral annulus lateral\>12 or medial\>15
  * Chest X-ray: pulmonary edema or pleural effusion

Exclusion Criteria:

* Need for inotropic or vasopressive agents
* Use of intravenous (IV) contrast media
* Acute coronary syndrome
* Need of dialysis
* Severe co-morbidity
* Contra-indications for anticoagulation
* Pregnancy

Primary outcomes:
measure: Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics
timeFrame: at 6 months
Secondary outcomes:
measure: determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration.
timeFrame: at 48h after treatment start
measure: Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure
timeFrame: at 6 months
measure: Kidney function measured by creatinine
timeFrame: after 28 days and 6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Sofie Gevaert, MD
role: PRINCIPAL_INVESTIGATOR
References: