louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04855955: Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
Official title: Individual Patient Expanded Access Investigation New Drug (IND) Application for Administration of Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Alzheimer Disease
Keywords: Autologous Adipose-derived Stem Cells (AdMSCs)
Lead sponsor: Celltex Therapeutics Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-22
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life.


Eligibility criteria: Inclusion Criteria:

* The patient is diagnosed with later stage of Alzheimer Disease with sever cognitive disability.
* All current anti-Alzheimer medicines cannot prevent disease progression and the patient's mental and physical ability persistently declined
* Patient's legal guardian and caregiver must voluntarily sign an approved written consent form after ample explanation of the proposed therapy.

Exclusion Criteria:

* Current diagnosis of malignancy
* Renal/liver dysfunction: Exceed two times as normal subject
* Pregnant or nursing
* Received other trial drugs within 30 days after participation of this study
* Experienced major surgery or trauma in the last 14 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Little Alsace Urgent Care Center
name: Richard L Neel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01650155: Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.
Official title: Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any deviation from healthy conditions

Primary outcomes:
measure: number (% subjects) with drug-related AEs.
timeFrame: day -21 to day 95
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: day 1 to day 90
measure: AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: day 1 to day 90
measure: AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose)
timeFrame: day 1 to day 90
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1294.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00844155: Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit
Official title: A Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir (Tamiflu®) in Patients in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Influenza A Virus Infection
Influenza B Virus Infection
Keywords: Prevention or treatment of influenza in ventilated patients
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2009-02-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This proposed pharmacokinetic study will test the hypothesis that in critically ill patients with respiratory failure requiring mechanical ventilation such as might be anticipated to be needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults ill with influenza in whom oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this experiment will test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and urinary recovery of drug from 0 to 48 hrs after administration.

Detailed description: Not required

Eligibility criteria: Inclusion Criteria:

* patients admitted to the Intensive Care Unit requiring mechanical ventilation due to respiratory failure
* must be within the ages of 18-75 yrs

Exclusion Criteria:

* patients unable to have enteral feeding
* intolerance to oseltamivir
* pregnancy
* gastrointestinal or malabsorptive disease
* intestinal bypass surgery
* diarrhea (\>2 loose bowel movements per day)
* receipt of prokinetic medications (metoclopramide, domperidone, erythromycin)
* severe liver disease (hepatocellular enzymes \> 3 times the upper limit of normal)
* renal failure (Cockroft-Gault Creatinine Clearance \< 30 ml/min, Dialysis dependant)
* cystic fibrosis
* intoxication or drug overdose

Primary outcomes:
measure: Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults .
timeFrame: 13 months
Secondary outcomes:
measure: Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability.
timeFrame: 13 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Faisal Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06889155: Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery .
Official title: Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery in Low Risk Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Blood Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

Detailed description: Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 40 years
* singleton full term pregnancy.
* Candidate for elective cesarean delivery under spinal anaesthesia

Exclusion Criteria:

* women at high risk for intraoperative bleeding as those with placenta previa or other placental abnormalities
* women with bleeding or coagulation disorders.
* Medical disorder associating pregnancy as preeclampsia or diabetes
* Allergy or contraindications to oxytocin
* Fetal macrosomia, or congenital anomalies
* Polyhydramnios
* Uterine abnormalities as fibroids
* Women with intraoperative complications as vascular or visceral injuries

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: during cesarean delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Armed force faculty of medicine
Study officials:
affiliation: Cairo University
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05304455: Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection
Official title: Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Splenectomy
Venous Thrombosis
Hypertension, Portal
Keywords: Cirrhosis
Venous thrombosis
Portal Hypertension
Apixaban
Splenectomy
Laparoscopy
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Apixaban is effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection

Detailed description: After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, and be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. The Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients at baseline, on postoperative months (POD) 7, at postoperative months (POM) 1, 3, and 6. All groups will receive the therapy for six months irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then six months monitoring will be done as per the primary outcome.

Eligibility criteria: Inclusion Criteria:

1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
2. Splenomegaly with secondary hypersplenism
3. Bleeding portal hypertension
4. No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
5. Informed consent to participate in the study

Exclusion Criteria:

1. Hepatocellular carcinoma or any other malignancy,
2. Hypercoagulable state other than the liver disease related
3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
4. Child - Pugh C
5. Recent peptic ulcer disease
6. History of Hemorrhagic stroke
7. Pregnancy.
8. Uncontrolled Hypertension
9. Human immunodeficiency virus (HIV) infection

Primary outcomes:
measure: Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of participants with Splenic vein thrombosis
timeFrame: 6 months
measure: Proportion of participants with Mesenteric vein thrombosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College, Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College, Yangzhou University
name: Ping Chen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05736055: Validation Of Cambodia Version of Five Minutes Hearing Test
Official title: Validation Of Cambodia Version of Five Minutes Hearing Test to Screening Hearing Loss
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hearing Loss
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Cambodian patients complained about hearing problems. They undergo check with audiometry in Preah Ang Duong Hospital, Phanom Penh, Cambodia

Brief summary: Seek the simple tool as questionnaire for screening hearing loss. The FMHT was developed by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). It is a standard hearing questionnaire. So, we plan to translate the FMHT into Cambodian language and validate by comparing its result with those of audiometry.

Detailed description: Primary Objective:

To assess sensitivity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

Secondary Objective: To assess

1. Specificity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
2. Likelihood ratio of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
3. Predictive value of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

Eligibility criteria: Inclusion Criteria:

* Age 18-60 years old
* Able to read and understand Khmer language
* Volunteer to participated

Exclusion Criteria:

* Aphasia patients
* Patients with severe mental disability
* Patients with other conditions that preclude audiometry

Primary outcomes:
measure: sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT))
timeFrame: 2 years
Secondary outcomes:
measure: specificity of the questionnnaire (FMHT in Cambodia version (CAM-FMHT))
timeFrame: 2 years
measure: likelihood ratio of the questionnaire (FMHT in Cambodia version (CAM-FMHT))
timeFrame: 2 years
measure: predictive value of the questionnaire (FMHT in Cambodia version (CAM-FMHT))
timeFrame: 2 years
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Preah Ang Duong Hospital
Study officials:
affiliation: Khon Kaen University
name: Dawin Rotha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00877955: Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation
Official title: Open-label, Randomized, Single-dose, 2-way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: bioequivalence
pharmacokinetic
alprazolam
sublingual
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects
* BMI 17.5 - 30.5
* Must provide informed consent

Exclusion Criteria:

* Clinically significant disease
* Narrow angle glaucoma
* Positive drug screen

Primary outcomes:
measure: Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
timeFrame: 11 days
Secondary outcomes:
measure: Alprazolam time of maximum concentration (Tmax) and half life
timeFrame: 11 days
measure: Adverse events, clinical laboratory tests, vital signs
timeFrame: 11 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06714955: Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects
Official title: A Phase 1, Double-Blind, Parallel-arm, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection Administered Subcutaneously in Non-diabetic Overweight or Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non-diabetic Overweight or Obese
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 30
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 is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) meeting one of the following requirements:

  1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
  2. Between ≥ 27.0 kg/m2 and \< 30.0 kg/m2 (overweight) with at least 1 of the following: 1) One or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) Weight-bearing joint pain; 3) Obesity causing dyspnea or obstructive sleep apnea syndrome
* Have a stable body weight (\<5% self-reported change during the previous 8 weeks) before screening
* Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.

Exclusion Criteria:

* Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists, or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
* Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
* Have received drugs that have an impact on body weight within 12 weeks before screening.
* Surgical treatment for obesity.
* Known type I/II diabetes.
* History of acute or chronic pancreatitis or pancreatic injury.
* History of drug abuse or alcoholism at screening.

Primary outcomes:
measure: Number of treatment adverse events
timeFrame: 10 weeks
Secondary outcomes:
measure: Pharmacokinetic endpoint: Concentration of BGM0504 in plasma
timeFrame: 10 weeks
measure: Change in fasting weight at week 10
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC, Inc
state: Maryland
Study officials:
References:
Clinical trial NCT06096155: Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
Official title: Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthropathy
Keywords: Total Hip Prosthesis Revision
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 61
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: Adult subjects who needed a revision of total hip arthroplasty, implanted with a SAGITTA EVL-R revision femoral stem according to instructions for use, over a period of time between 31/01/2010 and 31/12/2015.

Brief summary: This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF.

This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.

The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems.

Secondary objectives are to :

* study long term patient satisfaction with their hip prosthesis,
* confirm the long-term safety of these implants by studying the possible complications observed,
* evaluate the performance of these implants using clinical scores.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old at the time of surgery,
* Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2010 and 31/12/2015,
* Affiliated to French health insurance system

Exclusion Criteria:

* Patient who has rejected to the use of his/her personal data,
* Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.

Primary outcomes:
measure: Survival rate at mid/long term follow-up
timeFrame: At 7/10 years after surgery
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: At 7/10 years after surgery
measure: Adverse events
timeFrame: At 7/10 years after surgery
measure: Oblivion of prosthesis
timeFrame: At 7/10 years after surgery
measure: Pain release
timeFrame: At 7/10 years after surgery
measure: Functional improvement
timeFrame: At 7/10 years after surgery
Other outcomes:
Locations:
city: Challans
country: France
facility: Centre Hospitalier Loire Vendée Océan
state: Vendée
Study officials:
References: