louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01136811: Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures
Official title: Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lower Extremity Occlusive Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Louis A. Weiss Memorial Hospital
First posted: 2010-06-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although the daVinci Surgical System is FDA approved and widely used for surgical procedures for urology, cardiac, general, and gynecologic procedures, it is not currently approved specifically for use in vascular surgery and the FDA has required the PI to conduct a small feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.


Eligibility criteria: Inclusion Criteria:

* Patients with significant femoropopliteal or tibial occlusive disease not amenable to catheter directed therapy (ie angioplasty/stenting). Symptoms include lifestyle-limiting claudication, rest pain and/or tissue loss.
* Patients with an ABI between 0.2 and 0.8.
* Femoropopliteal disease visible on color duplex ultrasound (DUS)
* Patent and minimally diseased common femoral and proximal superficial artery
* Patients with American Society of Anesthesiology (ASA) I, II or III classification
* PT/PTT, EKG, HbA1c, liver function, within normal ranges within 30 days prior to procedure or stable over the last 6 months.

Current University of Chicago Medical Center Lab standards will be used. Pulmonary function will be assessed as needed by preoperative anesthesia evaluation. (Generally for infrainguinal procedures, pulmonary function is not assessed)

* Body Mass Index (BMI) \<40

Exclusion Criteria:

* Previous surgery in the inguinal region (ie: prior femoral artery dissection)
* Myocardial infarction (MI) within the last 6 months
* Laboratory evidence of hypercoagulable state and/or connective tissue disease
* Pregnant women
* History of non-compliance with medical care

Primary outcomes:
measure: Patency of Graft Anastomosis
timeFrame: 30 Day
Secondary outcomes:
measure: Time for Femoral Artery Dissection and Anastomosis
timeFrame: 1 day
measure: Improvement in ABI Measurement of 0.15 or Better
timeFrame: 3 month, 6 month, 1 year
measure: Death
timeFrame: 30day, 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Weiss Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT00850811: A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
Official title: A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Keywords: Peplin
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.


Eligibility criteria: Inclusion Criteria:

* healthy males or females;
* in the case of females of childbearing potential, must be using effective contraception and must provide a negative pregnancy test;
* must read, understand and provide signed informed consent.

Exclusion Criteria:

* are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
* are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
* are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
* have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.

Primary outcomes:
measure: To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
affiliation: TKL Research
name: Jonothan S Dosik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.
Clinical trial NCT02001311: Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment
Official title: Effect of Chlorhexidine Gel on Bacterial Count and Orthodontic Brackets During Fixed Orthodontic Treatment; In-vivo & In-vitro Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Orthodontic Appliance Complication
Dental Caries
Keywords: chlorhexidine gel
orthodontic brackets
orthodontic patients
bacterial count
friction
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in orthodontic patient to reduce caries risk and the possible consequential effect of this use on the orthodontic brackets used for the treatment.

The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic brackets.


Eligibility criteria: Inclusion Criteria:

* Patients' age range from 18-30 years.
* Fixed orthodontic treatment.
* All the patients are at the end of leveling and alignment stage.
* Initial bacterial count indicates high caries risk.
* All patients will be given good oral hygiene instruction at the first visit.
* The subjects had not taken antibiotics for at least 6 weeks before saliva sampling or during the experimental period.
* All subjects used a fluoride dentifrice twice a day.

Exclusion Criteria:

* Patients' age more or less then the age range specified.
* Removable orthodontic treatment.
* Patients at early stages of leveling and alignment.
* Initial bacterial count indicates low caries risk.
* Subjects that have taken antibiotics for at least 6 weeks before saliva sampling.

Primary outcomes:
measure: mutants streptococcus count
timeFrame: 48 hours
Secondary outcomes:
measure: friction
timeFrame: 2 minutes
Other outcomes:
Locations:
Study officials:
affiliation: King Abdulaziz University
name: Samar M Al-Bazi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Bazi SM, Abbassy MA, Bakry AS, Merdad LA, Hassan AH. Effects of chlorhexidine (gel) application on bacterial levels and orthodontic brackets during orthodontic treatment. J Oral Sci. 2016;58(1):35-42. doi: 10.2334/josnusd.58.35.
Clinical trial NCT00909311: Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Official title: Randomized, Open-label, 2-period Cross-over Study in Healthy Adults to Evaluate the Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Keywords: Food effect
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Detailed description: This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.

Eligibility criteria: Inclusion Criteria:

* overall healthy subjects;
* non-childbearing potential females included

Exclusion Criteria:

* history of significant sensitivity to any drug;
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
* history of gastrointestinal issues or procedures;
* history of seizures, diabetes or cancer (except basal cell carcinoma);
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
* abnormal screening laboratory results that are considered clinically significant by the investigator;
* current enrollment in another clinical study;
* previous enrollment in this study;
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
* pregnant or breastfeeding female;
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Primary outcomes:
measure: Pharmacokinetics (blood draws, pre- and post-dose)
timeFrame: 17 days
measure: Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 19421
state: Illinois
Study officials:
affiliation: Abbott
name: Isabelle A Gaultier, M.S., IBMH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05851911: Passive Transmission of COVID-19 Antibody From Mother to Infant
Official title: Children's Hospital of Chongqing Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Passive Transmission of Maternal and Infant Antibodies
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples of infants not infected with COVID-19 and not vaccinated with COVID-19 vaccine

Brief summary: At present, there is no relevant research focusing on children's acquisition of novel coronavirus antibodies through maternal passive transmission. Therefore, this study assessed the changes of maternal passive transmission of COVID-19 antibodies by monitoring the specific antibodies of COVID-19 in young children; This will lay a foundation for further exploring the risk of COVID-19 infection in children and formulating immune prevention strategies.


Eligibility criteria: Inclusion Criteria:

1. Children aged 0-2;
2. No history of blood transfusion, chemotherapy, or related immunosuppressive therapy; No immune system related diseases;

Exclusion Criteria:

Not willing to participate

Primary outcomes:
measure: SARS-CoV-2 IgG
timeFrame: duration of time over which each participant could be 6-month to 12-month
measure: SARS-CoV-2 neutralizing antibody
timeFrame: duration of time over which each participant could be 6-month to 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Yuting Yang
state: Chongqing
Study officials:
References:
Clinical trial NCT06045611: The Effect of Oral Intake of Animal and Plant Proteins on the Metabolism in Healthy Women
Official title: The Effect of Oral Ingestion of Animal and Plant-based Proteins on the Somatotropic Axis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Protein
Plant-based protein
Metabolism
Somatotrophic Axis
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this interventional study is to learn about the effects of different proteins (from animals or plants) on the metabolism in healthy, normal weight women between 18-45 year who are not on hormonal birth-control.

The main questions the study aims to answer are:

1. How do different proteins affect biological markers of the metabolism and which protein has the strongest effect?
2. How are the different proteins digested and taken up from our body?

Participants will drink four different shakes on four different study days in a random order. Three of them contain each a different protein and one does not contain protein. Right before drinking the shake and on 11 timepoints after drinking the shake blood samples will be drawn.


Eligibility criteria: Inclusion Criteria:

* Females
* Age: 18-45 years
* Body mass index: 18.5 \< 25 kg/m2
* Signed informed consent

Exclusion Criteria:

* Use of hormonal contraceptives
* Pregnancy or breastfeeding
* Diabetes mellitus or any other metabolic disease that might affect the results of this study
* Gastric surgery that affects digestion and uptake of protein
* Any clinically significant present or past disease/condition and medication which in the investigator's opinion could interfere with the results of the trial

Primary outcomes:
measure: Release of Growth Hormone
timeFrame: 0-3 hours after consumption of test drink (on all 4 study days)
Secondary outcomes:
measure: Release of Hormones Related to the Somatotrophic Axis
timeFrame: 0-3 hours after consumption of test drink (on all 4 study days)
measure: Kinetics of Amino Acid Uptake
timeFrame: 0-3 hours after consumption of test drink (on all 4 study days)
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References:
Clinical trial NCT01580111: Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital
Official title: Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compare Blood Age for Transfusion
Keywords: Blood
Storage
Age
Transfusion
Lactic acidosis
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age

Detailed description: Objective of the study is to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anemia.

Methods:

Children aged 6 - 59 months admitted to ACU with Severe Malarial Anemia (Hb \<5g/dl) and Lactic Acidosis (blood lactate \>5 mmol /l), will be randomly assigned to receive either blood of shorter storage age (\<10 days) or longer storage age (21 -35 days) by gravity infusion as is the routine practice. 37 patients will be enrolled in each study arm. Physiological measurements namely blood lactate, oxygen saturation, Hemoglobin, Blood pressure, respiratory rate and pulse rate will be taken at baseline, during and after transfusion. The two groups will be compared. The primary outcome variable will be the proportion of children whose lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary outcome.

Eligibility criteria: Inclusion Criteria:Children aged 6 - 59 months admitted at Acute care Unit - Mulago hospital with;

1. A positive B/S for malaria
2. Severe anemia ( Hb ≤ 5 g/dl) and
3. Lactic Acidosis (Blood lactate ≥ 5 mmol/l)
4. Written informed consent from the caretaker.

Exclusion Criteria:

1. Children undergoing transfusion with blood products other than packed cells.
2. Children with known or concurrent cardiac disease.

Primary outcomes:
measure: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
timeFrame: 4hrs
Secondary outcomes:
measure: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
timeFrame: 24 HRS
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: Makerere University
name: AGGREY DHABANGI, MBChB, M.Med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhabangi A, Mworozi E, Lubega IR, Cserti-Gazdewich CM, Maganda A, Dzik WH. The effect of blood storage age on treatment of lactic acidosis by transfusion in children with severe malarial anaemia: a pilot, randomized, controlled trial. Malar J. 2013 Feb 6;12:55. doi: 10.1186/1475-2875-12-55.
Clinical trial NCT03725111: Haemodynamics Variations of Transcutaneous Oxygen in Patient With Areterio-venous Leg Ulcers Under Venous Compression
Official title: Haemodynamics Variations of Transcutaneous Oxygen in Patient With Arterio-venous Leg Ulcers Under Venous Compression (COMPULCE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcer
Compression; Vein
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap.

The management of leg ulcers is not clear and can be venous compression or surgery.

The aim of the study is to evaluate the variation of the transcutaneous oxygen with compression.

The second aim is to see how tolerate is the compression and the quality of life.


Eligibility criteria: Inclusion Criteria:

* age eighteen or more
* leg arteio-venous ulcers

Exclusion Criteria:

* age Under eighteen,
* Index pressure in the ankle Under 0.5

Primary outcomes:
measure: haemodynamic variation of the transcutaneous oxygen
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: ELHOMSY
state: Basse Normandie
Study officials:
References:
Clinical trial NCT04258111: IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
Official title: An Open-label, Multicenter, Phase 2 Study of IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR) /microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed colorectal adenocarcinoma
2. Imaging confirmed locally-advanced or metastatic colorectal cancer
3. Measurable disease by CT or MRI
4. MSI-H confirmed by central lab
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

1. Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
2. Subjects with active,known or suspected autoimmune disease
3. Subjects with a history of primary immune deficiency
4. Subjects with severe infectious diseases

Primary outcomes:
measure: ORR
timeFrame: Up to 3 years
Secondary outcomes:
measure: ORR in all MSI-H CRC patients based on investigator assessment.
timeFrame: Up to 3 years
measure: Progression-Free Survival (PFS) both by investigator and IRC
timeFrame: Up to 3 years
measure: Disease Control Rate (DCR) both by investigator and IRC
timeFrame: Up to 3 years
measure: Duration of Response (DoR) both by investigator and IRC
timeFrame: Up to 3 years
measure: Time To Response (TTR) both by investigator and IRC
timeFrame: Up to 3 years
measure: Overall Survival
timeFrame: Up to 3 years
measure: Incidence of adverse events (AE)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing cancer hospital
Study officials:
References: