louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01636492: A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
Official title: Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.


Eligibility criteria: Inclusion Criteria:

* Male healthy volunteer, 18 to 60 years of age inclusive
* Body mass index (BMI) 19-35 kg/m2 inclusive
* Supine blood pressure within the normal range of the center and heart rate \>/= 40 provided QTcB is \<450 ms
* Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion

Exclusion Criteria:

* History or evidence of any clinically significant disease or disorder
* Clinically significant ECG abnormalities
* Positive for hepatitis B, hepatitis C or HIV infection
* Previous treatment with iron for iron deficiency anemia
* Regular smoker (\>10 cigarettes, \>3 pipefuls or \>3 cigars per day)
* History of alcohol and/or drug abuse or addiction within the last 2 years before study start
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Participation in a clinical study with an investigational drug within the last three months prior to screening
* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigators or their designee

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 17 days
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve
timeFrame: Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose
measure: Pharmacokinetics: Urine concentrations drug/metabolites
timeFrame: Pre-dose and up to 72 hours post-dose
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05750992: Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section
Official title: Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section
Ultrasound Guided Transversus Abdominis Plane Block
Surgical Transversus Abdominis Plane Block
Bupivacaine
Acute Pain
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.

Detailed description: Caesarean delivery rates have been increasing worldwide nowadays. At rate of \[52%\], Egypt stands out among countries with the world's highest cesarean delivery percentages . Within the Arab region, rate of cesarean section far higher in Egypt than other Arab countries.

A much simpler and theoretically superior means of establishing a TAP block. When using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. Moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. Our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section.

Eligibility criteria: Inclusion Criteria:

* Full term pregnant women
* Older than 21 years of age
* Had elective cesarean section with Pfannenstiel incision.

Exclusion Criteria:

* Patients with cesarean section using different surgical incision
* History of addiction \[including opioids and benzodiazepines\]
* Allergy to the anesthetic analgesia
* Psychological disorders
* Coagulopathies
* Infection at the block injection site.

Primary outcomes:
measure: Time to perform block.
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: Heart rate
timeFrame: 24 hours postoperatively
measure: Mean arterial blood pressure
timeFrame: 24 hours postoperatively
measure: Pain score
timeFrame: 24 hours postoperatively
measure: Time to first analgesic request
timeFrame: 24 hours postoperatively
measure: Amount of post operative analgesic consumption
timeFrame: 24 hours postoperatively
measure: Time spent in operating room
timeFrame: 24 hours postoperatively
measure: Incidence of Adverse reactions
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kohaf
Study officials:
References:
Clinical trial NCT00834392: Exercise in Men With Prostate Cancer
Official title: A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Medical Service Foundation
First posted: 2009-02-03
Enrollment: 30
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.


Eligibility criteria: Inclusion Criteria:

* men aged 50 years or older
* diagnosed with adenocarcinoma prostate cancer
* will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment
* Patients will also consent to participating in the study.

Exclusion Criteria:

* severe cardiac disease (New York Heart Association class III or greater)
* angina
* severe osteoporosis
* uncontrolled hypertension (blood pressure \> 160/95mm Hg)
* orthostatic blood pressure drop \> 20mm Hg
* moderate to severe aortic stenosis
* acute illness or fever
* uncontrolled atrial or ventricular dysrhythmias
* uncontrolled sinus tachycardia (\> 120 beats per minute)
* uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (\> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).

Primary outcomes:
measure: bone health
timeFrame: baseline, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: C. Ellen Lee, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: CancerCare Manitoba
name: Y.K. James Lau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee CE, Leslie WD, Lau YK. A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Mar 21;12:103. doi: 10.1186/1471-2407-12-103.
Clinical trial NCT06010992: Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus
Official title: A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Menoufia University
First posted: 2023-08-25
Enrollment: 70
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: Diabetes mellitus (DM) is a complex metabolic disorder characterized by hyperglycemia and abnormalities in carbohydrate, fat, and protein metabolism. Despite the advancement in anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. This highlights the need for more effective strategies to control type 2 diabetes mellitus.

Nitazoxanide (NTZ), a broad-spectrum anti-infective drug with activity against various protozoa, helminthes, bacteria, and viruses, was identified as peroxisome proliferative activated receptor gamma (PPARγ) agonist using one dimensional drug profile matching. Additionally, it improved insulin sensitivity in insulin-resistant type 2 diabetic rats. Therefore, this study is designed to evaluate the efficacy of nitazoxanide as adjunctive therapy in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Glycated hemoglobin (HbA1c) between 7% and 9%.
* Body mass index ≥ 25 kg/m2

Exclusion Criteria:

* Pregnant or nursing women.
* Type 1 diabetes mellitus.
* Liver disease (alanine aminotransferase \> 3 upper normal limit).
* Kidney disease (estimated glomerular filtration rate \< 60 ml/min/1.73 m2).
* Inflammatory bowel diseases.
* History of allergy and/or adverse reactions to the drugs used in the study.

Primary outcomes:
measure: Glycemic control
timeFrame: 12 weeks
Secondary outcomes:
measure: Insulin resistance
timeFrame: 12 weeks
measure: Lipid profile
timeFrame: 12 weeks
measure: Serum levels of A-kinase anchoring protein 1
timeFrame: 12 weeks
measure: Serum levels of asprosin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of medicine, Tanta University
state: El-Gharbia
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine, Menoufia University
state: Menoufia
Study officials:
affiliation: Assistant Lecturer, Faculty of Pharmacy, Tanta University
name: Eman Ghonaim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04194892: A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
Official title: An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial Formulations of AM0010 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ARMO BioSciences
First posted: 2019-12-11
Enrollment: 12
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: The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.


Eligibility criteria: Inclusion Criteria:

* Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening
* Must be Human Immunodeficiency Virus (HIV) negative by HIV 1/0/2 testing.
* Must be Hepatitis B (HBV) surface antigen negative
* Must be Hepatitis C (HCV) antibody negative
* Females must have a negative serum pregnancy test

Exclusion Criteria:

* Pregnant or lactating subjects
* Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
* Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing
* Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
* Have been vaccinated within 90 days of study dosing

Primary outcomes:
measure: Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
timeFrame: Predose through approximately 14 days postdose
measure: PK: Time of Maximum Concentration (Tmax)
timeFrame: Predose through approximately 14 days postdose
measure: PK: Area Under the Serum Concentration Versus Time Curve (AUC)
timeFrame: Predose through approximately 14 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase 1 Clinic
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03807492: Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
Official title: Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 241
Sex: MALE
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: Any male \>18 years with prostate cancer is eligible. Furthermore, unaffected men at higher risk for prostate cancer (family history of prostate cancer or African American males) are also eligible for the study. Men will be approached by their providers or study staff during their clinical appointments for participation. Emails or mailings may also be sent to introduce the study to patients and to contact us for participation. Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR.

Brief summary: The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Men with a personal history of prostate cancer
* Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males)
* Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7
* Men with a known familial mutation
* Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR -

Exclusion Criteria:

* Age \< 18 years
* Mental or cognitive impairment that interferes with ability to provide informed consent

Primary outcomes:
measure: Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00314392: Gender, Pain, and Placebo Analgesia
Official title: Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental Pain
Keywords: Experimental pain
Placebo analgesia
Heart rate variability
Skin conductance
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Tromso
First posted: 2006-04-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. Physiological response to pain is recorded.

Detailed description: The social context in which pain is reported has been found to modulate pain. Specifically, male participants reporting pain to female observers report significantly lower pain levels compared to male participants reporting to male observers. Female participants seem less affected by social context. This is a methodological problem in the study of pain and has consequences in the development of new drugs, and for pain research in general.

The present study has two aims: To investigate whether social context affects also the placebo response to pain, i.e. the reduced pain often observed after administration of a an inert substance the participants believes to be a painkiller. It is hypothesized that placebo analgesia will be larger in males reporting pain to females. Secondly, heart rate variability and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded, to investigate if social context affects not only pain report, but also pain response.

Eligibility criteria: Inclusion Criteria:

* 18-40 years, healthy

Exclusion Criteria:

* pregnant, earlier serious disease or injury,

Primary outcomes:
measure: Pain report, heart rate variability, skin conductance
Secondary outcomes:
measure: Subjective arousal
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University of Tromso
name: Magne Arve Flaten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03657992: Time Trend Analysis of PE Diagnosis With SPECT V/Q: a Single Institution Observational Study
Official title: Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016

Brief summary: Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016

Exclusion Criteria:

* Patient under legal or judicial protection
* Patient opposed to the use of his medical data for research.

Primary outcomes:
measure: Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE
timeFrame: April 2011 to December 2016
Secondary outcomes:
measure: Risk of thromboembolic events (i.e. objectively confirmed pulmonary embolism or proximal deep vein thrombosis) during the 3-month follow-up period in patients left untreated based on a negative SPECT V/Q.
timeFrame: up to 3 Months following the date of the SPECT V/Q scan
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: