louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01756924: Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prosthetic Joint Infections of Hip
Prosthetic Joint Infections of Knee
Infected Spacers
Keywords: prosthetic joint infection
hip arthroplasty
MRSA
knee arthroplasty
Lead sponsor: Arrevus Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-28
Enrollment: 14
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: To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections


Eligibility criteria: Inclusion Criteria:

* Prosthetic knee or hip joint infection
* Infected joint spacer
* Able to swallow tablets
* Able to voluntarily sign the informed consent form
* Females of childbearing potential must use an acceptable method of birth control
* The joint infection must be attributed to bacterial pathogens sensitive to fusidic acid and rifampin

Exclusion Criteria:

* History of hypersensitivity or intolerability to sodium fusidate (Fucidin®), or to rifampin
* Females who are pregnant or lactating
* Requirement for significant immunosuppression
* Bacteremia
* Known cirrhosis or decompensated liver disease
* Current treatment for HIV or Hepatitis C
* Seizure disorder, requiring anti-convulsants

Primary outcomes:
measure: Bacterial eradication of joint infection
timeFrame: 3 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Syracuse
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
References:
citation: Pushkin R, Iglesias-Ussel MD, Keedy K, MacLauchlin C, Mould DR, Berkowitz R, Kreuzer S, Darouiche R, Oldach D, Fernandes P. A Randomized Study Evaluating Oral Fusidic Acid (CEM-102) in Combination With Oral Rifampin Compared With Standard-of-Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction. Clin Infect Dis. 2016 Dec 15;63(12):1599-1604. doi: 10.1093/cid/ciw665. Epub 2016 Sep 28.
Clinical trial NCT06442124: The Effect of BMI on Gluteus Maximum Activity in Adulthood With Sacroiliac Dysfunction
Official title: The Effect of BMI on Gluteus Maximum Activity in Adulthood With Sacroiliac Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sacroiliac Joint Dysfunction
Obesity
EMG
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects:

A total of 60 male \& female subjects, diagnosed with sacroiliac dysfunction participated in this study. Their BMI will from 20- 30kg/m2.

Brief summary: PURPOSE:

This study will be conducted to investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction BACKGROUND: Sacroiliac joint (SIJ) pain is pain arising from SIJ structures and SIJ dysfunction (SIJD) generally refers to aberrant position or movement of SIJ structures . An estimated 15-30% of all low back pain cases are due to SIJ pain The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction

HYPOTHESES:

. •There will be no effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction

RESEARCH QUESTION:

* Do BMI has an effect on gluteus maximum activity in adulthood with sacroiliac dysfunction?


Eligibility criteria: Inclusion Criteria:

- adulthood with sacroiliac dysfunction

* Their ages will range from 20-40 years old.
* Their BMI will be less than 20- 30kg/m2.
* All of them suffer from mild to moderate degree of sacroiliac pain.
* The subjects complain from sacroiliac pain for 1 month ago

Exclusion Criteria:

* Exclusion criteria were a history of any of the following condition:

  * inflammatory diseases or any rheumatic disorders,
  * a history of vertebral fractures
  * surgical spinal fixation.
  * •any neurological disorders like MS

Primary outcomes:
measure: gluteus maximum muscle activity measured by Electromyography (EMG)
timeFrame: up to 8 weeks
measure: weight and height will be combined to report BMI in kg/m^2)
timeFrame: up to 8 weeks
measure: visual analogue scale for pain
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram Canadian university
Study officials:
References:
Clinical trial NCT02505724: Peer-coaching to Teach Faculty Surgeons an Advanced Laparoscopic Skill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coaching
Technical Skill
Laparoscopy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This single-blinded randomized controlled trial assesses the efficacy of peer-coaching to teach novice surgical faculty an advanced laparoscopic skill.


Eligibility criteria: Inclusion Criteria:

* surgical faculty in the division of general surgery or obstetrics and gynaecology.
* novices in laparoscopic suturing (performed \<20 intra-corporeal stiches and knots)

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Technical Skill
timeFrame: Two weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05465824: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED
Official title: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 7876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a suspected Covid 19

Brief summary: Descriptive study of patients with suspected COVID-19 upon ED arrival of European hospitals between March 09 and April 08 2020.

Justification:

Detailed description: Descriptive study of patients with suspected COVID-19 upon ED arrival of European hospitals between March 09 and April 08 2020.

Justification:

Over the past 3 months, the world has faced a novel infection disease outbreak, due to a novel coronavirus, the severe acute respiratory syndrome coronavirus (SARS-CoV2), with a massive impact on healthcare resource.

In Europe, numbers of confirmed cases continue to rise. Europe is currently one of the regions with the highest number of Covid-19 cases and deaths due to this emergent diseases.

Most COVID-19 infected patients present with mild to moderate acute respiratory symptoms, including cough, fever, dyspnea and pneumonia. About 20% will present with severe or critical manifestations of the disease, including pneumonia, respiratory failure and acute respiratory distress syndrome (ARDS).

Anticipating the needs for hospitalization in ward and/or intensive care is crucial.

Emergency departments are at the front line for triaging patients with suspected Covid-19 and referring them to the appropriate level of care.

In Europe, the number of ED patients with suspected Covid-19 is variable; rate of hospitalization from ED reaches 40% for this population.

Risk stratification and management decisions of patients presenting to the ED with suspected COVID-19 is a challenge for emergency physicians.

Eligibility criteria: Inclusion Criteria:

Adult patients (\>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria

* Fever \>= 38 °C
* respiratory symptoms (dyspnea, cough, expectorations)
* any other symptoms suggestive of COVID-19 including digestive signs (diarrhea, anosmia...)

Exclusion Criteria:

* No insurance
* patients less than 18 years

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Tours University Hospital
Study officials:
References:
Clinical trial NCT03805724: Entamoeba Gingivalis and Periodontal Disease
Official title: Is Entamoeba Gingivalis A Risk Factor In Periodontal Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Gingivitis \& Chronic periodontitis patients will be selected from the outpatients Clinic, Department of Oral Medicine, Periodontology and Diagnosis, Faculty of Dentistry, Fayoum University. Clinical examination for all patients will be performed including the following periodontal parameters: plaque index, gingival index, probing depth, and clinical attachment level. These measurements will be recorded by a single calibrated expert examiner at six sites for all teeth (mesiobuccal, mesiolingual, midbuccal, distobuccal, distolingual, and midlingual). PI is assessed by measuring the presence or absence of supragingival biofilm with a sweeping movement of the probe around the surfaces of all teeth

Brief summary: This current study aims to clarify the relationship between the occurrence of Entamoeba gingivalis infection and the specter of gingivitis \& chronic periodontitis among Egyptian patients in comparison to healthy volunteers as a control group.

Detailed description: Three groups will be included in the current study. 40 Plaque samples will be collected from gingivitis patients (group 1), 40 from chronic periodontitis patients (group 2) plus 40 samples from healthy volunteers (group 3). Diagnosis of parasitic stages will rely on direct microscopic detection using permanent stains, Trichrome stain and haematoxylin and eosin stain in addition to direct wet mount examination.

Eligibility criteria: Inclusion Criteria:

* Chronic Gingivitis patients with signs of clinical inflammation with no clinical attachment loss.
* Chronic Periodontitis patients having probing depth of ≥3 mm and clinical attachment level ≥ 1 mm.
* The control group: healthy subjects who attend the restorative dental clinic and had clinically healthy gingiva.

Exclusion Criteria:

* Patients with any systemic diseases

Primary outcomes:
measure: Presence of Entamoaba Gingivalis parasite in dental plaque assessed by direct microscopic examination
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Gihane G Madkour, Ass Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01034124: Mechanisms Underlying Drug-Diet Interactions
Official title: Mechanisms Underlying Drug-Diet Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Keywords: warfarin
midazolam
cranberry juice
pharmacokinetics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Healthy
* Not taking medications known to modulate CYP2C9 and CYP3A activity
* Able to understand the consent process

Exclusion Criteria:

* Allergy to cranberry products, warfarin, vitamin K, or midazolam
* Pregnant or breast-feeding women
* Baseline INR \>1.2
* History of significant medical conditions that could increase risk
* Concomitant medications known to modulate CYP2C9 and CYP3A activity

Primary outcomes:
measure: AUC
timeFrame: 0-96 hr
Secondary outcomes:
measure: Cmax
timeFrame: varies
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill General Clinical Research Center
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Mary F Paine, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngo N, Yan Z, Graf TN, Carrizosa DR, Kashuba AD, Dees EC, Oberlies NH, Paine MF. Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans. Drug Metab Dispos. 2009 Mar;37(3):514-22. doi: 10.1124/dmd.108.024968. Epub 2008 Dec 29.
Clinical trial NCT05428124: Poor In Vitro Fertilisation Outcomes in Genital Tuberculosis - Case Report
Official title: Poor In Vitro Fertilisation Outcomes in Genital Tuberculosis - Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Female Genital
Fertility Disorders
Keywords: In vitro fertilisation
Genital tuberculosis
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 7
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with confirmed genital tuberculosis previously diagnosed during laparoscopy to undergo in vitro fertilisation

Brief summary: This is a case series that highlights the challenges in instituting in vitro fertilisation (IVF) treatment amongs genital tuberculosis patients.

Detailed description: In this case series, the investigators recruited patients undergoing IVF treatment previously diagnosed with TB between 01/01/2014 and 30/06/2021. Patients were recruited at the beginning of their IVF treatments. Total sampling was employed for this study.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed genital tuberculosis enrolling in in vitro fertilisation treatment

Exclusion Criteria:

* patients not confirmed to having genital tuberculosis

Primary outcomes:
measure: Live birth rate
timeFrame: 9 months of gestation
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 9 months of gestation
Other outcomes:
Locations:
Study officials:
affiliation: Universitas Padjadjaran
name: Kevin D Tjandraprawirra, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma JB. Current Diagnosis and Management of Female Genital Tuberculosis. J Obstet Gynaecol India. 2015 Dec;65(6):362-71. doi: 10.1007/s13224-015-0780-z. Epub 2015 Oct 7.
citation: Djuwantono T, Permadi W, Septiani L, Faried A, Halim D, Parwati I. Female genital tuberculosis and infertility: serial cases report in Bandung, Indonesia and literature review. BMC Res Notes. 2017 Dec 4;10(1):683. doi: 10.1186/s13104-017-3057-z.
citation: Dai W, Ma L, Cao Y, Wu D, Yu T, Zhai J. In vitro fertilization outcome in women with endometrial tuberculosis and tubal tuberculosis. Gynecol Endocrinol. 2020 Sep;36(9):819-823. doi: 10.1080/09513590.2019.1702639. Epub 2019 Dec 17.
Clinical trial NCT00006434: Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin
Keywords: Dendritic cells
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-11-06
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: When patients relapse after primary chemotherapy for Non-Hodgkin's lymphoma, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it. This study is being conducted to determine the safety, side effects, and the ability to respond to an investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune stimulating drug called interleukin-2. The patient must have a lymphomatous node accessible for excision to prepare the vaccine. Dendritic cells are immune cells that are obtained from the blood, and are important in the body's immune response to foreign substances. This study will examine the response of the immune system after three vaccinations (composed of dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning three months after transplant. Vaccination may result in sensitizing the patient's dendritic cells to his lymphoma cells, potentially resulting in an immune response against the lymphoma. Twelve patients will be treated on study.


Eligibility criteria: Inclusion Criteria:

* Histologically documented, aggressive and/or intermediate grade NHL, B-cell and T-cell.
* In relapse after first-line conventional chemotherapy. Primary therapy should include a doxorubicin-based regimen.
* Patients must have disease sensitive to induction chemotherapy, radiation therapy, and/or radioimmunotherapy. Successful treatment of CNS or meningeal disease is allowed.
* Patients must have accessible tumor for biopsy or excision.
* Cumulative total doxorubicin: \<500 mg/m2
* Performance score 0-2
* No prior pelvic RT
* Patients with a prior malignancy are eligible if they were treated for cure and have no evidence of active disease.
* Patients may not be taking immunosuppressive agents.
* Informed Consent; IRB approval

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
References:
Clinical trial NCT06335134: A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
Official title: A Single-Center, Open-Label Study to Evaluate the Effect of XW003 Injection on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin or Digoxin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Ecnoglutide
XW003
Metformin
Warfarin
Rosuvastatin
Digoxin
Lead sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

Detailed description: This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-45 years old, inclusive;
2. BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
3. Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.

Exclusion Criteria:

1. Presence of clinically significant conditions (including but not limited to respiratory system, cardiovascular system, gastrointestinal system, endocrine system, immune system, integumentary system, nervous system, ENT or other related diseases);
2. History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
3. Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;
4. History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;
5. History of acute or chronic pancreatitis;
6. History of documented or suspected hypoglycemic episodes within 6 months prior to screening;

Primary outcomes:
measure: Pharmacokinetics of metformin: AUC0-inf
timeFrame: up to 101 days
measure: Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf
timeFrame: up to 114 days
measure: Pharmacokinetics of rosuvastatin: AUC0-inf
timeFrame: up to 102 days
measure: Pharmacokinetics of digoxin: AUC0-inf
timeFrame: up to 112days
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Second University Hospital
name: Qin Yu
role: PRINCIPAL_INVESTIGATOR
References: