louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00865670: To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600 mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600 mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol dependence
* Female subjects who are pregnant or lactating

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
timeFrame: 32 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Alan S. Marion, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05552170: Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal
Official title: Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Fast Recovery Surgery
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All potential patients preparing for LIR were asked to undergo multiple evaluations at our outpatient department by gastrointestinal surgeons and anesthetists together. They were admitted to our ambulatory surgery center and included in the CHJ-ERAS program for ALIR if none of the exclusion criteria was met.

Brief summary: Based on enhanced recovery after surgery (ERAS), ambulatory loop ileostomy reversal (ALIR) has been reported in developed countries. However, there is still no research proposing how to carry out ALIR in developing countries. This study was performed to determine the feasibility of ALIR in China based on the community hospital joined enhanced recovery after surgery (CHJ-ERAS) program.

Detailed description: CHJ-ERAS program for ALIR was launched. Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation. Strict follow-ups were conducted after ALIR. The primary outcome was the results of short-term follow-ups.

Eligibility criteria: Inclusion Criteria:

1. Patients with ileostoma and preparing for LIR
2. Patients age between 18-65;
3. ASA grade II;
4. Patients willing to underwent day-case LIR

Exclusion Criteria:

* 1) Patients who underwent single-lumen ileostomy, transverse colostomy or Hartmann; 2) Complex previous laparotomies or required exploratory laparotomy; 3) Age over 65; 4) ASA grade over III (assessed by anesthetists); 5) Presence of moderate or severe preoperative anemia (hemoglobin \<90g/L); 6) Therapeutic anticoagulation or anti-platelet medications used within 1 week before surgery; 7) Patient refusal; 8) Severe co-morbidities or other conditions evaluated by surgeons or anesthetists not inappropriate to be included in the program.

Primary outcomes:
measure: Results of short-term follow-up
timeFrame: Within 1 month after surgery
measure: Readmissions
timeFrame: Within 1 month after surgery
measure: Reoperation
timeFrame: Within 1 month after surgery
Secondary outcomes:
measure: Hospital stays
timeFrame: 1 day
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04617470: Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study
Official title: Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study by MITO Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2020-11-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer

Brief summary: This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.

Detailed description: This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting. Will be enrolled all patients who have been part of the Italian Compassionate Use Program (CUP) prior to participating in this study. Once the CUP will be closed the trial will continue with th prospective collection of data of patients treated with Niraparib according to the label for 2 years.

Eligibility criteria: Inclusion Criteria:

* patients that received niraparib as monotherapy for the maintenance treatment of platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after response (complete or partial) to platinum-based chemotherapy as part of the CUP, regardless of whether the patient is receiving niraparib at the time of enrolment;
* patients with high grade serous ovarian cancer treated with Niraparib according to the label will be included;
* patients able to understand the study procedures and that agree to participate in the study by providing written informed consent

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to two years
Secondary outcomes:
measure: TFST
timeFrame: up to two years
measure: TSST
timeFrame: up to two years
measure: OS
timeFrame: up to two years
measure: ORR
timeFrame: up to two years
measure: Incidence of treatment-emergent adverse events
timeFrame: up to two years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT02049970: Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade
Official title: Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade for Forearm Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sequelae of Fracture of Forearm and Upper Arm
Keywords: Supraclavicular block
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 44
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: the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.

Detailed description: Anaesthesia for surgeries to the upper extremity commonly is provided using brachial plexus anaesthesia.Various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexmedetomidine are frequently used for this purpose. this study was conducted to compare the effects of adding dexmedetomidine to local anaesthetics in the supraclavicular brachial plexus block by using nerve stimulators and ultrasonography guided. dexmedetomidine has also been found the prolong the duration of bupivacaine infraclavicular brachial plexus block.

Eligibility criteria: Inclusion Criteria:

* 18-65 age
* unwanted general anaesthesia
* ASA 1-2
* single forearm, arm surgery

Exclusion Criteria:

* major psychiatric problems
* major neurologic deficits
* coagulopathy
* drug allergies
* chronic analgesic used

Primary outcomes:
measure: the duration of sensorial block
timeFrame: postoperative 1 day
Secondary outcomes:
measure: the first time analgesic required
timeFrame: postoperative 1 day
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
Study officials:
affiliation: Ass.Prof.
name: Recep Aksu
role: STUDY_DIRECTOR
References:
Clinical trial NCT04257175: CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression
Official title: Giving CAR-T CD19 Transgenic T Cells for Acute Myeloid Leukemia Patients (AML) With t 8:21 and CD19 Expression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Chimeric antigen receptors; Mixed phenotype acute leukemia; T cells.
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 10
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: Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel.

However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia.

The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.


Eligibility criteria: Inclusion Criteria:

* Patients with recurrent acute myeloid leukemia (AML) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or FLT3 inhibitors in patients with FLT3 .

Exclusion Criteria:

* Heart disease including severe heart failure (NYHA III-IV), recent MI or CABG surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, LVEF less than 45%
* Active involvement of CNS
* Active infection
* Pregnancy or lactation
* Graft versus host disease III-IV grade - Stroke or seizure in the last six months before treatment
* A positive result for the HIV infection (serum)
* Active hepatitis infection
* Life-threatening allergies to cyclophosphamide or fludarabine
* No informed consent signed by candidate
* Candidate enrolled in other study

Primary outcomes:
measure: The change in the peripheral blood counts and differential
timeFrame: Within two years from the introduction of the CAR-T CD19
measure: The change in the antigen expression on the leukemic blasts
timeFrame: Within two years from the introduction of the CAR-T CD19
measure: The change in the measurable residual disease
timeFrame: Within two years from the introduction of the CAR-T CD19
measure: The change in the chromosomal translocations and aberrations
timeFrame: Within two years from the introduction of the CAR-T CD19
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
References:
Clinical trial NCT06468475: Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia
Official title: Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Asphyxia
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children's Hospital Multan is a tertiary care teaching hospital in South Punjab, the poorest and most backward area of Punjab, Pakistan, where a significant number of newborns suffer from birth asphyxia. Therefore, this study was planned with the objective of investigating the effectiveness of magnesium sulphate in severe birth asphyxia, hypothesizing that in cases of birth asphyxia, neonates who are treated with magnesium sulphate have a higher sucking reflex than those who are not treated with magnesium sulphate.


Eligibility criteria: Inclusion Criteria:

* Full-term babies (≥37 weeks of gestation)
* Both genders
* Severe birth asphyxia
* Admitted within six hours of life.

Exclusion Criteria:

* Premature babies
* Congenital malformations
* Babies born to mothers who received general anesthesia
* Babies whose mothers received magnesium sulfate, pethidine, and other drugs in the past 7 days.

Primary outcomes:
measure: Efficacy
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: The Children's Hospital and the Institute of Child Health
state: Punjab
Study officials:
References:
Clinical trial NCT02077075: MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel
Official title: The Effectiveness of the MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight
Keywords: weight loss
healthy weight
overweight
body mass index greater that 25 kg/m2
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 117
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 research is collecting data to determine the benefits of a web-based wellness program designed to improve the health and well-being of individuals in the workplace. Participants will be invited to participate in a web-based Healthy Weight Program. The program is designed to optimize health and wellbeing by promoting physical activity and healthy eating.


Eligibility criteria: Inclusion Criteria:

* A military member of the Canadian Forces Base in Halifax

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Body weight
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Waist circumference
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Canadian Forces Base Halifax
state: Nova Scotia
Study officials:
affiliation: McGill University
name: Steven Grover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832975: AVAI: Atrial Ventricular Arrythmia Incidence
Official title: Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a St. Jude Medical ICD

Brief summary: The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

Detailed description: The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.

Eligibility criteria: Inclusion Criteria:

* Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
* Patient has signed the study specific Informed consent document.
* Patient is older than 18 years of age

Exclusion Criteria:

* Patient has a permanent Atrial Fibrillation
* Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
* Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
* Patient requires cardiac resynchronization
* Patient has Brugada Syndrome
* Patient has long QT Syndrome
* Patient has a device replacement;
* Patient is pregnant or nursing
* Patient is unable to attend the follow-up visits

Primary outcomes:
measure: Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)
timeFrame: 24 months
Secondary outcomes:
measure: Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure
timeFrame: 24 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
Study officials:
affiliation: Hospital Universitario Puerta de Hierro
name: Ignacio Fernández Lozano, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico Universitario Virgen de la Victoria
name: Javier Alzueta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04526275: Development of Validated Bruise Scale in HNV
Official title: Development of a Bruise Scale in Healthy Normal Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bruise, Contusion
Lead sponsor: Cearna, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Normal Volunteers

Brief summary: Subjects will have a mechanically induced bruise photographed over a period of 11 days to record the healing process. Assessors will rate the bruises to develop a bruising scale.

Detailed description: Observational study. Healthy normal volunteers will come into the clinic and have a bruise induced. The bruised area will be photographed each day through Day 11. Images will be provided to the Validator Team to rate on a 0-5 scale of severity.

The actual numbers of volunteers will be adjusted to ensure there are at least 15 images for each Grade.

The clinical site will be provided photography equipment, and study staff will be trained on photography technique to standardize the image quality and resolution across the study.

The Validator Team will review the images and categorize them in to Grades 0-5.

Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin type 1-3
* BMI 25 kg/m2
* Self described bruisers
* Intact skin in the target area, free of markings, blemishes and hair

Exclusion Criteria:

* Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
* Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
* Inability to forego application of topical products in the target area
* Hair removal by laser, wax or chemicals within one week prior to Day 1
* Avoid tanning beds
* Active wound or infection in the target area
* History of keloids or hypertrophic scarring
* History of collagen or vascular disease
* History of organ transplant

Primary outcomes:
measure: Bruise Healing over time
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Artemis Clinical Research
state: California
Study officials:
References:
Clinical trial NCT06526975: Study of Different Exercise Doses Through Videogames in Older Adults
Official title: Study of Different Exercise Doses Through Digital Gamification in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adult
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to assess the feasibility of applying different gamified exercises doses in older adults. It will also learn from possible adverse effects of the intervention.

The main questions this clinical trial aims to answer are:

* Are there any differences between heart rate, perceived exertion and enjoyment between groups?
* Are there any adverse effects? What is the magnitude of these adverse effects?
* Are there any correlations between gamification time and the occurrence of adverse effects?

Detailed description: A randomised clinical trial will be conducted in which the use of exercise doses between 10 and 30 will be tested. Participants will be recruited from Nueva Esperanza nursing home, Fuensalida, Toledo. The study will be conducted according to the CONSORT statement for clinical, crossover and parallel trials.

The study will have a total of two experimental groups, with different intervention times, between 10 and 30 minutes, respectively, using a mobile application. The intervention will consist of performing exercise in pairs in a single bout during the mentioned times.

Eligibility criteria: Inclusion Criteria:

* subjects over 60 years of age
* score equal to or greater than 20 on the Mini Mental cognitive test
* Subjects that present the ability to stand without the use of technical aids or with the technical assistance of a device used for walking.

Exclusion Criteria:

* severe visual impairment
* medical contraindication for physical activity
* pathology or problem that could prevent the test from being carried out.

Primary outcomes:
measure: Heart Rate
timeFrame: Heart rate is measured thourought the intervention, once the intervention is finished (10 to 30 minutes) recording of heart rate will stop.
measure: Rate of perceived exertion
timeFrame: RPE will be measured at half time and once the intervention is finished for both groups.
measure: Exercise satisfaction
timeFrame: It will be measured on the same day intervention finishes, up to 5 hours post-intervention.
measure: Adverse effects
timeFrame: 24 and 48 hours post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Fuensalida
country: Spain
facility: Nueva Esperanza Nursing Home
state: Toledo
city: Toledo
country: Spain
facility: Universidad de Castilla La Mancha
Study officials:
References: