louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00346242: Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Official title: Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thalassemia
Keywords: thalassemia
zoledronic acid
skeletal events
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The evaluation of efficacy is performed by laboratory monitoring of bone density and resorption markers and clinical monitoring of bone density improvement. This is a prospective, randomized, parallel group, single blind study of one year treatment with zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3 months and to placebo every 3 months in patients with hemoglobin syndromes and risk of skeletal complications.


Eligibility criteria: Inclusion Criteria:

* Patients with thalassaemia or sickle cell anaemia and bone density, z-scores \< -1.5, in at least one of the examined sites
* Normal renal function. Urea and creatinine should not exceed \> 2-fold the upper limit of normal (\< 2 x ULN).

Exclusion Criteria:

-

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: Bone density by means of bone densitometry with dual energy x-ray absorptiometry (DEXA) at three body sites (lumbar region, femoral head, wrist) prior to treatment initiation the start and at the end of treatment
measure: N-telopeptide of type I collagen (NTx) levels, TRACP-5b, with ELISA, prior to the start of treatment initiation and every 3 or 6 months
measure: Serum Bone alkaline phosphatase, Osteocalcin, OPG and S-RANKL with ELISA, prior to the start of treatment initiation, and every 3 or 6 months
Secondary outcomes:
measure: Biochemistry (Ca, P, urea/creatinine, SGOT/SGPT, ALT, γGT), endocrine and cardiac test prior to the start of treatment initiation and at 6 and 12 month.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Voskaridou E, Christoulas D, Xirakia C, Varvagiannis K, Boutsikas G, Bilalis A, Kastritis E, Papatheodorou A, Terpos E. Serum Dickkopf-1 is increased and correlates with reduced bone mineral density in patients with thalassemia-induced osteoporosis. Reduction post-zoledronic acid administration. Haematologica. 2009 May;94(5):725-8. doi: 10.3324/haema-tol.2008.000893.
Clinical trial NCT02593942: Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy
Official title: Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Supratentorial Neoplasms
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for this purpose. The hemodynamic stability and at the same time early emergency are the main goals following neurosurgery. However there is no standard for discontinuation time for manually controlled systems today.

The investigators aimed to study the effect of remifentanil infusion alone for early emergence and hemodynamic stability during the closure period in patients undergoing supratentorial craniotomy.

Detailed description: Adult, American society of Anaesthesiologist score I-II, 80 patients who underwent elective supratentorial craniotomy for tumour resection were randomly assigned to group I or II. In group I; propofol was discontinued during the dural closure. After the propofol was discontinued, remifentanil dose was increased with the guidance of bispectral index spectrum and hemodynamic parameters. In group II; propofol discontinued before the end of the surgery. Time to awakening and extubation time, adverse events, total remifentanil and propofol consumptions and side effects were recorded. Heart rate and blood pressure were recorded during this period.

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologist physical status I-II
* Glasgow Coma Scale score of 15 points
* Elective supratentorial craniotomy for tumor resection
* Supine position

Exclusion Criteria:

* Obese patient
* Brain tumor greater than 30 mm in diameter
* Postoperative cranial drainage
* Hypertension
* Diabetes mellitus
* Reoperation
* Pregnant
* Breast feeding
* Allergy to the study medications
* History of cranial radiotherapy
* Frontal bone flap
* Intraoperative neuromonitoring

Primary outcomes:
measure: Time of extubation
timeFrame: 3 hours
Secondary outcomes:
measure: Heart Rate
timeFrame: 6 hours
measure: Mean arterial pressure were recorded
timeFrame: 6 hours
measure: Post-anesthesia awaking time
timeFrame: 3 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University Hospital
Study officials:
affiliation: Yeditepe University
name: Hatice Ture, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06659770: A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma
Official title: A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: CARsgen Therapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 200
Sex: ALL
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: This study was conducted in a medical institution that has been commercially evaluated and certified. Before carrying out the corresponding procedures for the study, the informed consent signed by the subjects themselves must be obtained, and for patients who do not have full civil capacity, the informed consent of their guardians must be obtained.

Brief summary: This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world.

Detailed description: Primary study endpoints:

Overall Survival Rate (OS Rate) at 24 months after infusion：Survival rate from the start of cell infusion to 24 months after infusion.

Secondary study endpoints:

Incidence and Severity of Treatment-Related Adverse Events (TEAEs) for zevor-cel Incidence and severity of adverse events (AEs) related to study treatment Incidence of serious adverse events (SAEs) related to study treatment

Other efficacy endpoints of zevor-cel:

Overall response rate (ORR)：Proportion of subjects with a partial response (PR) or above.

Complete response or stringent complete response rate (CR/sCR) ：The proportion of subjects with the best response of CR/sCR.

Duration of Response (DOR)：The time from first response to disease progression or death caused by any reasons in subjects with the best response of PR and above.

Progression Free Survival (PFS) Overall survival (OS)： The time from the start of cell infusion to death due to any cause.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
3. Voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians.

Exclusion Criteria:

1. There were no specific exclusion criteria for this study。

Primary outcomes:
measure: To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00616070: Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.


Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral ocular surgery.

Exclusion Criteria:

* Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.

Primary outcomes:
measure: The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups
timeFrame: Day 14
Secondary outcomes:
measure: The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups.
timeFrame: Day 7
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat
state: North Carolina
Study officials:
affiliation: Sirion Therapeutics
name: Roger Vogel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02582970: A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
Official title: An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-21
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: TREATMENT

Brief summary: This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.


Eligibility criteria: Inclusion Criteria:

* Previously untreated metastatic colon or rectal cancer
* Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment

Exclusion Criteria:

* Prior chemotherapy for metastatic colon or rectal cancer
* Planned radiotherapy for underlying disease
* Central nervous system metastases
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
* Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 3 years
Secondary outcomes:
measure: Percentage of Participants Who Died
timeFrame: Baseline up to approximately 3 years
measure: Duration of Survival
timeFrame: Baseline up to approximately 3 years
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Baseline up to approximately 3 years
measure: Progression-Free Survival Time
timeFrame: Baseline up to approximately 3 years
measure: Number of Participants With Best Overall Response
timeFrame: Baseline up to approximately 3 years
measure: Mean Direct Medical Cost for Cancer Related Medical Care Utilization
timeFrame: Baseline up to approximately 3 years
Other outcomes:
Locations:
city: Chai Yi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT06596070: Clinical Study of Intestinal Barrier Dysfunction After Gastrointestinal Surgery
Official title: Clinical Study of Intestinal Barrier Dysfunction in Patients After Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intestinal Barrier Dysfunction
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People undergoing gastrointestinal surgery

Brief summary: The goal of this observational study is to explore the clinical influences associated with the development of intestinal barrier dysfunction in patients undergoing gastrointestinal surgery. The main question it aims to answer is:What clinical factors increase the probability of developing intestinal barrier dysfunction in patients after gastrointestinal surgery?


Eligibility criteria: Inclusion Criteria:

* men or women aged 18-80 years
* expected feasible abdominal surgical treatment (partial gastrectomy, colorectal resection)
* no preoperative intestinal barrier dysfunction
* patients voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria:

* Patients or their families refused to participate in this study
* chronic inflammatory diseases (e.g. inflammatory bowel disease, chronic hepatitis, chronic pancreatitis, chronic peptic ulcer, etc.)
* history of antibiotic administration in the last 2 weeks
* severe cognitive impairment and other inability to cooperate preoperative neoadjuvant radiotherapy
* combined with severe hepatic, renal, and cardiac insufficiency patients.

Primary outcomes:
measure: operating time
timeFrame: During surgery
Secondary outcomes:
measure: nutritional status
timeFrame: Preoperative
measure: bowel habit
timeFrame: Preoperative
measure: Surgical Procedures
timeFrame: During surgery
measure: hemorrhage
timeFrame: During surgery
measure: Albumin
timeFrame: Preoperative and postoperative 24 hours
measure: Infection indicators
timeFrame: Preoperative and postoperative 24 hours
measure: age
timeFrame: Preoperative
measure: gender
timeFrame: Preoperative
measure: Body Mass Index
timeFrame: Preoperative
measure: diabetes
timeFrame: Preoperative
measure: enteral nutrition
timeFrame: The average observation time is 2 weeks after surgery.
measure: Exhaust and defecation time
timeFrame: The average observation time is one week after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03945942: Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices
Official title: Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant; Complications
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 33
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.

Detailed description: Hyperbilirubinaemia may interfere with oximetry values as measured by Near Infrared Spectroscopy devices. The number of wave lengths used by different devices can influence the oximetry values in adult patients. This has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.The study will compare cerebral and somatic oximetry values measured by two different Near infrared spectroscopy devices (FORESIGHT and INVOS) and analyse the influence of bilirubin levels on these differences.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution
* Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure

Exclusion Criteria:

* refusal of the patient or his parents to consent
* known brain or Neurological pathology

Primary outcomes:
measure: influence of chromophores such as bilirubin on oximetry values provided by two different devices
timeFrame: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: natalia.magasich@uclouvain.be
name: Natalia MAGASICH-AIROLA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04300842: Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices
Official title: Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer-Related Condition
Keywords: Cancer-related fatigue
smart bracelet device
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with some cancer treatment side effects. Healthy people compare with cancer patients who no cancer disease now.

Brief summary: This project expects to enroll 60 cancer patients, 60 healthy people and their subjective-objective measurements on fatigue, stress, and total steps will be validated so that the information can be used in further care and improvement of life of quality of the patients.


Eligibility criteria: Inclusion Criteria:

* Age ≧ 20 years old;
* One group had a cancer diagnosis, one group no cancer diagnosis;
* Can continuous wearing bracelet for 5 days or more

Exclusion Criteria:

* Unclear and unable to answer the questionnaire

Primary outcomes:
measure: fatigue
timeFrame: over 5 days
measure: Heart Rate Variability (HRV) monitor
timeFrame: over 5 days
Secondary outcomes:
measure: Distress Thermometer(DT)
timeFrame: over 5 days
measure: Leeds Sleep Evaluation Questionnaire(LSEQ）
timeFrame: over 5 days
measure: International Physical Activity Questionnaire(IPAQ）
timeFrame: over 5 days
measure: Perceived Stress Scale (PSS）
timeFrame: over 5 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References:
Clinical trial NCT01205542: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
Official title: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Neck Pain
Shoulder Pain
Scapular Dyskinesis
Muscle Activation
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: University of Southern Denmark
First posted: 2010-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder pain, but it is uncertain whether training should focus directly on the upper trapezius - which is most often tender - or on the lower compartments and serratus anterior.

We hypothesize that strengthening exercise for the lower and middle trapezius as well as the serratus anterior will decrease intensity of neck/shoulder pain among office workers


Eligibility criteria: Inclusion Criteria:

* employees
* more than 30 days with pain previous year
* pain intensity of at least 3 on a scale of 0-10

Exclusion Criteria:

* trauma
* life threatening disease
* pregnanacy

Primary outcomes:
measure: Neck/shoulder pain
timeFrame: December 2010
Secondary outcomes:
measure: Muscle function
timeFrame: December 2010
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde University Center
Study officials:
References:
citation: Andersen CH, Andersen LL, Mortensen OS, Zebis MK, Sjogaard G. Protocol for shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial. BMC Musculoskelet Disord. 2011 Jan 14;12:14. doi: 10.1186/1471-2474-12-14.