louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03332693: Macroscopic and Molecular Changes in Knee Muscular - Tendon Unit in Response to Acute Resistant Load
Official title: Macroscopic and Molecular Changes in Knee Muscular - Tendon Unit in Response to Acute Resistant Load
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Exertion
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-11-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to determine whether individuals differ one from the other in their genetic, cellular, systemic, structural and functional response to acute exercise.


Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Unhealthy adults

Primary outcomes:
measure: Genetic polymorphism changes in knee muscles
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Eias Kassem, MD
role: STUDY_DIRECTOR
affiliation: Wingate Academic College for Physical Education and Sport Sciences
name: Sigal Ben Zaken, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04957693: Effect of Vegan Diet and Lifestyle Changes on Indolent Lymphoma During Controlled Waiting Period
Official title: Effect of Vegan Diet and Lifestyle Changes on the Course and Progression of Indolent Lymphoma During Controlled Waiting Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Indolent Lymphoma
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: KaMaH - The Center for Health-Promoting Therapies
First posted: 2021-07-12
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: The aim of the present trial is to evaluate the effect of lifestyle changes on the natural history of indolent lymphomas, during the period of watchful waiting. The intervention program is comprised of specifically designed vegan nutrition, physical activity, mostly aerobic, and stress reduction by relaxation and meditation. Outcome results will be followed and analyzed for 3 years, taking into consideration the following parameters - disease burden, specific disease-related symptoms, relevant blood tests, body weight, indicators of well-being. Changes in these parameters will be correlated with the level of compliance and adherence to the intervention program. The results of the trial group of patients will be further compared to the natural history of the disease in a comparable group of patients during their waiting period who were not subject to the above intervention.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patient sex - male and female
* Diagnosis with indolent lymphoma in low-grade lymphoma (follicular lymphoma (FL), marginal zone lymphoma MZL), as assessed by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
* Lack of need and non treatable patients at the time of diagnosis
* Existence of detailed medical information about physical activity and dietary habits
* Patients who have signed an informed consent form to participate in the study.

Exclusion Criteria:

* Need for therapeutic intervention
* Administration of chemotherapy and / or monoclonal antibodies or immunomodulatory preparation
* Chronic inflammatory or infectious disease
* Another malignant disease
* Pregnant women, special populations - children and incapacitated of judgment

Primary outcomes:
measure: Overall Response Rate
timeFrame: up to 36 months
measure: Partial remission or complete remission
timeFrame: up to 36 months
Secondary outcomes:
measure: Disease Free Survival
timeFrame: up to 36 months
measure: Progression Free Survival
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT06158893: Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy
Official title: Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 87
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy

Detailed description: Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy Adenotosillectomy is routinely performed for children with sleep disordered breathing or recurrent infectious tonsillitis. Although the safety of the pediatric anesthesia is constantly improving, a substantial proportion of children undergoing tonsillectomies experience pre operative respiratory adverse events with a prevalence up to 50% in children with at least one risk factor. Both minor adverse effects such as oxygen desaturation airway, obstruction coughing or wheezing and the major events such as laryngospasm and/ or bronchospasm occur more commonly undergoing tonsillectomy compared with other non airway surgery.

Eligibility criteria: Inclusion Criteria:

1. children scheduled for elective tonsillectomy with or without adenoidectomy, grommets cautery of inferior turbinates.
2. Age more than or equal 5 years and less than or equal to 12 years.
3. Both genders
4. No obvious abnormalities in preoperative ECG, blood routine electrolytes and other tests.
5. ASA class 1

Exclusion Criteria:

1. Patients with Known hypersensitivity to any of the drugs that would be used in the study
2. Patients that are immunologically compromised
3. Sleep apnea syndrome or difficult airway
4. Pre-existing hypoxemia is SpO2 \< 90%
5. History of adverse events with prior sedation or patients who had taken any sedative drugs within the last 24 hours.
6. Parents refusal

Primary outcomes:
measure: incidence of preoperative respiratory adverse events.
timeFrame: 1 year
Secondary outcomes:
measure: frequency of the individual PRAEs
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01433393: Double-blind Comparative Study of TAK-875
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 192
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.

Primary outcomes:
measure: HbA1c
Secondary outcomes:
Other outcomes:
Locations:
city: Kisarazu-shi
country: Japan
state: Chiba
city: Matsuyama-shi
country: Japan
state: Ehime
city: Fukuoka-shi Nishi-ku
country: Japan
state: Fukuoka
city: Kasuga-shi
country: Japan
state: Fukuoka
city: Naka-shi
country: Japan
state: Ibaragi
city: Tsuchiura-shi
country: Japan
state: Ibaragi
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Kyoto-shi Fushimi-ku
country: Japan
state: Kyoto
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Kashihara-shi
country: Japan
state: Nara
city: Kashiwara-shi
country: Japan
state: Osaka
city: Osaka-shi Tsurumi-ku
country: Japan
state: Osaka
city: Sakai-shi Nishi-ku
country: Japan
state: Osaka
city: Shimotsuke-shi
country: Japan
state: Tochigi
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
Study officials:
References:
Clinical trial NCT04249193: Pulse Oximetry Measurement and Transfusions
Official title: Effect of Blood Transfusions on Intermittent Hypoxic Episodes in Very Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia Neonatal
Premature
Blood Transfusion
Keywords: Transfusion
Intermittent hypoxia
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Temple University Hospital
name: University of Pennsylvania
name: Pennsylvania Hospital
First posted: 2020-01-30
Enrollment: 75
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature neonates

Brief summary: The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.


Eligibility criteria: Inclusion Criteria:

* 23+0 to 28+6 weeks gestational age at birth

Exclusion Criteria:

* Infants with life-limiting diagnoses
* Cyanotic heart disease
* In utero fetal transfusion
* Twin to twin transfusion syndrome
* Isoimmune hemolytic disease
* Severe acute hemorrhage
* Acute shock
* Sepsis with coagulopathy
* Need for perioperative transfusion
* Parents opposed to transfusion of blood
* Parents with hemoglobinopathy or congenital anemia

Primary outcomes:
measure: Change in number of Intermittent hypoxia
timeFrame: Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).
Secondary outcomes:
measure: Hypoxia
timeFrame: 8 hours prior to transfusion and 8 hours after transfusion.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Christiana Care Health Services, Inc
name: Kelley Z Kovatis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03014193: Simplifying First Trimester Medical Abortion Follow-up
Official title: Simplifying First Trimester Medical Abortion Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women seeking medical abortion with pregnancies of 63 days or less.

Brief summary: This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.


Eligibility criteria: Inclusion Criteria:

* Have a first trimester pregnancy with a gestational age of ≤63 days;
* Desire medical abortion with mifepristone and misoprostol and be medically eligible for that treatment, according to clinic protocol;
* Be able to read and understand the local language or Russian;
* Have access to a telephone;
* Agree to follow all study procedures;
* Have no contraindication to participation in the study, in the judgment of the site investigator or designee.

Primary outcomes:
measure: Understanding of the instructions for the multilevel pregnancy test
timeFrame: 14 days
measure: Ability to independently use the multilevel pregnancy tests
timeFrame: 14 days
measure: Ability to interpret the results of the multilevel pregnancy test
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gyumri
country: Armenia
facility: Gyumri Maternity Hospital
city: Yerevan
country: Armenia
facility: Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
city: Batumi
country: Georgia
facility: Batumi International Hospital
city: Tbilisi
country: Georgia
facility: David Gagua Clinic
city: Almaty
country: Kazakhstan
facility: City Policlinic #17
Study officials:
References:
Clinical trial NCT02292693: Direct Laryngoscopy During Cervical Trauma
Official title: Comparison Three Different Laryngoscope Blades for Endotracheal Intubation in Pediatric Patients With Cervical Spine Immobilization.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Keywords: intubation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 80
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: TREATMENT

Brief summary: The aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Intubation time
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
measure: Preferred ETI device
timeFrame: 1day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04256993: PRECISE, a Study to Gather More Information About Bone Fractures and Survival in Castration-resistant PRostate Cancer (CRPC) patiEnts Treated With Radium-223 in Routine Clinical practIce in SwedEn
Official title: Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) PatiEnts Treated With Radium 223 in Routine Clinical practIce in SwedEn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: Prostate cancer metastatic
Prostate cancer
Bone fractures
Overall survival
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 1434
Sex: MALE
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: The study population comprises men with mCRPC in the PPC (Patient-overview Prostate Cancer) PCBaSe data set during the study time frame, with the potential addition of men with mCRPC in the Karolinska Institutet data sets.

Brief summary: In this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. The goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the NPCR (histology other than adenocarcinomas are not registered in the NPCR).
* Start of Ra-223 treatment for mCRPC as an n-th line of treatment, where "n" goes from 1 to 4.
* ECOG performance status of 0-2 at treatment initiation. We will assume that patients starting any of the systemic therapies under study have a performance status of 0-2.

Exclusion Criteria:

* Prior use of Ra-223
* Patients that have participated in a Ra-223 RCT

Primary outcomes:
measure: Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
timeFrame: Retrospectively analysis from November 2013 to December 2018
Secondary outcomes:
measure: Death due to all causes
timeFrame: Retrospectively analysis from November 2013 to December 2018
measure: Death due to prostate cancer
timeFrame: Retrospectively analysis from November 2013 to December 2018
Other outcomes:
Locations:
city: Database Study
country: Sweden
facility: Database Study
Study officials:
References:
Clinical trial NCT04110093: Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer
Official title: The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Immunotherapy
Keywords: Colorectal Cancer
Immunotherapy
Regorafenib
Nivoluamb
microsatellite stable
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC).


Eligibility criteria: Inclusion Criteria:

* Advanced Colorectal Cancer diagnosed histologically;
* Patients with microsatellite stable (MSS)
* Patients have no any standard choice after multiple line of therapy( ≥ 2 lines);
* Expected survival ≥ 3 month;
* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

* Patient still has standard treatment therapy based on NCCN guidance;
* Patient can not comply with research program requirements or follow-up;

Primary outcomes:
measure: Objective Response Rate
timeFrame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
measure: Progress Free Survival
timeFrame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
measure: Adverse Effect
timeFrame: Through study completion, an average of 1 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Medical Oncology, Shanghai Changzheng Hospital
Study officials:
References:
Clinical trial NCT06525493: Comparison of Combination of Proximal ACB and iPACK With Large-Volume Distal ACB for Early Mobilization After TKR
Official title: Comparison of Combination of Proximal Adductor Canal Block and Infiltration Between Popliteal Artery and Capsule of Knee With Large-Volume Distal Adductor Canal Block in Facilitating Early Mobilization After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adductor Canal Block
Postoperative Pain
Regional Anesthesia
Keywords: Total Knee Replacement
Adductor Canal Block
Postoperative Pain
Regional Anesthesia
Postoperative Mobilization
TUG Test
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

Detailed description: Adductor Canal Block (ACB) and Infiltration between Popliteal Artery and Capsule of Knee (iPACK) are popular block methods for analgesia after Total Knee Replacement (TKR), covering both anterior and posterior knee. Adductor canal serves as a passageway, local anesthetic injected here will spread both to proximal and distal to posterior. Study was a single-blinded, randomized controlled trial between June 2023 and January 2024. Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

Eligibility criteria: Inclusion Criteria:

* Patients aged 50 - 80 years who underwent total knee replacement surgery

Exclusion Criteria:

* Systemic allergy, anaphylactic reaction, and occurrence of cardiac arrest
* Intraoperative fracture
* Change to general anesthesia
* Patient who decides to withdraw from the study.

Primary outcomes:
measure: Timed Up and Go test on Postoperative Day 1 (POD 1)
timeFrame: The test is conducted specifically on the first day after the surgery, known as Postoperative Day 1 (POD 1)
measure: Numeric Rating Scale
timeFrame: The NRS assessments are conducted at 6 hours, 12 hours, and 24 hours after the surgery
measure: Total 24 hours morphine consumption
timeFrame: The measurement is taken over the entire 24-hour period following the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, Indonesia
state: DKI Jakarta
Study officials:
References: