louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02847663: The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial
Official title: The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cold
Keywords: Cold
recovery
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: THIM - die internationale Hochschule für Physiotherapie
name: Vrije Universiteit Brussel
First posted: 2016-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after a muscle damage protocol.

Detailed description: In this study the effects of a single- or multiple whole body cryotherapy (-135°C for max. 2 minutes) vs. cold water immersion (10°C for 15 min) and a passive control group (20 min supine position) are compared. These effects are examined after a muscle damage protocol of the frontal thighs (3 x 30 jumps). The objective recovery parameters are vertical jump, maximum voluntary contraction of the anterior thigh muscle, heart rate, blood pressure, skin-core body temperature and the oxygen saturation of the thigh muscles. Subjective recovery parameters are the local muscle soreness details and the general exhaustion details. The parameters are directly and 24, 48 and measured 72 hours after exposure. The aim is to elicit the effects of whole body cooling to make recommendations to. The current scientific knowledge situation calls for further studies to whole body cooling.

Eligibility criteria: Inclusion Criteria:

Only healthy young subjects 18-35 years no musculoskeletal surgery in trunk and lower extremities injury history in trunk and lower extremity for more than one year subjects taking anticonceptive medication are allowed to participate

Exclusion Criteria:

Actual injuries or injuries for less than one year in trunk and /or lower extremities injury history in trunk and lower extremity for more than one year with complaints anxiety of cooling subjects on medication pace maker cardiovascular disease pregnancy skeletal problems appendectomy for less than two years Morbus Raynaud syndrome

Primary outcomes:
measure: Vertical Jump
timeFrame: 72 hours
measure: Maximum voluntary contraction
timeFrame: 72 hours
measure: Delayed onset of muscle soreness
timeFrame: 72 hours
measure: Ratings of perceived exertion
timeFrame: 72 hours
measure: Skin temperature
timeFrame: 60 minutes
measure: Core temperature
timeFrame: 60 minutes
measure: Cardiovascular measurements
timeFrame: 60 min
measure: Oxygenation of the right thigh muscle
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: Fachhochschule Südschweiz
Study officials:
affiliation: Fachhochschule Südschweiz
name: Ronaldus Clijsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564563: Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
Official title: A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Bleeding During/Following Surgery
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone a hematopoietic stem cell transplantation

Exclusion Criteria:

* Known or suspected allergy to trial product
* Participation in other trials with unapproved drugs or trials with equal or similar objective

Primary outcomes:
measure: Effect on bleeding, defined as change in bleeding score
Secondary outcomes:
measure: Transfusion requirements
measure: Bleeding evaluation
measure: Adverse events
measure: Changes in safety coagulation parameters
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Duarte
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06397963: Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients with Solid Tumours
Official title: A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients with Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor, Adult
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Eligibility criteria: Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
* 2. Age 18 to 70 years old;
* 3. Patients with advanced solid tumours who have been diagnosed with: failure of standard treatment, no standard treatment, or inaccessible to standard treatment;
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 12 weeks;
* 6. Good function of vital organs;
* 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
* 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment

Primary outcomes:
measure: Incidence and severity of adcersed events per CTCAE 5.0
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Gobroad hospital
state: Beijing
city: Xuzhou
country: China
facility: The Affiliated Hospital Of Xuzhou Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT05650463: Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
Official title: Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: Stockholm South General Hospital
First posted: 2022-12-14
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP

Detailed description: To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.

Eligibility criteria: Inclusion Criteria:

* Infants born with gestational age ≥ 37
* Birth weight ≥ 2500g
* Age 1 - 14 days
* Will have a blood sample performed, either for clinically suspected jaundice or newborn screening sample

Exclusion Criteria:

* Infants showing signs of inborn disease
* Infants transferred to pediatric ward for treatment
* Infants that have received phototherapy

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of Picterus-generated estimate with TsB
timeFrame: 1-2 hours
measure: Comparison of Picterus-generated estimate with TcB
timeFrame: 5-10min
measure: Comparison of Picterus-generated estimate with visual assessment.
timeFrame: 5-10min
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Picterus AS
name: Lobke Gierman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00221663: Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
Official title: Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Heart Valve Diseases
Keywords: Cardiac surgery
Aortic valve replacement
Minimally invasive surgery
Perioperative course
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.

Detailed description: Background:

Minimally invasive techniques for cardiac surgery should be formally evaluated.

Design:

Randomized, single-blind, monocentric trial.

Interventions Compared:

Median sternotomy versus minimally invasive technique.

Eligibility Criteria:

Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class \< = 3, left ventricular ejection fraction \> = 40%.

Primary Outcome:

Forced expiratory volume and peak expiratory volume/second at 48 hours.

Eligibility criteria: Inclusion Criteria:

* Indication of isolated aortic valvular replacement
* Preoperative ASA class \< = 3
* Left ventricular ejection fraction \> = 40%
* Signed informed consent

Exclusion Criteria:

* Aortic or mitral insufficiency \> 3
* History of cardiac surgery
* Acute pulmonary edema
* Endocarditis
* Chronic renal insufficiency decompensation
* Operative coagulation disorders regardless of etiology

Primary outcomes:
measure: Forced expiratory volume and peak expiratory volume/second
timeFrame: at 48 hours
Secondary outcomes:
measure: Forced expiratory volume
timeFrame: at 24 hours
measure: Peak expiratory volume/s at 24 hours
measure: Pro-inflammatory cytokines on tracheal aspiration samples
measure: Transfusion requirements during the first 24 hours post operative
measure: Hemodynamic parameters
measure: Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
measure: Consumption of analgetics
measure: Morbidity and mortality during hospital stay
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut Lévêque
Study officials:
affiliation: University Hospital, Bordeaux
name: Gerard Janvier, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux France
name: Joachim Calderon, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux France
name: Geneviéve Chene, Pr
role: STUDY_CHAIR
References:
Clinical trial NCT01065363: Health Promotion and Management for Hepatitis B Carriers
Official title: Project of Health Promotion and Management for Hepatitis B Carriers in NTU Campus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B virus DNA
Metabolic factor
Body mass index
Obesity
Insulin resistance
Lifestyle factor
Preventive Medicine
Health Promotion
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2010-02-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators propose a project of preventive medicine with concern of local context in Taiwan. The target population includes all staff and faculty members, students, and alumni of a university in Northern Taiwan, with chronic hepatitis B infection. The intervention of this project includes standardized lectures, sports courses, nutrition courses, and an information platform. The investigators will evaluate the efficacy after the intervention, like the reduction of hepatitis B viral load and the associated anthropometric parameters. The results of this project will be initially served as a pilot study for this cohort, and applicated as a promising basis for health promotion.


Eligibility criteria: Inclusion Criteria:

* Participants were recruited from students, alumni, faculty and staff members with chronic HBV infection (positive HBsAg serostatus ≥6 months) in a university of northern Taiwan from August 1, 2009 to July 01, 2010. Only participants aged 18 and older were included.

Exclusion Criteria:

* Excluded were:

  * (a) those who had been diagnosed as chronic liver diseases like chronic hepatitis C infection (Anti-HCV (+)), autoimmune hepatitis, Wilson disease, alcoholic liver diseases, drug-related hepatitis, decompensated liver diseases, cirrhosis, or malignant hepatic tumors;
* (b) those who had undergone liver transplantation or major operations for liver except cholecystectomy;
* (c) men who consumed more than 30 gram of alcohol per week or women who consumed more than 20 gram of alcohol per week;
* (d) women who were pregnant;
* (e) those who had current medications for any types of chronic diseases except for hyperglycemia, elevated blood pressure, or dyslipidemia within six months.

Primary outcomes:
measure: Reduction of relative serum HBV DNA levels
timeFrame: three months
Secondary outcomes:
measure: anthropometric index
timeFrame: three months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Health Center
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation
name: Jin-Shin Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01660763: Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
Official title: P3 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Pain
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 419
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: The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female patients who are 18 years of age or older
* Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid
* Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery

Exclusion Criteria:

* Patients who have undergone a replacement of the same knee or hip
* Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet)
* Patients with an allergy or hypersensitivity to opioids

Primary outcomes:
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: United States
facility: Deidre Stonestreet
state: Maryland
Study officials:
affiliation: Chief Medical Officer, AcelRx Pharmaceuticals, Inc.
name: Pamela Palmer, M.D., PhD
role: STUDY_DIRECTOR
References:
citation: Jove M, Griffin DW, Minkowitz HS, Ben-David B, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study. Anesthesiology. 2015 Aug;123(2):434-43. doi: 10.1097/ALN.0000000000000746.
Clinical trial NCT06439563: Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
Official title: A Multicenter, Parallel, Double-blind, Randomized, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 Treatment in the Prevention of (NSAIDs)-Induced Peptic Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Peptic Ulcer
Lead sponsor: Onconic Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 364
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg.


Eligibility criteria: Inclusion Criteria:

1. Adult male/female aged 19 years or older as of the date of obtaining consent
2. Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more
3. Those with one or more of the following risk factors for ulcer development at the time of screening
4. Subjects who fully understand this study and voluntarily signed the informed consent form.

Exclusion Criteria:

1. Those who cannot undergo upper gastrointestinal endoscopy
2. At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification\*
3. Those with a confirmed history of malignant tumor within 5 years
4. Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
5. Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
6. Pregnant and lactating women or those with a positive pregnancy test result at screening
7. Those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(Visit 0)

Primary outcomes:
measure: Cumulative proportion of subjects who developed peptic ulcers
timeFrame: at 24 weeks after administration of investigational products
Secondary outcomes:
measure: Proportion of subjects with gastric or duodenal endoscopic bleeding
timeFrame: at 24 weeks after administration of investigational products
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References: