louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06395805: Evaluation of Quality of Life and Self-assurance and Social Support Earned for Non-cellular Head Cancer
Official title: Evaluation of Quality of Life and Self-assurance and Social Support Earned in Patients Before and After Operation for Non-cellular Head Cancer and Cancer in the First, Second and Third Stages of Advance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head Cancer
Lead sponsor: Andrzej Frycz Modrzewski Krakow University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each patient who is admitted to the surgical ward with a diagnosis of head cancer will be qualified for surgery will be given written consent for the study and the processing of personal data, as well as information for the researcher with questionnaires, and then give written consent will be recruited for the study. The patient's personal data processing information will be retained for the study until its completion.

Brief summary: Research objectives:

* To evaluate the quality of life of patients before and after surgery for benign head tumors ( meningiomas) and malignant tumors at stage I, II and III, to assess whether it depends on the size of the tumor, type of tumor, malignancy and its location
* evaluation of the independence of patients before and after surgery for head tumors at different stages of the disease - benign tumors (meningiomas) and malignant tumors in stage I, II and III, evaluation of what factors affected the different independence of patients
* Multidimensional evaluation of perceived social support of patients before and after surgery for head cancers - benign ( meningiomas) and malignant tumors in stage I, II and III, taking into account three sources of support: significant person, family and friends

Scientific (research) problems:

- What is the quality of life of patients before and after surgery for benign ( meningiomas) and malignant head cancers at stages I, II and III ? Is quality of life in patients with head cancer dependent on tumor size, malignancy, location or type of cancer ?


Eligibility criteria: Inclusion criteria for the study:

-clinical diagnosis of head cancer

Study exclusion criteria:

- cranio-brain injuries and inflammatory brain diseases.

Primary outcomes:
measure: Quality of life assessed using The World Health Organization Quality of Life (WHOQOL) scale. Social support assessed using Zimet's Multidimensional Perceived Social Support Scale. Patient self-efficacy as assessed by the Lawton I-ADL scale and AIS scale.
timeFrame: 12 months to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: St. Raphael's Hospital
state: Lesserpoland
Study officials:
References:
Clinical trial NCT06199505: A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
Official title: A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-01-10
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
* BMI = 18.5-35 kg/m2 (inclusive) at screening.
* Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
* 7.0% ≤ HbA1c ≤ 11.0% at screening.

Exclusion Criteria:

* Women in pregnancy or lactation.
* Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
* Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
* Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
* Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
* Known or suspected hypersensitivity to trial product(s).
* Participation in a clinical study of another study drug within 1 month prior to randomization.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 16
measure: The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16
timeFrame: Week 16
measure: Incidence and Rate of hypoglycemia Events
timeFrame: Baseline to Week 16
measure: Incidence and Rate of Treatment-emergent AE/SAEs
timeFrame: Baseline to Week 16
measure: Change from baseline in ADA and Nab
timeFrame: Baseline to Week 16
Other outcomes:
measure: Change from Baseline in Body Weight
timeFrame: Baseline to Week 16
Locations:
city: Beijing
country: China
facility: Gan & Lee Pharmaceuticals Co., Ltd
state: Beijing
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Chunyue Hao, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03165305: The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
Official title: The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Transient Tachypnea of the Newborn
Respiratory Morbidity
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 200
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.


Eligibility criteria: Inclusion Criteria:

* term newborns
* parental informed consent
* inborn infants

Exclusion Criteria:

* major congenital/chromosomal abnormalities
* lack of informed consent
* outborn infants
* Premature infants

Primary outcomes:
measure: Respiratory Morbidity
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
name: Merih Cetinkaya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01959997: Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI
Official title: Randomized Comparison of Redo Pulmonary Vein Isolation With vs. Without Renal Denervation for Recurrent Atrial Fibrillation After Initial Pulmonary Vein Isolation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Fibrillation
Arterial Hypertension
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the elimination of atrial fibrillation in patients with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when undergoing repeat PVI (control) vs repeat PVI plus renal denervation.


Eligibility criteria: Inclusion Criteria:

* Prior PVI ablation procedure for paroxysmal AF within past 2 years
* Recurrent symptomatic paroxysmal AF despite prior PVI
* History of essential hypertension requiring at least 2 chronic antihypertensive medications

Exclusion Criteria:

* Persistent AF after prior ablation
* Congestive heart failure (NYHA III-IV functional class)
* Left ventricle ejection fraction \< 35%
* Left atrial diameter \>55 mm
* An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
* Renal arteries unsuitable for RDN:

  1. Inability to access renal vasculature
  2. Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
  3. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
  4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
  5. Multiple main renal arteries to either kidney
* Unwillingness to participate

Primary outcomes:
measure: The absence of AF
timeFrame: 1 year
Secondary outcomes:
measure: Systolic and diastolic blood pressures
timeFrame: 1 year
measure: procedural duration and complications
timeFrame: 1 year
measure: LV mass on echocardiogram
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: University of Rochester
name: Jonathan S. Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01966497: Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia
Official title: Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloblastic Leukemia
Aged Higher Than 60 Years Old
Keywords: AML
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital admissions from the participating centres

Brief summary: The main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. In this age group (aged more than 60y), three groups of patients with very different response rates and late outcome can be delineated with specific standard chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Aged 60 years or more
* With a morphologically proven diagnosis of AML according to WHO 2008 classification
* Not previously treated for AML
* Signed informed consent.

Exclusion Criteria:

* APL in the WHO classification.
* Ph1-positive AML or prior Ph1-positive disease
* AML evolving from a prior MPN in the WHO 2008 classification.
* Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
* ECOG Performance Status Score \> 3
* Positive serology for HIV or HTLV1, or active viralinfection for HBV and HBC.
* Severe uncontrolled infection at inclusion time.
* Psychiatric disease or an history of non-complianceto medical regimens or patients considered potentially unreliable.
* Absence of Health Care Insurance

Primary outcomes:
measure: cumulative incidence of failures
timeFrame: 9 months
Secondary outcomes:
measure: response rate
timeFrame: 9 months
measure: relapse rate
timeFrame: within 2 years after inclusion
measure: overall survival
timeFrame: within 2 years after inclusion
measure: adverse events
timeFrame: within 2 years after inclusion
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Avicenne
state: Ile De France
Study officials:
References:
citation: Gardin C, Pautas C, Fournier E, Itzykson R, Lemasle E, Bourhis JH, Ades L, Marolleau JP, Malfuson JV, Gastaud L, Raffoux E, Lambert J, Braun T, Thomas X, Chantepie S, Cluzeau T, de Botton S, Berthon C, Boissel N, Duployez N, Terre C, Peffault de Latour R, Michallet M, Celli-Lebras K, Preudhomme C, Dombret H. Added prognostic value of secondary AML-like gene mutations in ELN intermediate-risk older AML: ALFA-1200 study results. Blood Adv. 2020 May 12;4(9):1942-1949. doi: 10.1182/bloodadvances.2019001349.
Clinical trial NCT07009197: Effect of Instrument Assisted Soft Tissue Mobilization on Hand Post Surgical Scars in Primary Flexor Tendons Repair in Zone v
Official title: Effect of Instrument Assisted Soft Tissue Mobilization on Hand Post Surgical Scars in Primary Flexor Tendons Repair in Zone v
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Injuries
Keywords: Instrument Assisted Soft Tissue Mobilization
Primary Flexor Tendons Repair
Hand Post Surgical Scars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: instrumented assisted soft tissue mobilization and tradional therapy
Primary purpose: TREATMENT

Brief summary: this study will be conducted to investigate the effect of instrument assisted soft tissue mobilization on hand post surgical scars in primary flexor tendons repair in zone v

Detailed description: The hand plays an important role in independent daily living and in communication with the environment. As the most mobile part of the upper extremity, the hand is actively used in everyday life and professional fields. The flexor tendons of the hand are critical for normal hand function. Injury to these tendons can result in absent finger and wrist flexion, and a subsequent loss of overall hand function. The surgical techniques used to repair these tendons have improved in the past few decades, as have the postoperative rehabilitation protocols. In spite of these advances, flexor tendon repairs continue to be plagued by postoperative scar formation, which limits tendon gliding and prevents a full functional recovery. Many different treatment methods can reduce the trauma and surgical scars. Manual scar treatment is one of these methods. Manual scar therapy to be effective requires applying physiological stimuli adequately to the phase of wound healing. Scar tissue therapy is a treatment for reducing pain and functional limitations, improving pliability, reducing hyper-pigmentation, pruritus, fascial adhesions, to reduce scar thickness and smooth surface area. Instrument assisted soft tissue mobilization (IASTM) is a soft-tissue treatment technique where an instrument is used to provide a mobilizing stimulus to positively affect scar tissue and myofascial adhesion.

Eligibility criteria: Inclusion Criteria:

* Both sex will be included in this research
* Hand scar in zone v
* Age varying from 20 to 40
* Hand scar formed post primary flexor tendons repair

Exclusion Criteria:

* Vascular injuries requiring arterial repair
* Soft tissue loss
* Fractures
* Tendon in-juries of other zones
* Preexisting problems such as arthritis limiting joint motion
* unhealed wounds or age of scar under 6 weeks

Primary outcomes:
measure: scar assessment
timeFrame: up to four weeks
Secondary outcomes:
measure: range of motion
timeFrame: up to four weeks
measure: handgrip strength
timeFrame: up to four weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06152497: The Role of Histamine in Muscle Protein Synthesis Following Resistance Training
Official title: The Role of Histamine in Muscle Protein Synthesis Following Chronic Resistance Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Histamine
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2023-11-30
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups
Primary purpose: BASIC_SCIENCE

Brief summary: Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses the following research question: "What is the influence of histamine H1 signaling on training adaptations following ten weeks of resistance training in human skeletal muscle." Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.


Eligibility criteria: Inclusion Criteria:

* Male
* 18-45 years
* Not to medium physically active

Exclusion Criteria:

* Smoking
* Chronic disease
* High blood pressure
* Supplement or medication intake
* Seasonal allergies
* Vegetarian / vegan
* Resistance trained

Primary outcomes:
measure: Muscle volume
timeFrame: Before and after the 10 weeks of resistance training
measure: Maximal dynamic strength of leg press, bench press, bicep curl and leg curl
timeFrame: Before and after the 10 weeks of resistance training
measure: Muscle fiber hypertrophy in muscle biopsies
timeFrame: Before and after the 10 weeks of resistance training
measure: Matsuda index, to estimate whole body glucose metabolism, will be calculated using an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood will be measured before and after drinking 75g glucose)
timeFrame: Before and after the 10 weeks of resistance training
measure: Vascular function measured with a single passive leg movement (sPLM: change in femoral blood flow measured with Doppler ultrasound before and after one passive flexion/extension of the leg)
timeFrame: Before and after the 10 weeks of resistance training
Secondary outcomes:
measure: Blood pressure (systolic and diastolic)
timeFrame: Before and after the 10 weeks of resistance training
measure: Resting heart rate
timeFrame: Before and after the 10 weeks of resistance training
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of movement and sports sciences, Ghent University, Belgium
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Wim Derave, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00310297: Insulin Glulisine in Type 2 Diabetes Mellitus
Official title: A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary objective:

To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.

Secondary objectives:

* To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
* The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.


Eligibility criteria: Inclusion criteria :

* Type 2 diabetes mellitus
* Body mass index (BMI) between 35 and 40 kg/m2
* HbA1c ≤10%
* Plasma C-peptide levels ≥0.1 nmol/L.
* Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.

Exclusion criteria :

* Type 1 diabetes mellitus, as defined by the World Health Organization
* Subjects currently taking any insulin
* History of hypoglycaemic unawareness
* Injection site skin thickness \< or = 8 mm
* Contra-indications from

  * The medical history and physical examination
  * Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick)
  * Blood pressure and pulse

Primary outcomes:
measure: Maximum plasma glucose concentration (GLUmax, mmol/L)
timeFrame: During the Study Conduct
measure: Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
timeFrame: during the study conduct
measure: Time to GLUmax (Tmax, min)
timeFrame: during the study conduct
Secondary outcomes:
measure: Area under the insulin concentration-time curve after injection(μIU.min/mL)
timeFrame: between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h)
measure: Maximum concentration (Cmax, μIU/mL)
timeFrame: During the study conduct
measure: Adverse events collection
timeFrame: from the inform consnet signed up to the end of the study
measure: Time to maximum concentration (Tmax, min)
timeFrame: During the study conduct
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Valérie Pilorget, MD
role: STUDY_DIRECTOR
References: