cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA)

The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure, pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide synthesis in healthy subjects.

Tolvaptan is a vasopressin antagonist (V2-antagonist) and is used in treatment of hyponatremia. Animal studies have demonstrated that inhibition of V2 receptors in the renal principal cell increases renal free water clearance and renal sodium excretion.

Treatment with V2-receptor antagonists increases vasopressin concentration in plasma that stimulates V1-receptors in the vascular bed. This may change both central and peripheral hemodynamics and plasma concentration of vasoactive hormones. Changes in hemodynamics and hormone concentration may consequently change renal sodium and water handling.

The nitric oxide system plays a central role in both renal sodium and water handling and regulation of vascular tone and blood pressure.

The effects of tolvaptan the circulation and kidneys is investigated by using measurements of biomarkers specific for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of tolvaptan and L-NMMA infusion.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 18-40 years
* Body Mass Index (BMI) 18,5-30 kg/m2

Exclusion Criteria:

* Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
* Neoplastic disease
* Drug abuse
* Alcohol abuse
* Medical treatment except peroral anticontraceptive
* Pregnancy
* Smoking
* Abnormal blood and urine sample
* Abnormal ECG
* Blood donation within a month before examination
* Arterial hypertension (\>140 mmHg systolic and/or 90 mmHg diastolic)
Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer

The purpose of this study is to evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.

The primary objective of this 110 patient correlative biomarker study is to evaluate whether changes in mutant ESR1 allele fraction in plasma circulating tumor DNA (ctDNA) are predictive of progression-free survival in metastatic ER+ breast cancer patients who are receiving 2nd, 3rd, or 4th line systemic endocrine therapy. A secondary goal of this study is to explore the prevalence and kinetics of hotspot and non-hotspot ctDNA ESR1 mutations in this patient population, prior to initiating a new line of endocrine therapy as well as upon clinical progression, to identify potential mechanisms of resistance. Although initially to be opened at UNC Chapel Hill, our goal is to expand enrollment to include Rex Cancer Center in Raleigh, North Carolina, and collaborating institutions through the Translational Breast Cancer Research Consortium.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Female gender
* Biopsy proven diagnosis of breast cancer
* Stage IV disease diagnosed either by radiographic studies or biopsy
* ER+ by immunohistochemistry on primary and/or metastatic tissue biopsy (\>10%)
* HER2 non-amplified (1+ or below by immunohistochemistry, and/or Her2 FISH \<2 HER2-to-CEP17 ratio)
* Progressed on at least one prior line of endocrine therapy for metastatic disease
* Three or fewer prior endocrine-containing therapies for recurrent/metastatic disease
* Two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease
* Plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease
* Recent re-staging scans within 4 weeks of study enrollment, with radiographically identifiable disease
* No concurrent or prior diagnosis of malignancy other than breast cancer for the past 5 years. Patients with a history of in situ cancer or basal or localized squamous cell skin cancer remain eligible
* Intends to pursue treatment as well as clinical and radiographic follow-up at UNC Health Care
* Signed an institutional review board (IRB)-approved informed consent document for this protocol and HIPAA consent form

Exclusion Criteria:

* \< 18 years of age
* Tissue biopsies that support the presence of both ER+ and ER- metastatic breast cancer in the same patient
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
* Pregnant or lactating women
Quality Improvement of Person-Centered Care for Maternal Health in Public Facilities in India, Phase 2

Evaluating the spread of a quality improvement (QI) change package working to improve person-centered care (PCC) for maternal health (MH) services.

After implementing a quality improvement (QI) collaborative in public facilities in Uttar Pradesh, India, a second phase was done to evaluate if the "change package" developed during phase one could be implemented in similar facilities to improve the quality of person-centered care (PCC) for a maternal health (MH) services.

Eligibility Criteria:
Inclusion Criteria for Women:

* Women aged 18-49 years old
* Who agreed to participate
* Who delivered a baby at the facility where data collection is taking place within the last 7 days

Exclusion Criteria for Women:

* Not a women aged 18-49
* Did not agree to participate
* Did not deliver a baby at the facility where data collection is taking place within the last 7 days

Inclusion Criteria for Providers:

* Agreed to participate
* Purposive sampling
* Permanent staff at the facility

Exclusion Criteria for Providers:

* Did not agree to participate
* Not permanent staff at the facility
Clinical Investigation to Evaluate the Performance of Hyaluronic Acid for the Treatment of Hypertrophic Scars

The study includes two study groups, one involves treatment with auto-cross-linked Hyaluronic acid by intralesional and hypodermic injection, repeated after two weeks (T14), while the control arm provides an equal treatment but with isotonic saline solution.

Enrolled patients will be randomized into 2 groups with an allocation of 2:1 in study treatment arm and control arm respectively. They will be evaluated using the POSAS scale before the treatment and re-evaluated at 30, 90 and 180 days after treatment.

The scar evaluation will be completed by an ultrasound assessment at time 0 (T0), 30 (T30), T90 and T180 and the DLQI (Dermatology Life Quality Index) to be assessed at time 0 (T0), 30 (T30), 90 (T90) and 180 (T180).

In subjects that will consent, a small surgical biopsy for an explorative evaluation of the scar tissue will be performed before (T0) and after treatment (T30) for a histological assessment.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male or female subjects aged ≥ 18 and ≤ 85 years
* Subjects with hypertrophic scars caused by trauma, burn or iatrogenic injury with or without involvement of the mobile joints
* Scar \> 2 to \< 25 cm2 of surface
* Scar not previously treated with corticosteroids, laser or other invasive treatments
* Scar present for at least 12 months
* Scar located in all areas of the body with the exception of the face and neck
* Fitzpatrick skin score of I-VI
* Subjects willing to comply with all the steps of treatment and follow-up visits
* Subjects willing to refrain from any cosmetic intervention in the area to be treated during the clinical investigation
* Female of child-bearing potential (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first treatment

Exclusion Criteria:

Subjects with type I and type II diabetes mellitus

* Subjects with oncological diseases in progress or in remission
* Subjects receiving immunosuppressive drugs and corticosteroids, anticoagulants, antiplatelet agents
* Subjects with autoimmune diseases including connectivitis
* Subjects with congenital or acquired immunodeficiencies (including metabolic ones)
* Subjects with known allergy or hypersensitivity to hyaluronic acid or its derivatives
* Participation in clinical trials/investigations in the last 30 days
* Pregnant or breastfeeding women
* If female and of child-bearing potential, subject not using a highly effective method of birth control and not willing to use it during the participation to the clinical investigation
* Subjects not willing to avoid tanning during the clinical investigation
* Subjects with inflammations of the skin, including rosacea
* Subject with skin infection in the area to be treated
* Subjects having a high probability of non-compliance with the study procedures according to Investigator's judgement
Early Physical Therapy in Patients With Sepsis

It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or multi organic failure are very susceptible to develop neuromuscular complications. That can be attributed to a hyper catabolic state, general inflammation and immobilization. This can leads a significant muscle wasting, polyneuropathy and/or myopathy. These alterations have been defined with the term Intensive Care Acquired Weakness (ICUAW) and can leads important functional squeals and impaired quality of life for months, years and in some cases irreversibly.

To overcome these complications, early activation by physiotherapy becomes an important tool. This type of treatment has been show to be feasible, safe and improves the functional capacity of patients. In addition to a reduction in the duration of ICU and hospital stay and improved quality of life for patients.

The objective of this study is to demonstrate that the early and active physical activity in patients with severe sepsis can limit the loss of muscle mass and complications related to this type of damage.

Procedures: Patients or relatives will be asked to participate in the study. If a positive response is done, patients will be randomized in an intervention or control group.

A baseline evaluation will be performed during the first day of study admission. That includes a physical exploration, electrophysiological studies, skeletal muscle histological/biochemical evaluations and monitoring of blood biomarkers and others clinical outcomes will be registered.

Intervention will be divided in a morning and afternoon times, patient will be positioned in chair or bed and mobilized by physiotherapist. As usual, all patients will be attaining manual mobilization for 20 minutes twice a day. Only for intervention group, additional cycle-ergometer exercise will be performed for 30 minutes at better performance achieved and tolerated for patient. All vitals parameters will be strictly controlled before, during and after intervention.

The same baseline evaluation will be repeated after day 7 and clinical outcomes will be registered until ICU discharge.


Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable patients.
* Admitted to ICU for sepsis or MOF (multiple organ failure) or who developing during their ICU stay within the first 24 hours of the ICU admission.
* With an expected ICU stay of at least 7 days.

Exclusion Criteria:

* Patients without approved consent.
* Patients with a known neuromuscular disorder before ICU admission.
* Moribund patients.
* Severe metabolic/hemodynamic instability despite pharmacological support.
* Having conditions that impair evaluation techniques or intervention methods.
The Impact and Coping Strategy of COVID-19 Among Taiwan Society and Medical and Nursing Institutes

The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. As such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. These work in guaranteeing quality and performance, and as such, establishing "Digital Platform for Integrated Research of Coronavirus disease 2019 (COVID-19)".


Eligibility Criteria:
Inclusion Criteria:

* 1.\>20 years old. 2. Medical staff and patients from different tiers hospitals in Taiwan. 3.Community residents in Taiwan

Exclusion Criteria:

* 1.\< 20 years old. 2. These cases who had disabilities can't complete our assessments.
Comparison of Routine and Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Stroke Patients

This is ROM trail study. Data collected from Rabbani Hospital Lahore . in this study total two groups included control and experimental and sample size was 48 and 24 persons divided in each groups as well. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Data analyse by ssps V21.0 with a significant level of p valued 0.05. Results were in the favour of experimental group.

This is ROM trail study. Data collected from Physiotherapy department of Rabbani Hospital Lahore . In this study total two groups included control and experimental and sample size was 48 and 24 persons randomly allocated in each groups as well. In control group conventional therapy given while in experimental group core-stability exercises with conventional therapy given to the patients. while the duration of therapy was 45 minutes per day for 8 weeks. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Only having first episode of sub-acute stoke patients and diagnosed by Neuro-physician were included in study. Data entered and analysed by SSPS V21.0 with a significant level of p valued 0.05. and the results were in the favour of study means experimental group.

Eligibility Criteria:
* Inclusion Criteria:

  * Sub-Acute ischemic and stroke diagnosed by neuro-physican having 1st episode
  * Patients in sub-acute stage (2-12 weeks)
  * Patients who can follow the instruction according to mini mental scale \< 7
  * Minimum score of a patient on burg balance and trunk impairment scale to enter in rehab unit and include in any research i-e TIS \< 2 in scoring and BBS \< 4 minimum scoring.
* Exclusion Criteria:

  * Recurrent stroke
  * Subjects with radiating pain or nerve root involvement
  * Diagnosed by any neurological condition other than stroke, or other clinical comorbidity that affect the trunk balance.
  * Patient unable to follow the instructions
  * Comprehension deficits that prevented them from following verbal commands
  * Unconscious patient
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System

The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.

Subject data will be reviewed at the following visits:

* Preoperative
* Operative
* Every 7 to 14 days through Distraction Phase
* Every 4 to 6 weeks through Consolidation Phase
* 6-Month Post-Consolidation
* 12-Month Post-Consolidation
* 18-Month Post-Consolidation
* 24-Month Post-Consolidation

Eligibility Criteria:
Inclusion Criteria:

* Leg length discrepancy ≥ 1.5 cm and ≤ 6.5 cm due to short femur or tibia
* Weight ≤ 114 kg if implanted with the 10.7 mm or 12.5 mm diameter nail, or ≤ 57 kg if implanted with the 8.5 mm diameter nail
* Skeletally mature
* Intramedullary canal without offset
* Tibia or femur sufficient to contain the implant
* Availability, willingness, and sufficient cognitive awareness to comply with protocol procedures and schedule
* Must sign informed consent to permit the use of personal health data

Exclusion Criteria:

* Active infection or previous history of deep infection in the involved bone
* Metal allergies or sensitivities to the components of the device
* Distance from the nearest convenient external surface of the treated limb to the intramedullary canal \> 38 mm for the 8.5 mm PRECICE nail, \> 51 mm for the 10.7 mm PRECICE nail, or \> 76 mm for the 12.5 mm PRECICE nail
* Significant range of motion deficit of the adjacent joints
* Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic or magnetic implant
* Patients who require an MRI during implantation
* Non-union
* Impassable or obstructed intramedullary canal
* Significant angular deformity that prevents device placement
* Cannot bear weight on the contralateral limb
* Procedural osteotomy cannot be made in an appropriate location
* Deformities that require multilevel osteotomies or bi-lateral implantation at the time of study index surgery
* Systemic bone disease
* Pregnant or nursing women
* Inadequate vascularity or evidence of vascular disease or peripheral neuropathy
* Malignancies or tumors in the involved bone
* Patient is a drug abuser
* Open wounds or ulcers that could compromise treatment
Characteristics in Post Covid-19 Patients

To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitation protocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to be conducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging and blood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later (T3). Expected results: a) clinical, image and transcriptome changes; b) clinical-functional improvement after CPRP.


Eligibility Criteria:
Inclusion Criteria:

* With confirmed diagnosis for SARS-COV-2.

Exclusion Criteria:

* With any type of simultaneous pneumopathy.
* Patients with autoimmune disease
* People with simultaneous infectious diseases
* Pregnant women
* With degenerative diseases of the nervous system or musculoskeletal system
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A

Primary objective

• To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection

Secondary objectives

* To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and EHL rFVIII after a single IV injection
* To evaluate the safety and tolerability of a single IV injection of BIVV001

This is a Phase 1, single center, open-label, sequential treatment, 3-period fixed sequence study to assess PK profiles of BIVV001, SHL and EHL rFVIII after a single IV injection in male, previously treated patients, 18-65 years of age, with severe hemophilia A (defined as \<1 IU/dL \[\<1%\] endogenous FVIII).

The expected duration of the study is up to approximately 67 days including

* Screening and washout up to 28 days,
* Advate® dosing, PK sampling, including washout: approximately 4 days,
* Adynovi® dosing and PK sampling, including washout: approximately 7 days,
* BIVV001 dosing and PK sampling: approximately 14 days, Remainder of Safety Observation Period: approximately 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A, defined as \<1 IU/dL (\<1%) endogenous FVIII activity.
* Previous treatment for hemophilia A, defined as at least 150 days documented prior exposure to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 1.
* Platelet count ≥100,000 cells/µL at Screening.
* A participant known to be human immunodeficiency virus (HIV) antibody positive, either previously documented or identified from screening assessments, must have the following results prior to enrollment. (CD4 lymphocyte count \>200 cells/mm³ - Viral load of \<400 copies/mL).

Exclusion Criteria:

* Any concurrent clinically significant liver disease that, in the opinion of the Investigator, would make the participant unsuitable for enrollment. This may include, but is not limited to cirrhosis, portal hypertension, and acute hepatitis.
* Serious active bacterial, fungal or viral infection (other than chronic hepatitis or HIV) present within 30 days of Screening.
* Other known coagulation disorder(s) in addition to hemophilia A.
* History of hypersensitivity or anaphylaxis associated with any FVIII product.
* History of a positive inhibitor test defined as ≥0.6 BU/mL, or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII administrations. Family history of inhibitors will not exclude the participant.
* Positive inhibitor result, defined as ≥0.6 BU/mL at Screening.
* Major surgery within 8 weeks of Screening.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.