cyrilzakka/clinical-trials huggingface dataset:
Effects on the Patellar Tendon After Low-load Blood Flow Restriction Training.

The main objective of this research project is to study the transient adaptations that occur in the tendon immediately after the object of training with low loads and blood flow restriction and to compare these adaptations with those derived from training with high loads, in order to thus helping to elucidate the complex existing framework regarding the effects of this training methodology on the tendon.

Introduction: Nowadays, it is known that mechanical loading is essential to achieve tendon adaptations. So,if tendons are stimulated in the right way, positive changes will take part on the tendinous tissues increasing its capability to stand mechanical loading.In the last decade, low load blood flow restriction training has developed as an alternative methodto high load training, as some investigations have found a similar increase in force and hypertrophy between both training methods. Although, the evidence about tendon adaptations leading from low load blood flow restriction training is still very limited.Aim: The present study aims to study tendon temporary responses leading immediately after a low load blood flow restriction training and compare those adaptations with those leading from high load strength training.Design: A randomized case-control clinical trial will be conducted.Sample: The measurement of the sample size was done with theG\*Power 3.1.5 program and was based on the time-by-group interaction of a mixed variance analysis (ANOVA). With two groups and three measurement moments. The final sample size was constituted by 84 subjectsMethods:The 84 participants will be randomly allocated in two groups: a) Low load blood flow restriction training (n=42); b) high load strength training (n=42). The low load blood flow restriction training group will perform a strength training with an intensity equivalent to 30% 1RM with an occlusion pressure of 80% on the total restriction pressure assessed individually, whilst the other group will train with a load equivalent of 80% 1RM. Patellar tendon characteristics will be studied as morphometry and densitometry parameters and microcirculation pre, post immediate intervention and 24 hourspost intervention.

Eligibility Criteria:
Inclusion Criteria:

* Physically active population (physical activity between 1 and 3 weekly sessions). With the final purpose to adjust the results to normality and refer to a general population.
* Subjects who have received the information sheet and have given their consent informed to participate in the study.

Exclusion Criteria:

* People who reproduce pain or symptomatology to the execution of the exercise of the treatment.
* People who have had symptoms in the last 2 months in the region below patellar
* Present musculoskeletal injuries or inability to perform the protocol experimental.
* Individuals with a training frequency equal to or greater than 5 sessions per week or that present a RM equal to or greater than 110kg. Since they do not fit a population and may affect the homogeneity of the sample.
Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women

In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women.

Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.

Many HIV-infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV-infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants.

No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.

Eligibility Criteria:
Inclusion Criteria:

* Infant born to HIV-1 infected mother enrolled in NIH-sponsored, international antiretroviral treatment trial AND who has had either in utero or postpartum antiretroviral exposure
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure
A Clinical Study on the Prevention of Mild to Moderate Intermittent Asthma With Chinese Medicine Weiyang Yuping Fang

Clinical exploring study of Weiyang Yuping Decoction in preventing acute attacks of mild to moderate intermittent asthma Based on the theory of "Preventing disease from exacerbating" in Chinese medicine.

Based on the preliminary clinical and basic research, this project intends to highly optimize and integrate the TCM treatment of disease theory with the current methods to form two preventive treatment plans, one treatment group was given Weiyang Yupingfang Granules orally for 1 month on the "Sanfu"days and on the "Sanjiu" days each year for a total of 2 months one year; the other treatment group was given Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months one year.; Comparing the effect of prevention and treatment of mild to moderate intermittent asthma exacerbations of the two prevention methods , provides new ideas for the prevention and treatment of bronchial asthma in the future, and further improves bronchial The level of prevention and treatment of asthma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma according to GINA criteria with a documented history of at least 3 years prior to Visit 1
* Patients have asthma exacerbations every year
* Meet the diagnostic criteria for mild to moderate asthma
* Able to measure lung ventilation function according to ATS (American Thoracic Society) standards
* Patients who have given written informed consent

Exclusion Criteria:

* Medical history of life-threatening asthma including intubation and intensive care unit admission
* Any significant disease or disorder (e.g., cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
* Pregnancy, breast-feeding or planned pregnancy during the study.
* Participation in another clinical study or took other research drugs during the last 30 days prior to Visit 1
* Known or suspected hypersensitivity to study drugs or excipient
* Suspected poor capability, as judged by the investigator, of following instructions of the study.
FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort

The Stanislas Cohort is a monocentric familial longitudinal cohort originally comprised of 1006 families consisting of two parents and at least two biological children and deemed healthy, recruited in 1993-1995 at the Centre for Preventive Medicine of Nancy. This cohort was established with the primary objective of investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases. The 5th visit of the STANISLAS Cohort will allow a better evaluation of the cardiovascular ageing of the population and the transition toward cardiovascular or renal diseases in relation with their genetic profile and environment.

The main objective of the STANISLAS cohort is to identify the factors associated with cardiovascular aging (assessed through the study of the degradation of morphological and functional parameters of the heart and vascular systems).

Data (clinical, biological, morphological, genetic and lifestyle) from previous visits (the first having been initiated in the mid-1990s) will be considered as exposure and / or adjustment variables.

The exposure variables of interest will be:

* The components of metabolic syndrome (MS),
* Genetic determinants, through an approach of family segregation and candidate genes,
* Multi-omic biomarkers analyzed from the biological collection of the first assessments of the cohort
* Food intake, nutrition and eating behavior

The secondary objectives are

* Identify the factors associated with a degradation of renal parameters (renal function and proteinuria).
* Identify the factors associated with a degradation of metabolic parameters.
* To assess the association between SARS-CoV-2 infection (questionnaire and serological approach) and cardiovascular and renal parameters
* Identify factors associated with the occurrence of clinical cardiovascular events.
* Association between Covid 19 events and general disabling symptoms
* Complete the cohort's biological collection for future biomarker assays related to previous objectives

Eligibility Criteria:
Inclusion Criteria:

* aged over 18
* Person who participated in the Stanislas Cohort
* Person affiliated to a social security scheme or beneficiary of such a scheme
* Person having received complete information on the organization of the research and having signed an informed consent

Exclusion Criteria:

* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code:

  * Pregnant woman, parturient or nursing mother
  * Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
  * Person of full age unable to express consent
Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH

A randomized, multi-center study evaluating MET409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. Assignment to MET409 will be double-blind and placebo-controlled. Empagliflozin will be incorporated into two of the treatment arms in an open-label manner.

Subjects assigned to receive empagliflozin will be dosed at 10 mg per day for the duration of the study.

Approximately 30 subjects will be enrolled per treatment arm.

Eligibility Criteria:
Key Inclusion Criteria:

* Males and females 18 through 75 years of age.
* Diagnosis of NASH based on NAFLD Activity Score (NAS) ≥ 4 with at least 1 point in each of steatosis, inflammation, and ballooning; Magnetic Resonance Elastography (MRE) showing kPa ≥ 2.61 or a multiparametric MRI (ie, LiverMultiScan) showing iron-corrected T1(cT1) \> 830 ms within 6 months of enrollment; or Transient elastography (TE, FibroScan) with liver stiffness ≥ 8.5 kPa and controlled attenuation parameter (CAP) \> 300 dB/m obtained within 3 months of enrollment.
* Liver fat content ≥ 8% measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during screening.
* Diagnosis of T2DM for ≤ 10 years, with hemoglobin A1c ≤ 10.0% during screening, stable and controlled with diet or treatment for at least 3 months.

Key Exclusion Criteria:

* History of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant.
* Presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis).
* Excessive consumption of alcohol.
* Use of any insulin (injectable or inhaled), SGLT-2 inhibitor or glucagon-like peptide 1 (GLP-1, injectable or oral) products for \> 7 days within 3 months of screening.
* Weight loss \> 10% in the 6 months prior to screening or \> 5% during screening.
* Use of drugs historically associated with causing NAFLD for more than 4 consecutive weeks within 12 months prior to screening.
* Concomitant use of drugs that are strong or moderate CYP3A4 inhibitors.
* Concomitant consumption of grapefruit juice with the study drug.
* History of diabetic ketoacidosis (DKA) within 1 month prior to the Screening Visit, or more than 2 episodes within 6 months prior to the Screening Visit.
* History of \> 2 episodes of urosepsis or pyelonephritis within 5 years of screening.
Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.

The goal of this prospective observational study is to examine the potential association between intra-abdominal pressure and venous congestion as assessed by abdominal ultrasound, in critically ill patients in the Intensive Care Unit (ICU).

The main question it aims to answer is whether there is association between intra-abdominal pressure and Venous Excess Ultrasound (VExUS) score.

Participants will be sonographically assessed and their intra-abdominal pressure measured once within the first 3 days of ICU admission.


Eligibility Criteria:
Inclusion Criteria:

* Intubated ICU patients on controlled mechanical ventilation, receiving sedation. Patients must have urethral catheter in place.

Exclusion Criteria:

* age \< 18 year old
* pregnancy / lactation
* primary liver disease (hepatic cirrhosis, hepatic space-occupying lesions, Budd-Chiari syndrome, portal vein thrombosis) or hepatic surgery
* end stage renal failure or on chronic dialysis
* non-intubated patients or intubated patients on non-controlled mechanical ventilation mode
* absence of urethral catheter, presence of suprapubic catheter, continuous bladder irrigation
* poor abdominal echogenicity
Effectiveness of Periodontal Therapy on Periodontal Bacteria

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of Periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth scaling or quadrant scaling

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Serotonin has recently been identified as a major regulator of bone formation. Gut-derived serotonin inhibits bone formation, and early animal studies have shown that inhibition of gut-derived serotonin has anabolic effects on bone in ovariectomised rodents. This pathway has potential to be developed as a new anabolic treatment for osteoporosis in humans.

Carcinoid neuro-endocrine tumours produce very high levels of serotonin, and so it might be expected that patients with carcinoid disease would have reduced bone formation, low bone mass and fractures. However, this has not been apparent in clinical practice. There may be a discrepancy between rodent models and human disease. This study aims to identify whether patients with carcinoid disease have reduced bone mass, reduced bone formation or high fracture rates. The investigators will conduct a cross-sectional observational case-control study of patients with carcinoid disease in the Sheffield neuro-endocrine tumour clinic and gender-, age- and body mass index (BMI)-matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Able to give informed consent
* Patient with carcinoid syndrome-active disease (untreated or receiving medical treatment)
* or
* Healthy volunteer who adequately matches a patient with carcinoid syndrome gender, age (±5 years), height (±5cm) and BMI(±3 kg/m2)

Exclusion Criteria:

* Curative surgery for carcinoid disease
* Body weight over 159 kg (weight limit for DXA measurement of BMD)
* Previous orthopaedic surgery or fractures which preclude imaging at all sites
* History of any long term immobilization (duration greater than three months)
* Fracture less than one year prior to recruitment
* Current pregnancy or trying to conceive
* Delivery of last child less than one year prior to recruitment
* Breast feeding less than one year prior to recruitment
* History of, or current conditions known to affect bone metabolism

  * Diagnosed skeletal disease or inflammatory arthritis
  * Chronic renal disease
  * Malabsorption syndromes
  * Other diagnosed endocrine disorders
  * Hypocalcemia or hypercalcemia
  * Diagnosed restrictive eating disorder
  * Diabetes mellitus
* Conditions or surgery which prevent the acquisition or analysis of DXA, VFA or HR-pQCT
* Use of medications or treatment known to affect bone metabolism
* Alcohol intake greater than 21 units per week
Vitamin D Supplementation and WBV in Inflammatory Markers, Strength and Body Composition in Old Patients With COPD

Verify the influence off vitamin D supplementation and a whole body vibration (WBV) protocol during 03 months in older patients chronic obstructive pulmonary disease


Eligibility Criteria:
Inclusion Criteria:

* Older patients with COPD
* Both genders
* Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
* BMI in between 22.9 and 28 kg/m2.
* Older patients with COPD should have a clinical-functional diagnosis of the disease according to GOLD (GOLD, 2018), have been ex-smokers and have not used corticosteroids or have used this drug in a stable way for at least one year (without dosage or medication modifications).
* Older volunteers should be self-referenced healthy or, if they had systemic arterial hypertension or diabetes mellitus, these comorbidities should be controlled by diet or regular medication use.

Exclusion Criteria:

* Older patients with COPD who had episodes of exacerbation in the last three months, those with pulmonary rehabilitation programs in the last year, those who used home oxygen therapy, and patients with COPD associated comorbidities were excluded.
* Volunteers of both groups who were taking vitamin D were excluded, as well as the current smokers, although occasional, volunteers with a history of labyrinthitis or thromboembolism, who had undergone surgical procedures of any size in the last year, such as plaques, pins or cardiac pacemakers, those with unconsolidated fractures that used medications that affected bone metabolism or lean mass, or those who had difficulties adapting to the assessment or the training protocol.
Efficacy and Safety of Bortezomib as First-line Treatment of Acquired TTP

To evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired TTP，we design this prospective, multi-center, single-arm interventional study.All enrolled TTP patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2L/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). Bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is\> 24h. Plasma exchange continued until the patient's platelet count was \>100×109/L for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped.

To evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired TTP，we design this prospective, multi-center, single-arm interventional study.All enrolled TTP patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2L/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). Bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is\> 24h. Plasma exchange continued until the patient's platelet count was \>100×109/L for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed as TTP (thrombocytopenia + MAHA± clinical evidence of related organ damage， a significant reduction in ADAMTS13 activity level and/or positive antibody screening）
* elder than 18 years old;
* informed consent is required;

Exclusion Criteria:

* Uncontrollable systemic infection;
* Known allergy to bortezomib;
* Expected survival time \<1 week;
* Pregnant or lactating women (women of childbearing age have a positive pregnancy test at baseline or have not received a pregnancy test. Postmenopausal women must be at least 12 months after menopause);
* If the creatinine level is ≥200μmol/l (1.5mg/dl), the levels of transaminase and bilirubin are 2 times higher than the upper limit of normal (except due to the primary disease);
* Known congenital TTP or a clear family history of TTP;
* Other diseases that cause microangiopathic hemolysis and thrombocytopenia, such as DIC, APS, HUS, malignant hypertension, transplantation-related microangiopathy;
* active malignant tumors (except skin basal cell carcinoma or cervical carcinoma in situ) ( have not been treated or recurred within 5 years before signing the informed consent);
* peripheral neuropathy;
* Patients or family members cannot understand the conditions and goals of this study;
* The investigator believes that the patient should not participate in any other situations in this trial.