cyrilzakka/clinical-trials huggingface dataset:
Nadroparin for the Initial Treatment of Pulmonary Thromboembolism

Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are available on the evaluation of body weight adjusted LWMH and standard UFH for the initial treatment of PTE in Chinese population. The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of patients with objectively documented PTE.

Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are available on the evaluation of body weight adjusted LWMH and standard UFH for the initial treatment of PTE in Chinese population.

The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of patients with objectively documented PTE.

An open-label, adjudicator-blinded, randomized controlled trial of patients with symptomatic non-massive PTE from 37 major hospitals in China is conducted . Intravenous UFH was administered received an initial bolus dose of 80 IU/kg, followed by a continuous infusion at an initial rate of 18 IU/kg /hour. The dose was subsequently adjusted by activated partial thromboplastin time (APTT) monitoring. LMWH (nadroparin) was administered subcutaneously at a dose of 86 anti-factor Xa IU/kg every 12 hours.

Both treatments were overlapped with at least 3 months of warfarin therapy. Main outcome measures were combined end point of clinical effect, image improvement,Recurrent venous thromboembolism(VTE), major bleeding, and death within 14 days and 3 months of randomization.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age
* Symptomatic non massive PTE confirmed either by a high probability ventilation-perfusion lung scanning (V/Q scan) or by the presence of intraluminal filling defect on spiral computed tomographic pulmonary angiography (CTPA)
* Haemodynamic stabile, anatomic obstruction no more than 2 lobes on CTPA, or defect no more than 7 segments on V/Q scan,and normal right ventricular function
* Symptoms within 15 days
* Written informed consent obtained before randomization.

Exclusion Criteria:

* Unfractioned heparin anticoagulation for more than 36 hours prior enrollment,
* Massive PTE or sub-massive PTE requiring thrombolytic therapy or pulmonary embolectomy; Active bleeding or disorders contraindicating anticoagulant therapy
* Chronic thromboembolism pulmonary hypertension(CTEPH) without evidence of recent episode; Severe hepatic or renal failure
* Allergy to heparin, other components of Tinzaparin or acenocoumarol,
* Pregnant status;a life expectancy of less than 3 months;
* Previous thrombocytopenia induced by heparin
* Thrombocytopenia \< 100000/mm3,
PET Imaging Targeting Granzyme B Predicts Immunotherapy Efficacy in Diffuse Large B-cell Lymphoma

This study aims to investigate the predictive value of PET imaging targeting granzyme B on the outcome of patients with diffuse large B lymphoma receiving immunotherapy.

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy (CAR-T, Glofitamab or iR2 ).

Eligibility Criteria:
Inclusion Criteria:

1. Pathologic diagnosis of DLBCL
2. Patient's general condition is good and survival is expected to be greater than six months
3. Signed and dated informed consent form

Exclusion Criteria:

1. Combined with other malignant tumors
2. Patients with serious medical conditions who, in the opinion of the investigator, are not suitable for participation in this clinical study
3. Pregnant women and women at risk of pregnancy, breastfeeding women
4. poor compliant
Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor

The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned.

Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years with advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and suitable for a treatment with cisplatin

  * Life expectancy more than 3 months
  * ECOG Performance status 0-1
  * Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) may represent a risk for the patient
  * Adequate baseline bone marrow, hepatic and renal function, defined as follows:
  * Neutrophils \> 1.5 x 10\^9/L and platelets \> 100 x 10\^9/L
  * Bilirubin \< 1.5 x ULN
  * AST and/or ALT \< 2.5 x ULN in absence of liver metastasis
  * AST and/or ALT \< 5 x ULN in presence of liver metastasis
  * Serum creatinine \< 1.5 x ULN
  * Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
  * Patients may have had prior therapy providing the following conditions are met:
* Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days
* Corticosteroid therapy wash out period of 14 days
* Surgery: wash-out period of 14 days
* Patients must give written informed consent to participate in the study

Exclusion Criteria:

* Previous signs of severe toxicity platinum related
* Patients must not receive any other investigational agents while on study
* New York Heart Association class III or IV cardiac disease
* Unstable angina
* Patients with myocardial infarction within the last six (6) months
* Patient with significant peripheral vascular disease
* Clinical signs of CNS involvement
* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
* Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Poor Ovarian Responders Undergoing IVF Using Luteal Ovarian Stimulation Versus Follicular Ovarian Stimulation

The investigators attempted to compare the clinical outcomes and cumulus genes expression in poor ovarian responders undergoing luteal ovarian stimulation or follicular ovarian stimulation in in vitro fertilization cycles.

Multiple follicular wave theory proposed by Baerwald et al. implied that follicle recruitment may occur in the luteal phase of menstrual cycle. Therefore, luteal phase ovarian stimulation (LPOS) was considered as a potential feasible stimulation method during in vitro fertilization (IVF) cycle. In the beginning, in order to avoid delaying cancer treatment, LPOS was applied for fertility preservation of cancer patients, showing no difference in numbers of oocyte retrieved, mature oocytes and fertilization rate between luteal or follicular phase stimulation. In the recent, LPOS was used for infertility women, suggesting that LPOS owned quite good IVF outcomes. In previous studies, premature luteinizing hormone (LH) surge, a major reason worsening ovarian quality in poor ovarian responders (PORs), was seldom found in LPOS. High progesterone in luteal phase may aid in suppressing premature LH surge. An updated research claimed that numbers of oocyte retrieved, mature oocytes and fertilized oocytes in LPOS significantly increased when compared to follicular ovarian stimulation. Therefore, the investigators presumed that LPOS was a more effective method than follicular stimulation in PORs.

Eligibility Criteria:
Inclusion Criteria:

* Poor ovarian responders (PORs) met the Bologna criteria, having at least two of the three following features:

  1. advanced maternal age (≥ 40 years) or any other risk factor for POR,
  2. a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and
  3. an abnormal ovarian reserve test. An abnormal ovarian reserve test was defined as antral follicle count (AFC) \< 5 or anti-Müllerian hormone (AMH) \< 1 ng/mL in this study.

Moreover, two episodes of a previous POR after maximal stimulation alone would be sufficient to define a patient as a POR.

Exclusion Criteria:

* oophorectomy
* exposure to cytotoxic or pelvic irradiation for malignancy
* taking herbal drugs or other hormonal agents
Study of SDMB (2,2 Dimethylbutyrate, Sodium Salt) in Beta Thalassemia Intermedia in Thailand

Beta thalassemia intermedia is an inherited blood disease caused by molecular mutations which reduce the beta globin protein chain of adult hemoglobin A, the protein in red blood cells which carries oxygen throughout the body. Beta thalassemias cause progressively severe anemia, widespread organ damage, and often require blood transfusions. There is no FDA approved therapeutic to treat the underlying cause of beta thalassemia. Fetal hemoglobin is another type of endogenous hemoglobin which can replace the reduced beta globin protein, reduce the anemia, and even abolish transfusion requirements. This type of hemoglobin is normally suppressed in infancy.

Sodium 2,2 dimethylbutyrate (ST20, or HQK-1001) is a small molecule which stimulates production of fetal hemoglobin in nonhuman primates and in human patients in Phase I/II trials.

This is a Phase 2 open-label trial to evaluate the ability of this oral therapeutic to reduce anemia in patients with beta thalassemia intermedia, when administered once daily for 26 weeks. All participants will receive the study drug.

This trial will:

1. Determine the proportion of patients in which treatment with the study drug results in an increase in total hemoglobin by 1.5 g/dl above baseline levels when administered for 26 weeks in Thai patients with beta thalassemia intermedia, including Hemoglobin E beta thalassemia.
2. Determine the number and proportion of participants in whom treatment with the study drug results in an increase in fetal hemoglobin.
3. Determine the number of participants who have adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Beta Thalassemia Intermedia
* Splenectomized
* Average of two Hgb levels between 6.0 and 9.0 g/dl

Exclusion Criteria:

* Red blood cell transfusion within 3 months of study drug initiation
* Enlarged spleen
* Use of hydroxyurea within 6 months
* QT Segment corrected (QTc)\> 450 msec (men) or 470 msec (women) on screening ECG
* Use of iron chelating agents within 7 days of first dose
* Alanine Transaminase(ALT)\> 4 times the upper limit of normal
* Use of erythropoiesis stimulating agents (ESAs) within 90 days of first dose
* serum creatinine \> 1.5 mg/dL
A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance

This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 - 55
* BMI less than 35
* Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne
* Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
* Self-reported concerns with hormonal skin issues
* Has access to a tape measure for waist measurement
* Generally healthy - don't live with any uncontrolled chronic disease

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* Anyone with known severe allergic reactions
* Anyone who is pregnant or breastfeeding
* Unwilling to follow the study protocol
Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients

The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm


Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral naïve
* HIV RNA \<100,000 copies/mL
* CD4 cell count \>100 cells/mL at screening
* with Karnofsky Score \> 70
* If female,

  * non-pregnant and
  * not breastfeeding
* No AIDS opportunistic infection within 30 days of screening

Exclusion Criteria:

* Subject with an HIV primo-infection status
* Recent history of drug and/or alcohol abuse
* History of psychiatric illness
* If presence of the following mutations :

  * in the protease : one among 32,47,48,50,82,84,90
  * OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71
  * in the reverse transcriptase : 215 or 184.
* If abnormal laboratory results such as :

  * Hb\<8 g/dl
  * Absolute neutrophil count\<750 cells/µl
  * Platelet count\<50 000/ml
Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy

The purpose of this study is to determine the effectiveness of eccentric exercise combined with vibration or cryotherapy in Achilles tendon pathology.

The investigators hypothesis is that the combined eccentric exercise is better than the results presented by the exclusive eccentric exercise.

This intervention differs from the classic studies in that we maintain the intensity throughout the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Sports people
* Positive initial ultrasound diagnosis
* Presence of degenerative changes at achilles mid portion
* Chronic Achilles tendon pain, (3/10 VAS)
* Pain when walking or running of Achilles tendon, (3/10 VAS)
* Pain in load in plantar flexion of Achilles tendon, 3/10 VAS)
* Pain in palpation of Achilles, (3/10 VAS)
* Morning Stiffness

Inclusion Criteria Healthy pople:

* Sports people
* Negative initial ultrasound diagnosis
* No syntomp of achilles tendinophaty

Exclusion Criteria:

* Receive physical, orthotic or physiotherapeutic treatment
* Asociated low back pain, ankle/knee/hip injury that may affect the study
* Previous injury or surgery of Achilles tendon.
* Pathologies that may limit the joint of ankle
* Pregnancy
* Obesity
* Patients with diabetes and/or other endocrine or metabolic pathologies or neurologic pathologies
* Patients diagnosed with cardiovascular disease
* Subjets diagnosed with familiar hypercholesterolemia and/or presence of xanthomas or with hyperuricemia
* Patients who have received renal transplantation
* Subjects who have suffered retinal detachment
* Subjects who have received oral contraceptives, statins, corticoids or hormone replacement therapy in the last six months
* Subjects who have received treatment wiht fluoroquinolones in the last two years
* Subjects who have received treatment with AINE's in the last four weeks
Preoperative Versus Postoperative Quadratous Lunborum Block in Nephrectomy

A multimodal analgesia regimen is suggested after nephrectomy, although some patients still report agonising pain. Regional anesthesia approaches may improve postoperative pain management and reduce the requirement for opioids after renal surgery.QLB provides early and rapid pain relief

In the immediate postoperative period, nerve blocks are considered a type of multimodal analgesia and have recently been proposed as analgesic options for patients undergoing open nephrectomy .

Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. The main barrier to early postoperative ambulation is postoperative pain, which also lengthens hospital stays and raises the risk of respiratory problems and venous thromboembolism. Therefore, strict perioperative pain management can have both immediate and long-term advantages .

QLB provides early and rapid pain relief and allows early ambulation in certain patient populations. Multiple case studies also confirmed the QLB to be a rescue block after different surgical procedures. Complications associated with the performance of abdominal wall blocks are fortunately very rare. However, studies on the effect of anterior QLB on postoperative opioid consumption are scarce .

Regional anesthesia is quickly moving toward using ultrasound guidance as the gold standard. The use of ultrasound has significant advantages over traditional treatments such as nerve stimulation and loss of resistance. The improved safety and efficacy that ultrasound brings to regional anaesthesia will help promote its use and realise the benefits that regional anaesthesia has over general anaesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decreased postoperative complications and an improved postoperative course .

The aim of the present study is to compare the effectiveness of ultrasound-guided preoperative to postoperative QLB on the postoperative pain scores after Radical nephrectomy.

Eligibility Criteria:
Inclusion Criteria:

* o Patients aged between 18 - 60 years old.

  * Both sexes.
  * Physical Status: ASA I and II.

Exclusion Criteria:

* o Refusal of procedure or participation in the study .

  * Physical status: ASA III or above .
  * Infection at site of injection.
  * Psychiatric illness .
  * CNS Diseases like epilepsy, stroke ...etc.
  * History or evidence of coagulopathy .
  * Allergies to drug used (Bupivacaine 0.5%).
  * Patients who suffered from allergy to local anesthetics .
  * Difficult visualization of the anatomy.
A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)

This study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or COPD.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent
* General good health
* Asthma or COPD
* Capable of understanding the requirements, risks, and benefits of study participation.
* Able to demonstrate proper metered-dose inhaler use and technique.
* Other inclusion criteria apply

Exclusion Criteria:

* History of life-threatening asthma or COPD that is defined for this protocol as an asthma or COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of Screening Visit.
* Is being treated with a long-acting β2-agonist alone.
* Is currently being treated with Ventolin HFA.
* Any asthma or COPD exacerbation requiring oral corticosteroids within 2 months of Screening Visit. A subject must not have had any hospitalization for asthma or COPD within 4 months prior to Screening Visit.
* Historical or current evidence of a clinically significant non-asthmatic acute or chronic condition.
* Uncontrolled hypertension
* History of any adverse reaction to any component of the HFA-MDI formulation.
* Participation in any investigational drug study within the 30 days preceding the Screening Visit.
* Other exclusion criteria apply.
A Cluster Randomized Controlled Trial to Compare the Rate of Antibiotic Infusion

Acute upper respiratory tract infection, commonly known as upper respiratory infection, is an acute inflammation primarily affecting the nose, pharynx, or larynx caused by various viruses and/or bacteria. Viruses are more common, accounting for 70% to 80% of cases, while bacterial infections account for 20% to 30%. For a long time, the high rate of intravenous infusion use has been a prominent issue in clinical diagnosis and treatment in China. The irrational and excessive use of antimicrobials in emergency patients with upper respiratory tract bacterial infections has also become increasingly apparent, imposing unnecessary financial burdens and risks of drug side effects on patients. Therefore, reducing the rate of intravenous antimicrobial administration in emergency patients with upper respiratory tract bacterial infections has become an urgent problem to be solved. By implementing measures such as health education by clinical pharmacists and enhancing the awareness of rational antimicrobial use in doctors, it is expected to lower the rate of intravenous antimicrobial administration, reduce the occurrence of drug resistance, improve treatment convenience for patients, and lower treatment costs while ensuring therapeutic efficacy.

The purpose of this study was to investigate whether clinical pharmacists can reduce the intravenous infusion rate of antimicrobials in emergency patients with upper respiratory tract bacterial infections through medication education for emergency medical staff and to observe whether this intervention will affect the prognosis and medication safety of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with upper respiratory tract infections seeking emergency medical attention;

  * Patients with laboratory tests indicating White Blood Cell (WBC) \>10×10\^9/L or White Blood Cell (CRP) ≥ 10.0mg/L, requiring the use of antimicrobial agents;

    * Patients aged ≥ 18 years; ④ Patients with at least one of the following local signs and symptoms: (1) fever, (2) cough, (3) rhinitis (sneezing, nasal congestion, or rhinorrhea), (4) pharyngitis (sore throat), (5) shortness of breath, (6) wheezing, (7) chest pain, (8) abnormal auscultation findings.

Exclusion Criteria:

* Patients with other infections in addition to upper respiratory tract infections; ② Patients who require hospitalization or treatment in a higher-level medical institution as assessed by medical professionals;

  * Patients who cannot take oral medications or have severe gastrointestinal dysfunction; ④ Special patients, including those with neutropenia, bone marrow suppression, during radiochemotherapy, undergoing immunosuppressive therapy, human immunodeficiency virus (HIV)-positive patients, patients with congenital immune deficiency, pregnant patients, and patients with mental illnesses.