cyrilzakka/clinical-trials huggingface dataset:
Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia

Metabolic disorders that can occur during pregnancy, in particular disorders of lipid metabolism and insulin resistance, can have a detrimental effect on pregnancy and the fetus.

The triglyceride level and other lipids increase slightly during pregnancy. This increase has a positive effect on the development of the fetus. However, an excessive increase in lipid levels can cause some metabolic disorders such as gestational diabetes and increase feto-maternal morbidity/mortality.

While some existing studies have shown that elevated triglyceride levels can cause fetal macrosomia, others have found no correlation between these two variables. The ratio of triglycerides to HDL is a widely used marker for lipid disorders. In addition, the triglyceride-glucose index is also an index used to detect insulin resistance.

In this study, the investigators aimed to investigate whether the ratio of triglycerides to high-density lipoprotein cholesterol and the triglyceride glucose index are associated with fetal macrosomia in low-risk nulliparous pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Screening for fetal macrosomia was based on the term defined according to the standards of the American College of Obstetricians and Gynecologists (ACOG).
* Low-risk nulliparous singleton pregnant women.
* Age between 18 and 40 years old

Exclusion Criteria:

* Post-term pregnancies
* Hospitalized for preterm labor or preterm premature rupture of membranes.
* Gestational diabetes mellitus, diabetes mellitus type I - type II.
* Pregnant women with fetal growth restriction, hypertensive pregnancy disorders, familial hypercholesterolemia and hyperlipidemia.
* Multiparous pregnant women
* Multiple pregnancies
* Pregnant women with chronic diseases.
* Pregnant women with impaired liver function;
* Pregnant women with body mass index \<25 and \>40 kg/m2.
The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer

The goal of this study is to evaluate the diagnostic value of different ADC values (incuding ADCmin, ADCmean, ADCratio and ADCrange) of bpMRI in patients with PI-RADS 3-5. The main aim is to evaluate whether different ADC values improve the diagnosis of clinically significant prostate cancer (Gleasonscore≥3+4, ISUP grade ≥2) and any-grade prostate cancer (Gleasonscore≥3+3, ISUP grade ≥1).

The study is conducted with suspected prostate cancer. Patients with PI-RADS scores of 3-5 after completing prostate bpMRI chose to undergo prostate biopsy. Before patients undergo prostate biopsy, researchers will collecte information on age, BMI, tPSA, f/PSA, PV, PSAD, ADCmean, ADCmin, ADCmax, ADCnormal, maximum lesion diameter, location of major lesions, and so on. For prostate biopsy, systematic prostate biopsy ± bpMRI cognitive fusion targeted prostate biopsy will be completed under the conditions permitted by physical condition, and Gleason score will be clearly given by pathologists if the final diagnosis is prostate cancer. In this study, the pathological result is regarded as the gold standard. ROC curve, area under curve, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and other indicators of diagnostic test were calculated. Relevant conclusions are finally drawn by comparing the diagnostic capacity of different ADC values for prostate cancer. Meanwhile, binary logistic regression analysis will also conduct the Odds ratios (ORs) and 95% confidence intervals (CIs) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. The patient met at least one indication of prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) https://rs.yiigle.com/cmaid/1442948 );
2. Serum PSA test was completed in the patient with tPSA \< 100 ng/ml;
3. Primary prostate tumor lesion, no history of other tumors;
4. Completed 3.0T bpMRI examination, PI-RADS score ≥3 score, the image is clear and readable;
5. Patients fully understand the relevant contents of the study and voluntarily sign the informed consent.

Exclusion Criteria:

1. The patient has contraindications for MRI;
2. PI-RADS 1-2 of bpMRI;
3. The patient had contraindications to prostate biopsy or explicitly refused biopsy;
4. bpMRI indicated that the patient had multiple lymph nodes or bone metastases;
5. Previous prostate-related surgery;
6. The patient refused to sign the informed consent.
Hip Manipulation in Basketball Players

Currently, it is difficult to find studies in the literature assessing the impact of manual therapy on preventing lower limb injuries in basketball players, which may later translate into improved strength and balance in athletes, when planning training or therapy programming, e.g. in patients after ankle sprains.


Eligibility Criteria:
Inclusion Criteria:

* healthy persons aged 18,
* first league competitor,
* competitor who regularly competes in the league,
* expressing informed consent to participate in the study and undertakes to comply with track regulations and wear a helmet.

Exclusion Criteria:

* lack of volunteer consent,
* previous surgeries of the upper, lower limb and spine,
* other lower limb injuries in the last 6 months,
* pain limiting participation in the study,
* neurological diseases,
* connective tissue diseases.
Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

The primary objectives of this study are:

* To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx).
* To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant (ASCT) ineligible DLBCL participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies
* DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL) expressing CD 20, relapsed or refractory to at least 2 prior lines treatment containing anti-CD20 therapy
* Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies
* DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment
* Adequate performance status and hematological, liver and kidney functions
* Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Key Exclusion Criteria:

* Active brain metastases
* Prior allogeneic hematopoietic cell transplantation
* Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents
* Second malignancy within the last 3 years
* Known active or chronic hepatitis B or C infection or HIV
* Pregnancy or active breastfeeding
* Prior chimeric antigen receptor (CAR-T) therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
* Have severe or very severe AA, as determined by all of the following:

  * Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline.
  * No spontaneous improvement over the past 6 months.
  * Current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.
* Male or nonpregnant, nonbreastfeeding female participants.

Exclusion Criteria:

* Primarily "diffuse" type of AA.
* Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
* Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
The Chocolate Study 2.0

The purpose of this study is to test how the brain responds when enjoyable foods such as chocolate are consumed. The investigators know that eating certain types of foods can make an individual want to keep eating even when he or she is full. The chemical in the brain that causes this is called dopamine. The investigators can measure this response by looking at changes to how an individual's eye responds to light.

The overall objective of this study is to determine dopamine (DA) neuromodulation (changes in b-wave amplitude as measured by electroretinography (ERG)) in response to consuming a highly reinforcing food (chocolate). The investigators hypothesize that orosensory stimulation with chocolates with increasing sugar content will increase the beta wave (b-wave) amplitude and the increase in the b-wave amplitude will correlate with score changes on the Psychophysical Effects Questionnaire (PEQ). This will be accomplished by testing different chocolates (extreme dark (90% cocoa), dark (70% cocoa), milk (38% cocoa), and white (0% cocoa)) on different days using 1.0 cd∙s/m2 flash luminance energy.

Eligibility Criteria:
Inclusion Criteria:

* BMI 20-24.9 kg/m2
* ability to understand and sign the consent form
* availability of transportation (i.e., participants must be able to provide their own transportation to the Grand Forks Human Nutrition Research Center)
* be free of any major illness/disease

Exclusion Criteria:

* food allergies
* participation in a weight loss diet/exercise program
* pregnancy
* lactation
* metabolic illness/disease (diabetes, renal failure, thyroid illness, hypertension)
* eye illness/disease (narrow angle glaucoma, macular degeneration, retinal detachment, cataracts)
* psychiatric, neurological or eating disorders (schizophrenia, depression, Parkinson's Disease, Huntington's Disease, cerebral palsy, stroke, epilepsy, anorexia nervosa or bulimia nervosa)
* taking any type of prescription medication with the exception of oral contraceptives and antihyperlipidemia agents
A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab

This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in three countries, Australia (3 sites), Canada (2 sites), and Germany (2 sites).

61 participants were randomized, and 60 received at least one dose of the study drug. One participant, who was randomized to the New formulation of adalimumab/Current formulation adalimumab arm of the study, discontinued from the study and never received study drug.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject age 18 years or older, who requires Humira 40 mg SC every other week (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordance with the local Humira label.
* Subject must be a current, on-label user of Humira who rates his/her average Humira injection site related pain as at least 3 cm on a pain Visual Analogue Scale and has had at least 6 consecutive doses of Humira prior to Screening, or a biologic naïve subject who requires initiation of on-label treatment with Humira.
* Subject has diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised ACR classification criteria or the ACR/EULAR 2010 criteria,
* Female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least one method of birth control throughout the study and for at least 70 days after the last dose of study drug.
* All female subjects of childbearing potential must have a negative test for pregnancy on a serum sample at Screening and prior to study drug dosing on a urine sample obtained at Visit 1.

Exclusion Criteria:

* Subject has been treated with any investigational drug of a chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit 1.
* Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Visit 1 or oral anti-infectives within 14 days prior to Visit 1.
* Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
* Known hypersensitivity to adalimumab or its excipients.
* History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects

Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat in the treatment of heart failure in paediatric patients is planned under the paediatric investigational plan (PIP). In order to administer vericiguat to children, a vericiguat paediatric formulation is needed. This paediatric formulation is characterized in this study prior to its use in paediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at informed consent
* Race: white
* Body Mass Index (BMI): above or equal 18.0 and below or equal 29.9 kg / m²

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Febrile illness within 1 week prior to the first study drug administration
* History of postural syncopes
* A history of relevant diseases of vital organs, of the central nervous system or other organs
* A history of relevant smell and / or taste disorders
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.
* Known gastro-intestinal disorders (e.g. stomach ulcers, duodenal ulcers, gastrointestinal bleeding) or inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency

The purpose of this study is to determine the minimum dose of abiraterone acetate needed to decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid replacement for classic 21-hydroxylase deficiency.

This is a non-randomized (patients will not be assigned by chance to study treatments), open-label (patients will know the identity of study treatments), multiple-dose, intra-patient sequential dose-escalation study with a planned enrollment of approximately 10 patients. This study will consist of a screening period and a treatment period. Due to the intra-patient dose escalation, there will be multiple treatment periods consisting of 8 days each. A rest period of at least 7 days will separate each treatment period. Eligible patients will take study-defined replacement doses of hydrocortisone and fludrocortisone. Abiraterone acetate oral suspension will be administered in daily escalating doses from 100 mg to 500 mg. Patients will proceed to the next higher dose level when the majority of the treated patients have a reduction in the androstenedione level. Serial pharmacokinetic (study of what the body does to a drug) and pharmacodynamic (study of the effects of a drug on the body) samples will be collected at each treatment period as detailed in the protocol. All patients who receive at least 1 dose of abiraterone acetate will be analyzed for safety.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women \>=18 years of age.
* Must be receiving a hormonal contraceptive agent containing both estrogen and progesterone.
* Confirmed 21-hydroxylase deficiency by CYP21A2 genotype associated with classic congenital adrenal hyperplasia.
* Demonstrates a \>=1.5 X ULN of morning serum androstenedione concentration while taking study-defined doses of hydrocortisone and fludrocortisone.
* No coexisting medical conditions in the opinion of the investigator that would preclude participation in the study.

Exclusion Criteria:

* Current or history of active or chronic hepatitis, including symptomatic viral hepatitis A, B, or C.
* Any active infection.
* Evidence of active malignancy.
* Serious or uncontrolled co-existent non-malignant disease.
* Receiving systemic glucocorticoids for any reason other than for the treatment of 21-hydroxylase deficiency.
* Any disorders that require treatment with anticonvulsants.
* Patients of child-bearing potential who are not willing to use a method of birth control during the study and for 3 months after the end-of-study.
* Women who are pregnant or breast-feeding.
* Genotypes associated with non-classic congenital adrenal hyperplasia.
Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma

Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with TACE in patients with intermediate-stage unresectable hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. written informed consent signed prior to enrolment.
2. age \> 18 years, both sexes
3. patients with histologically or pathologically confirmed intermediate hepatocellular carcinoma; BCLC stage B or CNLC stage II
4. no previous antitumor therapy
5. Child-Pugh A or B7.
6. with measurable lesions (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria).
7. ECOG PS score: 0 to 1.
8. expected survival of \>12 weeks.
9. Adequate organ function

Exclusion Criteria:

1. BCLC C stage HCC
2. In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (\> CTCAE Version 5.0 adverse events of grade 2).
3. With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT).
4. Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
5. Patients with tumor thrombus reaches or exceeds the portal vein.
6. History of other malignancies.
7. History of allergic reactions to related drugs.
8. History of organ transplantation.
9. Pregnant women, nursing mothers.
10. Patients have other factors that may interfere with patient enrollment and assessment results.
11. Refuse follow-up as required by this study protocol and refuse to sign informed consent.
Utility of Sodium Lactate Infusion During Septic Shock

ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients

ULIS-1 consists in three arms of treatment during the first 24hrs of septic shock treatment.

* normal saline
* sodium lactate 2.5ml/kg in 60min then
* either 0.25 or 0.5ml/kg/h during 24hrs Main criteria is fluid balance at 48hrs

Eligibility Criteria:
Inclusion Criteria:

* Presence of septic shock
* requiring vascular filling within 12 hours after introduction of Noradrenaline. Septic shock is defined as sepsis with persistent hypotension requiring the administration of vasopressors to maintain RTE \> 65mmHg.
* social insurance

Exclusion Criteria:

* pregnancy
* cardiac arrest
* more than 50ml/kg of fluid loading
* chronic renal failure with chronic hemodialysis or the investigators estimate a need for renal replacement therapy in the following 24hrs
* child C or acute liver failure with PT\<40% (unless AVK)
* plasmatic sodium \<120 or \>145mmol/l
* metabolic alkalosis with pH\>7.45
Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor

Medulloblastoma is a rapidly-growing tumor of the cerebellum, this area controls balance, posture and sophisticated motor functions like finer hand movements, speech, and swallowing. It has been reported that those children fall frequently so the purpose of this study is to investigate the effectiveness of balance and coordination training in these Children.

The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited.

There are Two Main objectives:

1. To investigate the effectiveness of Pilates core stability exercises program. 2. To investigate the effectiveness of Humac balance and tilt system.

Secondary Objectives:

1. The effectiveness of coordination training in children with posterior fossa tumors.
2. The comparison between balance and coordination training and which of both trainings has more effect.

This study will take place in a pediatric oncology setting, Children's Cancer Hospital Egypt(CCHE), in outpatient setting. Patients will be evaluated for their balance and coordination at initial presentation, during treatment, and during follow-up after end of treatment at CCHE. Also patients will receive balance and coordination training, before each chemotherapy cycle-maximum one week- given the patient is in good state.

Sixty children with posterior fossa tumors of both sexes will participate in this study. They will be selected from CCHE. They will be randomly assigned into 3 groups of equal number.

Eligibility Criteria:
Inclusion Criteria:

1. Children with posterior fossa tumors during follow up.
2. Children between 5-12 years old.
3. Time elapsed since the start of treatment more than 4 months in order to be in maintenance phase.
4. They can understand verbal command.
5. Children with no visual, auditory or perceptual disorders.
6. Children are already treated surgically.

Exclusion Criteria:

* Children who have one or more of the following criteria will be excluded from the study:

  1. Children with a genetic disorder or mental retardation.
  2. Children with a chronic lung disease.
  3. Sever cardiomyopathy (ejection fraction \<40%, ischemia and angina pectoris at rest).
  4. Children with a neuromuscular disease not related to tumor.