cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults

A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults


Eligibility Criteria:
Inclusion Criteria:

* BMI≥28 but \< 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but \< 28 kg/m2 with any of the following:

  1. Hypertension
  2. Dyslipidemia
  3. Obstructive sleep apnea syndrome
  4. MASH
  5. Pain in the weight-bearing joints
* At least one previous failure to lose weight through lifestyle modification was defined as \< 5% weight loss after ≥3 months of lifestyle modification

Exclusion Criteria:

* Weight change ≥5% as reported or documented.
* Previous diagnosis of type 1, type 2, or any other type of diabetes.
* Diagnosis of overweight or obesity due to other diseases or medications.
* History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
* Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
* GLP-1R agonist use within 6 months prior to signing ICF.
* Use of hypoglycemic drugs within 3 months before signing ICF.
Intraoperative Noradrenaline to Control Arterial Pressure (INPRESS Study)

The purpose of this study is to evaluate whether a preventive strategy of intraoperative arterial hypotension using noradrenaline can reduce the incidence of postoperative organ failure.

The maintenance of arterial blood pressure is essential for organ perfusion pressure. Intraoperative hypotension is a frequent complication both after induction and during maintenance of anaesthesia, ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to the occurrence of a systemic inflammatory response syndrome and is a key determinant of postoperative complications. Persistent intraoperative hypotension has been reported as an important prognostic factor of postoperative morbidity and mortality. Adequate treatment of arterial hypotension is therefore of particular importance during surgery, but optimal strategy of intraoperative blood pressure management remains undetermined, especially in high-risk patients. Target ranges for arterial pressure are not clearly defined, and hypotension is usually defined as a systolic pressure of less than 80 mmHg or a decrease of more than 40% from baseline.

Traditionally, management of intraoperative hypotension consisted primarily of fluid administration whereas vasoconstrictors, such as Ephedrine chlorhydrate, are often used as a second line therapy. This may, however, expose patients to prolonged hypotension and to excessive fluid administration, and each of them may alter tissue oxygenation.

Recent experimental data have shown that noradrenaline, which has - and -adrenergic effects, has no detrimental effects on microcirculatory blood flow and tissue oxygenation in the intestinal tract. Because of anaesthesia-induced vasodilatation, the use of a continuous infusion of noradrenaline to increase systemic vascular resistance could be useful to prevent detrimental effects of compromised tissue perfusion, especially in high-risk surgical patients.

The primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate.

The investigators hypothesis is that maintenance of arterial blood pressure with noradrenaline could reduce postoperative organ dysfunction in high-risk surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* ASA score ≥ 2
* Planned and unplanned surgical procedures
* Abdominal, orthopaedic and vascular surgery
* Expected duration ≥ 2 hours
* AKI risk index ≥ class 3

Exclusion Criteria:

* Severe preoperative hypertension (not controlled)
* Creatinine clearance \< 30 ml/min or preoperative dialysis
* Acute cardiac failure
* Preoperative sepsis
* Preoperative hemodynamic failure (shock)
* Intraoperative use of locoregional anaesthesia (epidural and spinal)
* Patient refusal
* Pregnancy and/or lactation
Comparative Effects Of Mud Based Plyometric Jump Training on Volleyball Players

Volleyball is a high-intensity, anaerobic sport that alternates between brief rest intervals and explosive movements in both vertical and horizontal planes. Therefore, it is believed that essential components of successful athletic performance are explosive strength, speed and power which are defined as the neuro- muscular system of an individual's ability to manifests training the shortest amount of time. The complex movement of a vertical jump necessitates the coordination of multiple muscles in the arms, legs, and trunk. Being aware that a five-set volleyball match requires more than 250 jumps from each player. Eight weeks of plyometric jump training on mud and other unstable surfaces caused some changes in the biomechanical variables and physical fitness related to volley ball performance in volley ball players. Thus, by adding more high-intensity training, elite volleyball players can maximize their physical performance level during the competitive season.

This study was randomized clinical trial and was conducted in Pakistan Sports Board in duration of 10 months. Non-probability convenient sampling technique was used. Sample size was 30 calculated by G-power using 50-m sprint as variable. Participants were recruited into 2 equal groups by the process of randomization according to inclusion and exclusion criteria. One group performed mud based plyometric jump training with high intensity interval training which included alternate jump lunge, split squat jump and pop squat jump 4 repetitions, 3 sets and other performed mud based plyometric jump training without high intensity interval training which included plate pogo and broad jump 4 REPS, 3 SETS. Data was analyzed by SPSS version 25.

Eligibility Criteria:
Inclusion Criteria:

* Age:17-35years
* Male Volleyball players
* 1 Repetition Maximum (RM) of 10kg
* BMI in the range of 18.5 to 24.9
* Players had game experience of at least 2years

Exclusion Criteria:

* Musculoskeletal issues(Jumper's knee, Foot and ankle injuries, Patellar tendinopathy, Ligamentous and meniscal injury, Bone deformity, Fractures of lower limb)
* Cardiac and Pulmonary disorder
* Vestibular and visual disorder
Safety and Efficacy of Herbmed Plus in Patients withRenal Calculi

More specifically, the present invention relates to a 'Herbal Preparation' that is useful for

* Treatment of Renal calculi
* Reduction in the stone size \& surface area
* The expulsion of stone
* Decreased need of Analgesic(Antiinflammatory Effect)
* Stops the recurrence and reformation of renal

1. Study duration 28 weeks
2. No. of Scheduled visits 8 visits
3. Study product Dose, Group one-:1capsule (of 500 mg) orally twice a day with meals for 24 weeks. Group two-:placebo1capsule (of 500 mg) orally twice a day with meals for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-75 years (Both inclusive)
* Patients with Renal calculi, diagnosis confirmed by plain X-ray KUB \&/or ultrasound KUB/CT scan Abdomen
* Size of the calculi ranging from 04 mm -09 mm
* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Patients of reproductive potential (males and females) and willing to use a reliable means of contraception (e.g hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation
* Patients will to cooperate \& give consent for the trial\& comes for regular follow up.

Exclusion Criteria:

* Patients having acute condition of renal calculi.
* Any systemic disease requiring other medications of surgery for calculus condition.
* Complicated cases of Renal Calculi requiring surgical condition.
* Chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction
* Any other urogenital disorders.
* Liver dysfunction, defined as total bilirubin more then 1.5 the upper limit of Normal, aspartate aminotransferase more then 2.5 upper limit of Normal, or alanine aminotransferase more then 2.5 upper limit of Normal,
* Kidney disease, including serum creatinine level more then 1.5 upper limit of Normal,
* Subjects on herbal supplements for stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
* Participated in another clinical drug trial within 3 months before recruitment.
* Pregnancy or breast feeding
* Evidence of significant uncontrolled concomitant disease which in the Investigator's opinion would preclude patient participation
* Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline
* Patients with psychiatric illness or other condition that would limit compliance with study requirements
* Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication
* Subjects who refuse to sign the informed consent document .
Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms

This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.

A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).

This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
* Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Currently an inpatient at Stanford Hospital
* Meet the threshold on the total HAMD17 score of \>/=20 at screening/baseline.
* Qualifies and has access to outpatient rTMS treatment

Exclusion Criteria:

* Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
* Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
* History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
* Shrapnel or any ferromagnetic item in the head
* Pregnancy
* Autism Spectrum disorder
* Active substance use (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
* Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
* Cognitive impairment (including dementia)
* Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
* Current mania
* Current unmanageable psychosis
* IQ \<70
* Showing symptoms of withdrawal from alcohol or benzodiazepines
* Parkinsonism or other movement d/o determined by PI to interfere with treatment
* More subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas.
* Any other indication the PI feels would comprise data.
Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm

Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing primary elective total hip replacement

Exclusion Criteria:

* Patients unable to consent to trial
* Active deep and superficial vein thrombosis
* Coagulopathy in initial coagulation screen tests
* Platelet count below 100 thousand
* Patients on antithrombotic medications (except prophylactic low molecular weight heparins and acetylsalicylic acid up to 75 mg per day)
* Preoperative haemoglobin \< 10 g/dl
* Female patients who are pregnant or nursing
Extended Spectrum Beta Lactamase Producing Organisms In Urinary Tract Infections

Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria.

Urinary tract infection is among the most common nosocomial and community acquired infections. The Information on prevailing levels of antimicrobial resistance among common pathogens that associated with urinary tract infection is useful in making an appropriate choice of empiric therapy .

Resistance to antibiotic treatment in patients with urinary tract infections (UTIs) is a representative example of the increasing problem of antimicrobial resistance. Extended-spectrum β-lactamases (ESBLs) has emerged as an important mechanism of resistance in Gram-negative bacteria.

Bacterial production of extended-spectrum β-lactamases (ESBL) significantly reduces the efficacy of the most commonly used beta-lactam antibiotics for the empiric therapy of infections caused by putative Gram-negative .

Extended Spectrum Beta-Lactamase (ESBL) is derived from the mutated beta-lactamase enzyme, Beta-lactamase is an enzyme produced by bacteria that acts to inactivate beta-lactam class of antibiotics .

Extended Spectrum Beta-Lactamase is most commonly produced by the Enterobacteriaceae group, especially Escherichia coli and Klebsiella pneumonia.

ESBL-producing bacteria can also be resistant to the antibiotics class of aminoglycoside, fluoroquinolone, tetracycline, chloramphenicol, and sulfamethoxazole-trimethoprim.

The presence of ESBL-producing bacteria in an infection can result in treatment failure. Antibiotic resistance causes a decrease in the effectiveness of treatment, increases transmission of infection, increases mortality, and increases the cost of health care, while the discovery of new antibiotics is getting less and less

Eligibility Criteria:
Inclusion Criteria:

* This study will be conducted on a group of patients who are diagnosed that have urinary tract infections

Exclusion Criteria:

* The cases that do not give bacterial growth .
H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions

Intervention for coronary bifurcation lesion is about 10\~20% of entire percutaneous coronary intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore, occlusion of side branch frequently occurred during PCI. Several techniques to prevent occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side branch stent is developed to treat coronary side branch lesion and composed of proximal, connecting and distal parts. In vivo study performed in pigs showed effective H-side branch stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of coronary side branch lesion.


Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old
* Patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion
* Bifurcation lesion with 2.5\~4.0mm of main vessel diameter, \<30mm of main vessel length and ≥2.0mm of branched vessel diameter

Exclusion Criteria:

* Acute myocardial infarction
* Confirmed or suspicious presence of thrombus in target lesion
* In-stent restenosis lesion
* Visual angulation with ≥75°
* Lesion with severe calcification or severe tortuosity
* Left main lesion
* Chronic total occlusion lesion
* Graft lesion
* Contraindication to antiplatelet drugs
* Left ventricular dysfunction (LVEF ≤40%)
* Severe hepatic dysfunction (≥2.5 times than reference of AST or ALT)
* Renal dysfunction (serum Creatinine \> 2.0mg/dL)
* History of cerebral hemorrhage, pulmonary or gastrointestinal bleeding
* Hypersensitivity of aspirin, clopidogrel or contrast media
* Pregnant woman or possibility of pregnancy during clinical study period
The Ultracyt Study - is EU-TIRADS Useful in Selecting Nodules for Fine Needle Aspiration Cytology?

This is a randomized study evaluating selective fine-needle aspiration cytology based on structured ultrasound using EU-TIRADS versus non-selective ultrasound guided cytology. Primary outcome is frequency of suspicious cytology (Bethesda III-VI) which is expected to be higher in the selective group compared to the non-selective group. Secondary outcome is the frequency of malignancy which is expected to be equal in both groups. However, the investigators do not expect to reach statistical significance for the secondary outcome according to power calculations.

Thyroid nodules are common in the population, and the reported incidence of thyroid cancer is increasing in most parts of the world. Palpable thyroid nodules are reported in 4-5 per cent of the population, of which 5-10 per cent are malignant. The reported incidence of thyroid nodules on ultrasound is higher.

EU-TIRADS has been shown in retrospective cohort studies to accurately stratify thyroid nodules with respect to risk of thyroid cancer. EU-TIRADS has been used in Western Sweden since 2017 and in 2021 it was implemented in the Swedish National Guidelines for thyroid cancer. To the knowledge of the investigators, no randomized controlled study has been carried out validating EU-TIRADS. This multicenter regional study aims to investigate the safety of using selective cytology using EU-TIRADS. Primary outcome is the result of cytology suspicious of thyroid cancer. In the selective group, low risk nodules will not undergo cytology and therefore the frequency of cytologically suspicious nodules (Bethesda III-VI) is expected to be higher in this group.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to ultrasonography of the thyroid due to goiter symtoms or positive findings on FDG-PET

Exclusion Criteria:

* Patients previously examined with ultrasonography of the thyroid
* Patients who have previously undergone thyroid surgery
Pallidal Stimulation and Gilles de la Tourette Syndrome

The aim of this study is to evaluate the efficacy and safety of bilateral pallidal stimulation in patients with a severe form of Gilles de la Tourette syndrome.

It acts of a randomized study, in parallel, double group blind, multi-centric relating to 14 patients.

The interest of this multicentric study, which will be carried out in centers specialized in the field of major cerebral stimulation with for each one a multidisciplinary team, is to carry out a homogeneous protocol which should make it possible to give a clear response in term of effectiveness for this treatment in this pathology.

The evaluation will be:

1. neurological (YGTSS, video scale of the tics);
2. psychiatric, with in particular of the specific psychopathological evaluations centered on mood;
3. neuropsychological, centered on impulsiveness;
4. functional calculus evaluating total operation and the social adaptation;
5. neurophysiological (recording of the neuronal activities).

Calculations of the number of subjects necessary showed, by laying down the principal objective at an improvement of at least 60 % of the score of the YGTSS under treatment, which 14 subjects will make it possible to show a significant difference with the procedure placebo.

Study in Tomography by Emission of Positrons (Mtoe) carried out on 8 of the 14 operated patients having had at least 3 months of stimulation, in comparison on 8 pilot subjects (paired for the sex and the age), should make it possible to determine, at the time of the improvement of the driving symptoms, modifications of cerebral activation induced by the high frequency stimulation of GPI among patients.

The association of this study to the comparison of the improvement of the neurological symptoms with the precise localization of the therapeutic stud of the electrode reformatted on the post-operative TDM (8), carried out for all the patients, should make it possible to specify the anatomy-physiological bases to specify the anatomy-physiological bases of the MGT The duration of the study will be 14 month for each patient, that is to say one 2 months preoperative period intended for inclusion; one 3 months post-operative period without stimulation; one period randomized with stimulation either "one" (3 months), or "off" (3 months), then an open study for all the patients with stimulation "one" for one 6 months duration.

It is envisaged to include 14 patients reached of the MGT (of which 8 will take part in study Mtoe) and 8 subjects controls for study Mtoe is 22 subjects.

An observational follow-up at 30 and 48 months is added.

Eligibility Criteria:
Inclusion Criteria:

* Severe form of GTS
* age 18 to 60 years
* failure of medical treatment (including neuroleptics)

Exclusion Criteria:

* Major depression
* Psychotic symptoms
* Severe personality disorder