cyrilzakka/clinical-trials huggingface dataset:
Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation

investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium.

A number of studies showed that premedication with melatonin was associated with sedation without impairment of cognitive and psychomotor skills or prolonging recovery. Some studies demonstrated that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time

The effects of the oral administration of melatonin on the dose of propofol sedation in participants undergoing loco-regional chronic subdural hematoma evacuation have not been documented before.

The present study will be conducted to detect the efficacy of oral administration of melatonin on the reduction of the sedative dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation.

Eligibility Criteria:
Inclusion Criteria:

* 50 -65 years
* ASA grade I to II
* Both sexes
* Patients with unilateral chronic subdural hematoma
* Patients who are vitally stable
* Glascow coma scale 14-15

Exclusion Criteria:

* Age below 50 and above 65 years.
* Gastro intestinal tract impractabililty.
* Patients with any substance abuse.
* Patients with hepatic or renal insufficiency.
* Patients on antipsychotic, anticonvulsant or anti-parkinsonian medication.
* Vitally unstable patients who cannot tolerate propofol sedation.
* Patients with known allergies to any of the drugs used.
The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery

Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial function under ANH and AHH, as the procedure is associated with moderately high blood loss. As the technique has not yet been described in this setting, investigators designed a pilot study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during perioperative period, with the intent of proceeding to a randomized trial if results were favorable.

Using a computer-generated random number table, patients were randomized to three groups: Control Group(n=30), ANH Group(n=30) and AHH Group(n=30). Patients underwent standard preoperative preparation for cytoreductive surgery according to institutional standards.All patients who underwent a standard anesthesia protocol and similar surgical procedures were considered for the analysis. For this purpose, investigators only included patients who underwent the following interventions: radical hysterectomy, bilateral adnexectomy, one or more bowel resection, peritonectomy, pelvic lymphadenectomy and extended periaortic lymphadenectomy. The patient would be ruled out of the experiment when the participant was accompanied with any kind of serious complications such as wakening delay and drug allergy.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of advanced primary epithelial ovarian
2. No comorbidities nor functional limitations (ASA Grade II due to high tumor load)
3. Serum hemoglobin (Hb) before surgery ≥ 11g/dl
4. Hematocrit (Hct) ≥ 35%
5. Quantity of platelets ≥ 100 × 109 /L

Exclusion Criteria:

1. Age \<18 or \>65 years
2. Body mass index \<20 and \>30 kg/m2
3. Duration of surgery \<180 min
4. Severe cardiovascular disease, liver and kidney disease
5. Thromboembolism history
A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™

The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* BMI\< 40 kg/m2
* Indication suitable to the implantation of Delta TT acetabular cup (First implant)
* Idiopathic osteoarthritis
* Avascular necrosis
* Post-traumatic arthritis
* Presence of sufficient periacetabular bone stock
* Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups
* Written informed consent

Exclusion Criteria:

* Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
* Patients aged 76 or older
* Haemophilic disease
* Femur neck fracture
* Insulin Dependent Diabetes Mellitus (IDDM)
* Severe kidney failure (grade 4)
* Not responder Hypo- or Hyperthyroidism
* Paget's disease
* Tumours
* Active or suspicious infections
* Neurosensory deficits or neuromuscular diseases
* Severe and impairing vascular diseases
* Known incompatibility or allergy to products materials
* Woman with pregnancy or childbearing capacity or breast-feeding
* Subjects already enrolled in other clinical trials
Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols

investigating the effect of glazing and polishing on the color difference between natural teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate ceramic).

Two groups of patients will be selected according to special inclusion criteria N=5 in each group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of the same material , after crowns delivery color difference (ΔE) between the natural teeth and the celtra press crown will be measured by a spectrophotometer device (intra oral) and patient satisfaction will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
* Patients able physically and psychologically to tolerate conventional restorative procedures.
* Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
* Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
* Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled or fractured.
* Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth.
* Patients with poor oral hygiene and motivation.
* Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
* Patients with psychiatric problems or unrealistic expectation
* Deep discoloration of abutment .
Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus

The Phase 1b study is a multi-center trial designed to test the safety, tolerability, biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2 diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or 10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses. The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a secondary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Body mass index not exceeding 32.0 kg/m2
* If female, subject must meet one of the following criteria: a) surgically sterile (hysterectomy or bilateral tubal ligation) OR b) at least two years postmenopausal OR c) using a dual method of contraception and have a negative serum pregnancy test if of childbearing potential
* Diagnosis of type 1 or type 2 diabetes according to the American Diabetes Association
* Fasting plasma glucose of ≥ 126 mg/dL or current treatment with oral hypoglycemic agents or insulin
* Microalbuminuria defined as albumin to creatinine ratio in a spot collection (first void) of 30 - 300 mg/gram confirmed by two samples two to three days apart
* Serum creatinine of no more than 1.5 mg/dL for men and no more than 1.1 mg/dL for women

Exclusion Criteria:

* Female subjects who are pregnant or lactating
* Non-diabetic renal disease
* History of allergic or anaphylactic reaction to human, humanized, chimeric, or murine monoclonal antibodies
* Coronary artery bypass graft surgery, myocardial infarction, cerebrovascular accident, percutaneous transluminal angioplasty, transient ischemic attack, history of unstable angina, known heart failure, uncontrolled cardiac arrhythmia, or uncontrolled hypertension within six months prior to Day 0
* Bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal
* History of cancer of any type in the past 5 years, except non- melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
* Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study
* Trauma or surgical procedures (including dental) within six months prior to Day 0
* Planned elective surgery during the study and for 3 months following the end of the study
* Participation in studies of investigational drugs within 6 weeks prior to first dose
POEM Versus Pneumatic Dilatation in Achalasia Cardia

The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.

Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
2. Age 18-75 years
3. Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study

Exclusion Criteria:

1. Severe comorbid illness
2. Previous esophageal or gastric surgery
3. Pseudo achalasia
4. Achalasia with esophageal diverticula
5. Pregnancy or lactation
Decompressive Cervical Surgery and Hypertension

There is a relationship between CSM and hypertension, probably a cause/effect relationship, and investigators term this type of hypertension "cervicogenic hypertension". Abnormally functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate and inhibit parts of the central and autonomic nervous systems as part of a chronic stress response, which causes hypertension and migraine. This theory is now being expanded to encompass both CSM and essential hypertension, the idea being that these two conditions are intimately related.

Cervical spondylotic myelopathy (CSM) and hypertension are both very common diseases in the general population.Investigators have also observed previously hypertensive patients with CSM become normotensive following decompressive cervical surgery and no longer need antihypertensive medications. Both observations are difficult to explain according to current theories of the two diseases.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of cervical spondylosis myelopathy
* Be at least 18 years of age
* Office-measured systolic BP≧140mmHg
* Ability to adhere to study protocol
* Have signed an approved informed consent form for participation in this study

Exclusion Criteria:

* Have hypertension secondary to a treatable cause
* Have prior cervical spine surgery
* Are pregnant or contemplating pregnancy during the 3-month follow-up period
* People deny to join the study
* Are unable to comply with protocol requirements
* Are unlikely to survive the protocol follow-up period
* Are enrolled in another concurrent clinical trial
* Visual Analogue Scale≥4
Defining COVID-19 Infection Severity on Presentation to Hospital

In the assessment of severity in coronavirus disease 2019 (COVID-19), the modified Brit_x0002_ish Thoracic Society (mBTS)，CURB65 et al. rules identifies patients with severe pneumonia but not patients who might be suitable for home management. A multicentre prospective study was conducted to derive and validate a practical severity assessment model for stratifying adults hospitalised with COVID-19 into different management groups.

1. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
3. The following is the general sequence of events during the 30-day evaluation period:
4. Completion of baseline procedures Participants were assessed for 30 days and completed all safety monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition);
2. Participants are willing to participate in this study and follow the research plan;
3. Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website.

Exclusion Criteria:

1. pneumonia was (a) not the primary cause for hospital admission, (b) an expected terminal event,or (c) distal to bronchial obstruction;
2. patients with tuberculosis,bronchiectasis,solid organ and haematological malignancies or human immuno deﬁciency virus (HIV) infection;
3. patients who had been in hospital within the previous 14days, were immunocompromised,or had previously been entered in the study;
4. nursing home residents.Participation in other clinical study.
Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue

The overall goal of this project is to quantify the long-term effects of dutasteride on the architectural and nuclear features of benign prostate tissue, using state-of-the art digital image analysis techniques. The ultimate result will be a multivariable morphological "signature" that could provide a useful indicator of an individual's degree of drug response.


Eligibility Criteria:
Inclusion Criteria:

* completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)
* compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline
* subgroup: Year 2 biopsy blocks and HE slides available for Aim 4a

Exclusion Criteria:

* N/A
Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

The objective of this study is to compare the peak dose relative bronchoprotection offered by levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

1. Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent
2. Methacholine responsive PC20\< 4 mg/ml
3. \>1dd change in methacholine PC20 after the administration of racemic Salbutamol.
4. Male or female 18-65
5. Informed Consent
6. Ability to comply with the requirements of the protocol

Exclusion Criteria:

1. Severe asthmatics as defined by an FEV1≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
2. The use of oral corticosteroids within the last 3 months.
3. Recent respiratory tract infection (2 months).
4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
5. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
6. Any significant abnormal laboratory result as deemed by the investigators
7. Pregnancy, planned pregnancy or lactation
8. Known or suspected contra-indication to any of the IMP's
9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh

This study is conducted in Asia. The aim of this non-interventional study is to evaluate the the current status of diabetes management, control, and complications in diabetic subjects with type 2 diabetes in Bangladesh.


Eligibility Criteria:
Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy
L-Arginine, Symmetrical and Asymmetrical Dimethylarginine (SDMA/ADMA) in Acute Kidney Injury (AKI)

The purpose of the study is to determine the association between acute kidney injury and serum levels symmetrical and asymmetrical dimethylarginine (SDMA/ADMA) and their assumptive influence on mortality, renal function and on arterial stiffness.

Acute kidney injury (AKI) is a frequent complication with severe implications deteriorating overall prognosis. Nitric oxide (NO)-signal transduction plays an important role in mediating renal damage. NO is produced by NO-synthase (NOS) with L-arginine as its substrate. Endogenous L-Arginine derivatives, asymmetric and symmetric dimethylarginines (ADMA/SDMA), inhibit NO-production directly (AMDA) by blocking NOS activity or indirectly (SDMA) by blocking cellular L-Arginine uptake.

It is well known that SDMA and ADMA are markers of renal function (SDMA) and cardiovascular risk (ADMA/SDMA) in patients with chronic kidney disease (CKD). Moreover, ADMA and SDMA possibly even trigger cardiovascular risk in patients with CKD. However, there is only little information about the regulation and the influence of ADMA/SDMA in acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
* no started renal replacement therapy (e.g. dialysis)

Exclusion Criteria:

* dialysis or continuous venovenous hemofiltration before recruitment
* no recovery from kidney injury according to the definition of AKIN (Acute Kidney Injury Network)
* palliative care
* life expectancy is severely limited (\< six months) due to preexisting malignancy or other disease
Brain Oxygenation During Cardiopulmonary Resuscitation

The study is aimed to assess (a) the incidence of hyperoxia at the point of return of spontaneous circulation (ROSC) and (b) the role of arterial blood oxygen partial pressure to brain oxygenation during out-of-hospital cardiac arrest. 80 adult patients will be recruited in a physician staffed helicopter emergency medical services. Brain regional oxygen saturation and invasive blood pressure are monitored until hospital admission and arterial blood gases are analyzed immediately when the unit arrives to the patient and again at the time of ROSC.


Eligibility Criteria:
Inclusion Criteria:

* out-of-hospital cardiac arrest of presumed cardiac origin
* resuscitation will be continued at least 5 minutes (if return of spontaneous circulation not achieved earlier) after arrival of physician team

Exclusion Criteria:

* do-not-attempt-resuscitation (DNAR) order or withdrawal of treatment by prehospital critical care physician
* return of spontaneous circulation achieved before physician-led critical team arrives
* external cause for cardiac arrest (e.g. trauma, suffocation)
* workload too high or environment too dangerous to perform study procedures
Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea

This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria of primary dysmenorrhea in the Primary Dysmenorrhea Consensus Guideline;
* meeting the diagnostic criteria of Hanning-xueyu(blood stasis due to cold accumulation) Zheng according to Gynecology of Chinese medicine;
* with regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 9 days in the last 6 months;
* course of dysmenorrhea over 6 months;
* experienced menstrual pain scoring varying from 3cm to 6cm on a 10-cm VAS during the baseline menstrual period (one period prior to present menstrual period with treatment);
* without history of pregnancy;
* with agreement of informed consent and a working phone.

Exclusion Criteria:

* history of abdominal surgery;
* with other acute or chronic painful conditions diagnosed or suspected;
* use of hormonal contraceptives, or intra-uterine device;
* use of analgetic drugs or other analgetic treatment in the last 2 weeks;
* known allergy to Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi) or Wuyao(Lindera Aggregata);
* prone to allergy in daily life;
* who can not complete treatment adherence to the protocol;
* attending in other trials in the last 3 months.