cyrilzakka/clinical-trials huggingface dataset:
A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy

The study is being conducted to evaluate the efficacy and safety of SHR3680 plus androgen deprivation therapy (ADT) vs. placebo plus ADT in patients with high-risk localized or locally advanced prostate cancer using pathologic complete response (pCR) rate and metastasis-free survival (MFS).


Eligibility Criteria:
Inclusion Criteria:

1. Age of ≥ 18 years old;
2. ECOG PS score of 0 or 1;
3. Pathologically diagnosed as prostate adenocarcinoma;
4. High-risk patients
5. No distant metastasis (clinical staging of M0) as determined by BICR of imaging examinations;
6. Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy);

Exclusion Criteria:

1. Subjects who received any prior treatment for prostate cancer, except medical ADT and/or first-generation androgen receptor antagonists (such as bicalutamide) for not more than 4 weeks;
2. Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization;
3. Subjects who are planning bilateral orchidectomy during the treatment period of the study;
4. Subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption;
5. Subjects with a history of epilepsy, or diseases that can induce seizures occurred within 12 months prior to randomization (including a history of transient ischemic attack, stroke, traumatic brain injury, and cognitive impairment, requiring hospitalization);
6. Subjects with active heart disease within 6 months prior to randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment;
Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block

The recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. It was supposed to be associated with increased intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients
* weighing less than 16 kg
* who receive caudal block before urologic surgery

Exclusion Criteria:

* Subjects are ineligible if they have contraindication for caudal block such as infection, coagulopathy, anomaly, or past medical history related to increased intracranial pressure
* ophthalmic disease
* expected operation time is less than 30 minutes
* both parents are unable to communicate or speak Korean.
Correlation of Hepatitis C, Alcoholic Liver Disease, and Renal Failure With Hyperfibrinolysis in Liver Failure

1. Further characterize the incidence of hyperfibrinolysis in cirrhotics
2. Correlate hyperfibrinolysis with

   1. hepatitis C
   2. alcoholic liver disease
   3. the subset of a\&b with renal failure with and without dialysis
3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics


Eligibility Criteria:
Inclusion Criteria:

* Be on the the liver transplant waiting list

Exclusion Criteria:

* liver failure without eligibility for transplant
Promethazine vs. Lorazepam for Treatment of Vertigo

This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Background history of positional vertigo

Exclusion Criteria:

* Unable to provide informed consent
* Pregnant or possibly pregnant
* Known allergy to study medications
* Use of antiemetic agents in the previous 24 hours
* Evidence of drug-induced vertigo or orthostatic hypotension
* Central pathologies/central origin for vertigo
Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial

The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.

This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation.

Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥ 18 years old
2. In need of sinus augmentation utilizing lateral window sinus technique
3. Presence of bone height of \< 8 mm
4. Patient has good oral hygiene (\<40% plaque score)
5. Periodontally stable
6. Willingness to fulfill all study requirements

Exclusion Criteria:

1. Currently smoking \> 10 cigarettes / day
2. Pregnant, expecting to become pregnant or lactating mothers
3. Uncontrolled Diabetes Mellitus (HbA1c \>7)
4. Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections)
5. Current use of oral bisphosphonates
6. History of IV bisphosphonates use
7. Poor oral hygiene (plaque score \>40% based on O'Leary plaque score)
8. Unmanageable Sinus perforations
9. Significant pathology in the region of interest that may compromise the procedure
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma

Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable outcomes in patients with numerous cancers, there has never been a thorough study of vitamin D treatment in subjects undergoing treatment for cancer. The purpose of this study is to evaluate whether modification of vitamin D levels in the blood, through supplementation, can improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

Each of the following criteria must be met in order for a patient to be considered eligible for registration:

* Biopsy proven (with hematopathology review at one of the participating sites to confirm correct histology in accordance with World Health Organization) indolent lymphoma to include the following diagnoses:

  * Grade 1, 2, or 3a follicular lymphoma
  * Small lymphocytic lymphoma (CLL excluded)
  * Marginal zone lymphoma (nodal or splenic)
  * Mucosal-associated lymphoid tissue
* Measurable disease defined by Lugano criteria
* No prior anti-lymphoma systemic therapy; prior radiation therapy allowed
* Age 18 or over
* Ann Arbor stages II, III or IV
* Patients with follicular lymphoma must have PET FDG-avid lymphoma and fulfill Low tumor burden by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:

  * No mass \> 7 cm
  * \< 3 distinct masses of greater than 3 cm
  * No B symptoms
  * No splenomegaly \> 16 cm by computed tomography (CT) scan
  * No risk of vital organ compression
  * No leukemic phase \> 5000/µl circulating lymphocytes (except for in patients with splenic marginal zone diagnosis)
  * No cytopenias (platelets \< 100,000/µl, hemoglobin \< 10 g/dl, or absolute neutrophil count \< 1500/µl)

Exclusion Criteria:

The following criteria will prevent inclusion of an inappropriate subject into the trial:

* Osteoporosis requiring prescription treatment
* Known symptomatic primary hyperparathyroidism
* Hypercalcemia defined as above the institutional normal range (corrected for albumin when albumin levels are below normal)
* History of calcium-related kidney stones
* Creatinine \> 1.5X above upper limit of normal
* Women who are known to be pregnant or who plan to become pregnant while on rituximab treatment
The Light- and Environment Project in Psychiatric Inpatient Care

The care environment influences both patients' experiences of care as well as staff's experiences of the work environment. A radical change in physical environment is planned at a psychiatric ward, aiming at creating a care environment that supports patients' opportunities for recovery from mental ill-health and to create a better and more attractive work environment for the staff. The rebuilding involves a new ward layout and new innovations such as light installations, a comfort room and an activity room.

The study uses a single-system design to evaluate the effects of the intervention - the rebuilt ward. Both quantitative and qualitative data will be used in the evaluation. Data will be collected using questionnaires measuring dimensions of patients' well-being and experiences of the care environment, staff's experiences of work-related stress and work environment, quality of care, a device measuring physical activity, existing clinical registers and data from medical files, staff' sick leave, participant observations, and semi-structured interviews.

This evaluation study, to our knowledge the first of it's kind in Sweden, is expected to generate important knowledge of the effect of the change process that can be used at other psychiatric wards to design the inpatient care environment. In the long run, the study could lead to a better reputation of psychiatric nursing and to more attractive workplaces.


Eligibility Criteria:
Inclusion Criteria for Patients

* 18 years or older
* Admitted to the wards during either A phase, B phase and/or follow-up

Exclusion Criteria for Patients

* Does not master the Swedish language well enough to complete questionnaires and participate in interviews

Inclusion Criteria for Staff:

* Regularly employed at the ward during A and B phase and/or follow-up.

Exclusion Criteria for Staff:

* Staff employed by the hour
Efficacy of Botox in Patients With Idiopathic Clubfoot

The purpose of this study was to determine the efficacy of adding Botox injection to serial manipulations and castings in patients with clubfoot. The study hypothesis was that the use of Botox in the setting of serial manipulations and castings is an effective treatment for clubfoot.

All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.

Eligibility Criteria:
Inclusion Criteria:

1. Children presenting with idiopathic clubfoot/feet at BC Children's Hospital
2. Children ranging in age from 1 day to 2 years old at initial treatment Children who have had previous intervention for their clubfoot (methods including surgery, Ponseti method, Kite method, physical therapy method) and had a clubfoot recurrence requiring re-intervention
A Diabetes Study to Treat A Population Previously Not at Target

This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 diabetes
* Previously treated with a commonly accepted start dose of a statin for the last 4 weeks prior to study entry
* Fasting LDL-C concentration of \> 2.0 mmol/L (and ≤ 5.0 mmol/L) (in the past 3 months)
* History of serum TG level of ≤ 4.6 mmol/l (in the past 3 months)

Exclusion Criteria:

* If currently receiving therapy with any statin at a dose higher than listed
* Rosuvastatin (current use)
* Fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to enrolment.
* Type 1 diabetes; glycated haemoglobin (HbA1c) \> 9.0%
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 1.5 × upper limit of normal (ULN) (in the past 2 months)
* Resting diastolic or systolic blood pressure of \> 95 mmHg or \> 180 mmHg, respectively (in the past 2 months)
* Unexplained serum creatine kinase (CK) level \> 3 × ULN (in the past 2 months).
MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease

This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
* 2.Male or female subjects must be at least 18 years old when signing the informed consent;
* 3.The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
* 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
* 5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;
* 6.Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable;
* 7.Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable;

Exclusion Criteria:

* 1.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
* 2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
* 3.The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2;
* 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg(Except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment;
* 5.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
* 6.Subjects with a history of malignant tumors within the past 5 years prior to screening;
* 7.Subjects are allergic or intolerant to any component of the investigational drug or Etelcalcetide
Eye Tracking Technology in the Diagnosis of Neurological Patients

Demonstrating that diagnostics of the state of consciousness and cognitive functions of patients with consciousness disorders performed using C-Eye X (based on eye-tracking technology) allows a more objective assessment of state of patients who were wrongly diagnosed based on popular methods using in a clinical practice (like behavioural scales on paper forms).

The aim of this Study is to perform a clinical evaluation of the authors' original battery of diagnostic tests in the C-Eye X system (based on eye-tracking technology), addressed to patients who have suffered damage to the central nervous system (CNS) with communication barriers. Validation is being conducting for 2 original diagnostic tests: MCSD (Minimally Conscious State Detection): to differentiate patients' state of consciousness (for patients diagnosed as being in unresponsive wakefulness syndrome (UWS) or minimally consciousness state (MCS) and CFA (Cognitive Functions Assessment) to assess the level of preserved cognitive functions in patients (for patients diagnosed as being in at least minimally consciousness state minus (MCS-). The intention of the project's authors is to introduce a novel diagnostic solution that will help reduce misdiagnoses made for neurological patients with reduced consciousness, due to the inadequacy of current behavioural tools to work with patients after severe brain damage.

Eligibility Criteria:
Inclusion Criteria:

1. Completed 18 years of age.
2. Consent of the legal guardian to participate in the Study and access to medical records.
3. Medical diagnosis indicating damage to the central nervous system.
4. Having and sharing a description of imaging tests (alternatively MRI - Magnetic Resonance Imaging or CT - Computed Tomography) and (alternatively) ophthalmoscopy, ophthalmology, auditory tests.
5. Presentation of a list of medications used by the patient that may affect the results obtained in tests of cognitive function.
6. Acceptance by a physician (e.g. neurologist, neurosurgeon, internist) to participate in a clinical trial, taken after reviewing the Study protocol, including there is a need to take into account:

   1. the ability to communicate only by sight (no verbal, sign or other communication),
   2. the absence of dementia and aphasic disorders before the event that led to CNS damage and the patient's current condition,
   3. preserved at least one functioning eyeball (possibility of cooperation with an eye tracker).

Exclusion Criteria:

1. Visual defect (refractive defect) diagnosed before the incident, requiring work with glasses with lenses of more than ±3 diopters.
2. Inclusion of drug treatment during the Study (observation), which can affect the patient's cognitive functioning (both in terms of cognitive enhancement and impairment/dementia).
Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus

60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing Quantitative real-time polymerase chain reaction and immunohistochemistry.

60 individuals were subdivided into 3 groups, into 2 groups, 30 patients with oral lichen planus, 30 control individuals having age, gender and periodontal status matched with both patients groups acting as a control group. Relative gene expression of miRNA-138 was estimated using Quantitative real-time polymerase chain reaction technique in oral mucosa of both oral lichen planus patients and control subjects. Sub grouping of oral lichen planus patients were performed into reticular, atrophic and erosive groups (n=10 each). Cyclin D1 gene expression was estimated using Quantitative real-time polymerase chain reaction technique and Cyclin D1 protein level was estimated using immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* patients with oral lichen planus.

Exclusion Criteria:

* any systemic disease other than oral lichen planus.
* smokers.
* pregnant females.
* periodontal diseases.
Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History

It remains unclear why some individuals are able to clear HBV from their bodies while in others HBV is a persistent infection. We plan to investigate this process by collecting blood and analysing how the patient's white blood cells respond to different pieces of the HBV virus. We will use new tools that can precisely tell us which component of the immune response may be different in individuals who are chronically infected with HBV and also in individuals who are also infected with HIV.

The primary aims are therefore:

1. To characterize HBV-specific T cell responses in HBV chronic carriers, and identify novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals.
2. To determine the effect of HIV infection on HBV-specific T-cell responses


Eligibility Criteria:
Inclusion Criteria:

There are two groups of patients in this study. Group A mono-infected with Hepatitis B, and those with co-infection HBV/HIV.

Group A inclusion criteria: (also split into 6 recruiting groups)

* Acute hepatitis B
* Chronic hepatitis B, HBV DNA+ve , normal ALT , HBeAg +ve
* Chronic hepatitis B, HBV DNA +ve , normal ALT, HBeAg -ve
* Chronic hepatitis , HBV DNA +ve, increased ALT, no HBV treatment B, HBeAg +ve
* Chronic hepatitis B, HBV DNA +ve , increased ALT, no HBV treatment B, HBeAg -ve
* Chronic hepatitis B, undergoing 'flare' of hepatitis

Group B inclusion criteria:

* To be HIV/HBV co-infected

All patients:

* To be over 18 years

Exclusion Criteria:

* Those who do not fit the inclusion criteria.
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
* hsCRP greater than 3mg/L
* Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria:

* Pregnant or breast feeding
* Short bowel syndrome due to multiple small bowel resections
* Presence of a stoma