cyrilzakka/clinical-trials huggingface dataset:
Simvastatin Treatment of Patients With Acute Optic Neuritis

The purpose of this study is to investigate if the simvastatin treatment improve the visual function after 3 months of the inclusion to this project and if the simvastatin influences the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the development of new demyelinating relapses. In the patients with monosymptomatic acut optic neuritis to investigate whether the simvastatin reduces the risk to develop multiple sclerosis (MS).

Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease in the Central Nervous System (CNS). Acute optic neuritis is a common symptom of MS and is considered to have the same pathogenesis as MS, where autoimmune and inflammatory mechanisms lead to the progression of MS.

Statins reduce the cholesterol in blood and in addition have anti-inflammatory effects. From experimental data and results from pilot projects there is evidence that the statins perform anti-inflammatory and immune-modulatory effects and one can expect a beneficial outcome in the autoimmune inflammatory diseases after the treatment with statins.

Eligibility Criteria:
Inclusion Criteria:

* Acute Optic Neuritis
* Abnormal contrast sensitivity score (\>80)
* Symptom duration maximum 4 weeks
* Men and women between 18 and 59 years old
* The patient must be physical and mental able to participate i this project with a 6 months of the duration
* The patient must sign the written consent of the participation before the inclusion.

Exclusion Criteria:

* Optic neuritis earlier in the same eye
* Pregnancy
* Nursing
* Fertile women who do not use contraception
* Women who contemplate pregnancy in the duration of the study
* Steroid treatment the last 4 weeks before the inclusion
* Immune-supressor treatment the last 6 months before the inclusion
* Active liver disease or continuous increase of liver enzymes (ASAT, ALAT)without known reason.
* Kidney failure
* Myopathy
* Hyperthyroidism
* Diabetes mellitus
* Alcoholism
* Fibrates intake
* Statin treatment for other disease
* Simultaneous participation in other studies.
Replagal Enzyme Replacement Therapy for Adults With Fabry Disease

This study will determine the safety and effectiveness of the drug Replagal for treating people with Fabry disease, an inherited metabolic disorder. In this disease, an enzyme called alpha-galactosidase A, which normally breaks down a lipid (fatty substance) known as ceramidetrihexoside, is missing or does not function properly. As a result, the lipid accumulates in the body, causing problems with the kidneys, heart, nerves, and blood vessels. This study will examine whether replacing the missing alpha-galactosidase A with a genetically engineered form of the enzyme called Replagal can reverse the illness.

Patients with Fabry disease who are 18 years of age or older and have completed 10 weeks of Replagal therapy as participants in protocol TKT027 may be eligible for this 6-month study extension.

Participants undergo the following tests and procedures:

* Intravenous (IV) infusions of Replagal every other week over 25 weeks for a total of 13 infusions, with close monitoring during and after the infusions.
* Brief safety evaluations at the time of each infusion, including a check of vital signs (blood pressure, pulse, breathing rate, temperature), review of any side effects, and review of medications.
* Comprehensive evaluations at baseline (before starting Replagal therapy), after 13 and 25 weeks of therapy, and 30 days after completing therapy. These include a medical history and physical examination, symptoms and pain questionnaire, blood and urine tests, check of vital signs, electrocardiogram (EKG), 2-hour Holter monitor, and sweat test (QSART).

Objectives: To evaluate the safety of the current standard Replagal treatment regimen of 0.2 mg/kg given intravenously every two weeks over an additional 6 months in patients who have completed 10 weeks of Replagal therapy in the TKT027 study.

Study Population: Hemizygous males with Fabry disease who are 18 years of age or older who have completed 10 weeks of Replagal therapy in TKT027.

Design: This is an open-label, multi-center study that will assess the safety of 0.2 mg/kg every two weeks of enzyme replacement therapy with Replagal.

Eligibility Criteria:
INCLUSION CRITERIA:

Subject must have completed 10 weeks of infusions in Study TKT027 with intent to complete participation in the study.

Subject must have adequate general health (as determined by the investigators) to undergo the specified phlebotomy regimen and protocol related procedures.

Subject must consent to participate in the protocol and must have voluntarily signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.

EXCLUSION CRITERIA:

Subject is unable to understand the nature, scope, and possible consequences of the study.

Subject is unable to comply with the protocol, e.g., uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for safety evaluations, or is otherwise unlikely to complete the study, as determined by the investigator or the medical monitor.
Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

To evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary, Written, and Signed Informed Consent: Agreeing to participate in the study.
2. Ability to Complete the Study According to Protocol: Able to meet the requirements of the study protocol.
3. Age: 18-65 years old.
4. Depression and Anxiety Scores:

   * Hamilton Depression Rating Scale (HAMD-17) score of 20 or higher, or
   * Hamilton Anxiety Rating Scale (HAMA) score of 14 or higher.
5. No History of Certain Conditions: No history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities.

Exclusion Criteria:

1. Past Diagnosis of Certain Conditions: Individuals with a history of other clearly diagnosed psychiatric disorders, intellectual disabilities, consciousness disorders, complete aphasia, bipolar disorder, treatment-resistant depression, or suicidal thoughts.
2. Pregnant or Breastfeeding Women: Individuals who are pregnant or breastfeeding.
3. Use of Certain Medications: Individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month.
4. Allergy History: Individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases.
5. Substance Abuse History: Individuals with a history of alcohol or psychoactive substance abuse within the past 3 months.
6. Impact of Medications on Gut Microbiota: Individuals who have used medications affecting gut microbiota (including antibiotics, probiotics, mucosal protectors, traditional Chinese medicine, etc.) continuously for more than 1 week in the month prior to screening.
7. Discontinuation or Addition of Medications: Individuals who have stopped taking the study medication or started taking other medications, making it difficult to assess efficacy or with incomplete data.
8. Use of Similar Products: Individuals who have taken items similar to the study product in the short term, affecting the evaluation of results.
9. Inability to Participate: Research participants who cannot participate in the study due to personal reasons.
10. Other Exclusions: Participants deemed unsuitable for the study by the researchers.
Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space

In this study, 5 subjects will be enrolled and the cumulative D2cc dose for rectum during brachytherapy will be recorded as the primary outcome measures.

This is a phase I prospective study of 5 patients to determine if PEG hydrogel (ReSpace™) reduces the radiation dose delivered to the rectum during radiation therapy for cervical cancer by increasing the space between the cervix and the anterior rectal wall. In the other word, the purpose of this study is to assess whether the use of ReSpace™ hydrogel results in a reduction of radiation exposure to the anterior rectum.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.
* Karnofsky score ≥ 70.
* Subjects aged ≥ 18 years and ≤ 75 years.
* Subjects must be able to cooperate in completing the entire study.
* The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.
* No contraindications to CT scanning.
* Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form.

Exclusion Criteria:

* Subjects who have received prior pelvic radiotherapy.
* Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.)
* Subjects with other primary malignancies
* Subjects with contraindications to radiotherapy, as determined by the investigators
* Subjects with injection site infections.
* Subjects who are allergic to the ingredients of the device.
* Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators
* Persons with severe mental illness, cognitive impairment and thinking disorders.
* Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening
* Pregnant or lactating women or those who plan to get pregnant within the last six months
* Subjects who cannot be followed up as prescribed by the doctor
* Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollment
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.

This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1301 in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan;
2. Age ≥ 18 years old and ≤ 75 years old, male or female;
3. Patients with locally advanced or metastatic malignant solid tumours that cannot be surgically resected as histologically or cytologically confirmed by standard therapy failure or refusal or inability to tolerate standard treatment regimens.
4. Agree to provide archival or fresh tumour tissue for immunohistochemical evaluation for immunohistochemical detection of CLDN18.2 expression.
5. Eastern Cooperative Oncology Group (ECOG) Strength Status Score of 0 or 1.
6. At least one evaluable lesion according to the efficacy evaluation criteria for solid tumours (RECIST1.1).
7. Adequate organ function.
8. Estimated survival ≥ 3 months;
9. Negative blood pregnancy test result for females of childbearing potential at screening.

Exclusion Criteria:

1. Poorly controlled hypertension as judged by the investigator
2. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC drug therapy, major surgery, or other anti-cancer therapy within 28 days prior to the first dose of trial drug.
3. Known hypersensitivity to any ingredient of the therapeutic drug used in the study protocol;
4. Positive hepatitis B virus surface antigen (HBsAg) test; Positive hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody;
5. Pregnant or lactating females, those who have recently planned to become pregnant;
6. Those who have participated in and received any clinical trial drugs (excluding vitamins and minerals) or clinical trial device intervention within 28 days before signing informed consent;
7. Other serious physical or psychiatric illness or laboratory test abnormalities at screening that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.
A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban

The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.


Eligibility Criteria:
Inclusion Criteria:

* Reasonably healthy men and women aged 50 to 75

Exclusion Criteria:

* History of abnormal bleeding, active bleeding or risk factors for bleeding
* History of thrombosis or risk factors for thrombosis
* History of adult asthma or use of inhaled medications
A COMPARATIVE STUDY BETWEEN 1MG AND 3 MG OF GRANISETRON IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN STRABISMUS OPHTHALMIC SURGERIES DURING GENERAL ANESTHESIA

Investigators aim to determine the optimal dose of granisetron in strabismus ophthalmic surgeries under general anesthesia to prevent postoperative nausea and vomiting

Postoperative nausea and vomiting (PONV) are common and distressing symptoms after surgery under general anesthesia. Despite advances in balanced anesthesia in recent decades, PONV can result in delayed discharge from the Post-Anesthesia Care Unit (PACU) recovery room, unexpected hospitalization and increase in medical costs.

The latest class of antiemetic for the prevention and treatment of PONV are the serotonin receptor antagonists (ondansetron, granisetron). These antiemetics do not have the negative effects of the older generations. Headache and dizziness are the main adverse effects of the serotonin receptor antagonists in the dosages used for PONV .

The FDA approved dose for the prevention of PONV is 1mg. This is based on a dose range study from Wilson and associates in which 0.1, 1.0, and 3.0 mg were associated with risk ratios for postoperative vomiting. The majority of studies on granisetron suggest that 3mg is superior to 1mg for the prevention of PONV, but those were published by a single center and there have been serious concerns about the validity of the data. In previous studies done on elective open abdominal surgery or vaginal hysterectomy but not in strabismus ophthalmic surgeries.

The ocular surgery associated with the highest incidence of PONV is strabismus surgery up to 85%. Vomiting after surgery is more likely 2-8hours than immediate postoperatively. Strabismus is a day case procedure and thus participants have to cope with emesis in the recovery room, or when traveling, or at home.

In this study, investigators compared two doses of granisetron in strabismus ophthalmic surgeries under general anesthesia

Eligibility Criteria:
Inclusion Criteria:

* • Adult patients \> 18 years old.

  * ASA I and II.
  * Patients scheduled for strabismus surgery.

Exclusion Criteria:

* • ASA class \> II.

  * Patients with known hypersensitivity or contraindication to any of the study medications.
  * Patients who had chronic nausea and vomiting or experienced retching, vomiting, moderate to severe nausea in the preoperative day.
  * Patients who had received an antiemetic drug in the preoperative day.
  * Patients with a body mass index ≥36.
  * Pregnant or breast feeding female patient.
  * Patients with gastrointestinal diseases.
  * Patients with a history of motion sickness, diabetes mellitus, and GIT pathology (gastritis, hematemesis, peptic ulcer).
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery

Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing heart surgery on cardiopulmonary bypass.

Exclusion Criteria:

* Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
* End-stage renal disease.
* Inability to give informed consent.
UTI Prophylaxis Using Bacterial Interference Following SCI

Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered benign colonizers and are often left untreated because they may afford some protection against symptomatic infection with more harmful bacteria.

We applied the concept of using benign bacteria to prevent symptomatic infection, so-called bacterial interference, by deliberately colonizing the bladder of patients with SCI with a non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our VA-funded study that compared the rates of symptomatic UTI in patients with SCI while colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study enrollment indicated that deliberate colonization of the bladder of patients with SCI with E. coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However, before this innovative approach of bacterial interference can be successfully applied in the population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of bacterial interference by conducting a prospective, randomized, placebo-controlled clinical trial (objective #1); and (B) enhance the practicality of applying this innovative approach in SCI patients by delineating the bacterial and host factors that can promote successful colonization with E. coli 83972 (objectives #2-3).

A prospective, randomized, placebo-controlled clinical trial will be conducted. Patients who had sustained SCI \>18 months earlier, suffer from neurogenic bladder (require intermittent bladder catheterization, an indwelling suprapubic catheter, or an external collection device), and have a history of frequent symptomatic UTI (\> 2 episodes during the preceding year) will be eligible for enrollment. Exclusion criteria will include urolithiasis, indwelling nephrostomy catheter, indwelling transurethral foley catheter, supravesical urinary diversion, vesicoureteral reflux, conditions anticipated to require antibiotic therapy for chronic recurrent extraurogenital infections (e.g. infected decubitus ulcers), uncontrolled diabetes mellitus and immunosuppression. Patients considered unreliable to pursue adequate follow-up and those incapable of giving informed consent will also be excluded. Subjects will discontinue all measures to suppress UTI for at least two weeks prior to entry into the study. All patients will have a complete history and physical examination, serum creatinine, plain X-ray of the abdomen (KUB), and urine culture immediately prior to entry into the study. Renal ultrasound and urodynamic evaluation of the urinary tract will also be obtained upon study entry unless they have been performed during the preceding year.

Eligibility Criteria:
Inclusion Criteria:

SCI UTI

Exclusion Criteria:
Oxycodone in Treatment of Early Labour Pain Efficacy and Safety

Oxycodone is used to treat early labour pain instead of meperidine. However, the efficacy and effects of oxycodone to the newborn has not been studied. In the present study, patient who has received oxycodone is asked about pain relief and after labour single venous blood sample from the parturient and umbilical cord are taken for the analysis of oxycodone.


Eligibility Criteria:
Inclusion Criteria:

* Oxycodone for pain relief
* age 18 years or more
* given informed consent

Exclusion Criteria:

* no oxycodone
* age less than 18 years
* no informed consent
An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.


Eligibility Criteria:
Inclusion Criteria:

* Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-09
* Are 18 to 75 years of age
* Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
* Are able to provide written informed consent

Exclusion Criteria:

* Have a major medical problem
* Have a history of an allergic reaction to CORLUX (C-1073, mifepristone)
InPractice Survey on the Treatment of Hypercholesterolemia

This is a multi-centre survey of patients who are currently on lipid-lowering pharmacological treatment. Data collection for each patient will take place at one visit.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older of either sex.
* Subject is on lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.
Costs of Complications in Inguinal Hernia Repair

Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of short-term advantages compared to open hernioplasties with mesh. In the prevailing economic climate, the total costs of treatment is a subject of intense research. This study is designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a special emphasis in costs of treatment, complications and convalescence.


Eligibility Criteria:
Inclusion Criteria:

* patients treated surgically for inguinal hernia between 2002-2011

Exclusion Criteria:

* none
Escitalopram in Adult Patients With Major Depressive Disorder

This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
* The patient's current depressive episode must be at least 8 weeks in duration.

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
* Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
* Patients who are considered a suicide risk
* Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.