cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.

Macular oedema remains a significant cause of blindness. Corticosteroids are effective in the treatment of sarcoid-associated macular oedema but more than 50% of relapses occur when corticosteroids are tapered. Methotrexate (MTX) at low dose has been shown to be an effective and safe steroid-sparing agent for lung sarcoidosis and compilation of reported small series of patients with sarcoid-associated uveitis suggest that only 25% of relapses could be achieved with low dose MTX. We decide therefore to test the clinical efficacy of MTX in sarcoid-associated uveitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Provided written consent for participation in the trial prior to any study-specific procedures or requirements
* Posterior uveitis or panuveitis associated with macular oedema defined as increased macular thickness (more than 250 mm assessed by Stratus TD-OCT or 300 mm with Cirrus SD-OCT ) and/or the presence of cystoid spaces in the macula, and the absence of epiretinal membranes.
* Patient with oral contraception
* Posterior uveitis or panuveitis associated with macular oedema
* Patients with histologically proven sarcoidosis or a presumed sarcoidosis. In case of a non caseating granuloma in biopsy tissues, the patients with presumed sarcoidosis meet at least 2 of the 4 following criteria: typical changes on chest radiography and computed tomography; predominantly CD4 lymphocytosis in bronchoalveolar lavage (BAL) fluid; elevated serum ACE levels; elevated gallium or 5 fluorodeoxyglucose uptake

Exclusion Criteria:

* Patients who do not fulfill the inclusion criteria
* Other causes of uveitis
* Extra ophthalmologic manifestations of sarcoidosis justifying corticosteroids
* Patients previously treated with immunosuppressive agents or corticosteroids of more than 10 mg daily over 15 days.
* Patients with life-threatening conditions
* Chronic hepatopathy or renal failure
* Uncontrolled diabetes mellitus
Bioinformation Therapy for Pancreatic Cancer

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable pancreatic cancer.

By enrolling patients with unresectable pancreatic cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest

To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent (obtained from their legal representative)
* 18 years of age or older and less than 80 years old.
* Witnessed OHCA of presumed cardiac cause
* Sustained ROSC (when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist)
* Initial shockable cardiac rhythm (documented by ECG or AED)
* Interval from collapse to advance life support \< 20 minutes
* Interval from collapse to ROSC \< 60 minutes
* Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
* Systolic blood pressure of \>90 maintained for a least 30 minutes post-ROSC without pressors, or with a stable dose of pressors

Exclusion Criteria:

* Traumatic cardiac arrest
* Toxicological etiology
* Known or suspected pregnancy
* Do Not Attempt to Resuscitate order in force
* Unwitnessed arrest
* In-Hospital arrest
* Anatomy, previous surgery or disease state contraindicating femoral venous access
* Received neuromuscular blocking agents prior to assessing level of consciousness following ROSC
* Neurological evaluation insufficient/incomplete after ROSC but prior to randomization.
* Body core temperature \< 34ºC at randomization
* Current Inferior Vena Cava (IVC) filter
* Known history of acute neurological illness or severe functional disabilities prior to arrest (e.g., seizures, traumatic brain injury, increased intracranial pressures, intra-cerebral hemorrhage, etc).
* Known hypersensitivity to hypothermia including a history of Raynaud's disease
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed acute stroke
* Terminal illness or life expectancy of less than 3 months prior to arrest
* Currently enrolled in another investigational new drug or device trial that has not completed the primary endpoint or that clinically interferes with this Trial's endpoints (For the purpose of this protocol, subjects involved in extended follow-up trials or registries for products that are currently commercially available are not considered enrolled in an investigational trial).
* Transferred from a non-participating hospital.
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 18 years of age
* Constipated, defined by the following adapted ROME II definition:

A. Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:

1. Straining during \> 25% of defecations
2. Lumpy or hard stools in \> 25% of defecations
3. Sensation of incomplete evacuation for \> 25% of defecations

B. Loose stools are rarely present without the use of laxatives

C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements

Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
* Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
* Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
* Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
* Subjects who are pregnant or lactating, or intend to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to any study medication component
* Subjects taking narcotic analgesics or other medications known to cause constipation
* Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
* Subjects with an active history of drug or alcohol abuse
* Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
* Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
* Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)
Fabry Disease in Cerebrovascular Disease

Fabry disease is an X-linked disorder of glycosphingolipid catabolism caused by a deficiency of the enzyme α-galactosidase A (α-Gal A), which leads to a progressive accumulation of globotriaosylceramide (Gb-3) in plasma and tissue lysosomes throughout the body. Lysosomal accumulation can result in lysosomal and cellular dysfunction, which leads to renal, cardiac, and central nervous system (CNS) complications.

It is estimated that 1 in 40,000 males has Fabry disease, whereas the estimated prevalence in the general population is 1 in 117,000 people. Newborn screenings for both classical and atypical Fabry disease in Taiwan also revealed a markedly high incidence of 1 in 2,300 and 1 in 3,000 newborns. Cerebrovascular variant Fabry disease may affect up to 4.9% of male patients and 2.4% of female patients with idiopathic stroke.

The diagnosis of Fabry disease can be challenging due to the diverse signs and symptoms, different ages of onset, and variable timing and severity of progression. The importance of Fabry disease lies in the irreversible renal, cardiac, cerebrovascular, and neurological damage. An early diagnosis of Fabry disease is important for initiating symptom management and reducing life-threatening complications, as well as for early identification of other affected family members. Therefore, the present study would like to conduct further screening of high-risk group of early cerebrovascular involvement that is essential for the successful management of Fabry disease.

This is a cross-sectional, population-based study to identify Fabry disease in patients with early cerebrovascular involvement. Eligible patients are age above 18 years old (\<=55 years old) with early cerebrovascular involvement and have provided inform consent. Patients who have been diagnosed Fabry disease are not eligible.

The present study will use samples of early cerebrovascular involvement patients which have been enrolled in two previous IRB approved projects \[103-3254C (origin 98-3889A3), 100-4008C (origin 97-0470B)\], participants of both studies have consented that participants' samples could be further investigated if needed.

Since, the investigators cannot ensure whether the condition of enzyme activity of frozen plasma sample were decayed after long-term storage and the investigators don't have available normal range of enzyme activity of historical plasma sample, the investigators will perform specific genotyping of Fabry disease for these patients according to the specific mutation variants which have been identified in Taiwan population previously.

Patients will be recalled to assess Fabry related symptoms if genetic testing has mutation finding and family screening will be performed if applicable. Further inform consent will be obtained as well.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 y/o
* Both females and males who have ischemic or hemorrhagic stroke before the age of 55 y/o
* Patient or his/her legal representatives are willing to sign the informed consent

Exclusion Criteria:

* Ischemic or hemorrhagic stroke patients who are already diagnosed to have Fabry disease
Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

Aneurysmal subarachnoid hemorrhage (SAH) is a fatal disease with high morbidity and mortality. While the primary injury results from the initial bleeding and cannot be influenced, secondary injury through vasospasms and delayed cerebral ischemia (DCI) during the course of the disease might be a target for intervention in order to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no causal therapy available, so that novel treatment concepts are desperately needed. There are strong indications that inflammation contributes to DCI and therefore poor outcome and plays a major role in SAH. Some studies suggest a beneficial effect of anti-inflammatory drugs like glucocorticoids (GC) in SAH patient, but there are no data from randomized controlled trials proving or disproving the beneficial effect of GC, so that current guidelines do not recommend the use of GC in SAH so far.

This multi-center trial aims to generate the first confirmatory data in a controlled randomized fashion that dexamethasone (DEX) improves the outcome in a clinically relevant endpoint in SAH patients. Moreover, this trial will generate first data in a secondary analysis, whether the initial inflammatory state of SAH patients defines a subgroup that particularly responds to a treatment with DEX.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, equal or older than 18 years old
2. Written consent to participate in the study by the patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the principal investigator is possible)
3. Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion.

Exclusion Criteria:

1. SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (AVM), fistula, dissection)
2. Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study
3. Patients with obvious evidence of irreparable brainstem or thalamic injury
4. Patients with foreseeable difficulties to attend follow-ups adequately
5. Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial
6. Current positive pregnancy test (e.g. β-HCG test in serum)
7. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
8. Severe infectious diseases
9. Known angle-closure or open angle glaucoma
10. Known ulceration in the gastro-intestinal tract
11. History of gastro-intestinal bleeding
12. Long-term treatment with corticosteroids prior SAH
Oblique Subcostal Transversus Abdominis Plane Block Versus Transmuscular Quadratus Lumborum Block for Pain Management in Laparoscopic Gynecological Surgery

Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular quadratus lumborum block (TQLB).

Patients between the ages of 18-65, who will undergo laparoscopic gynecological surgery, American Society of Anesthesiologists (ASA) class I-II-III, Body Mass Index (BMI) in the range of 18-25 kg/m², and who will use 3 or 4 trocar for surgery will be included in the study. Patients will be randomized into two groups. OSTAP block will be performed for OSTAPB group and TQL block will be performed for TQLB group. Patients will be administered postoperative 4x500 mg iv paracetamol as needed (if Visual Analogue Scale (VAS) score is 4 or higher). If the VAS score remains at 4 or higher 30 minutes after paracetamol administration, 1 mg/kg iv tramadol will be administered as a rescue analgesic (with a daily maximum dose of 400 mg). The primary outcome is to compare the total analgesic consumption within the first 24 hours after surgery. The secondary outcome is to compare the time to the first postoperative analgesic requirement, VAS scores at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QOR-15 scale

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-65
* Patients who will undergo laparoscopic gynecological surgery
* ASA I-II-III patients
* Body Mass Index (BMI) in the range of 18-25 kg/m²
* Patients who will undergo surgery using 3 or 4 trocars

Exclusion Criteria:

* ASA IV-V
* Patients with a known or suspected allergy to local anesthetics
* Coagulopathy
* Injection site infection
* Severe neurological or psychiatric disorders
* Severe cardiovascular disease
* Liver failure
* Kidney failure (glomerular filtration rate \<15 ml/min/m²)
* Chronic opioid use (\>6 months)
* Surgical durations less than 45 minutes or greater than 120 minutes
Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.

OBJECTIVES:

* Determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva.
* Determine the objective response rate and duration of response in these patients treated with this drug.
* Determine the acute side effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the vulva

  * Not suitable for radiotherapy or surgery as first-line treatment
* Measurable or evaluable disease

  * At least 1 bidimensionally measurable target lesion
  * Measurable metastatic disease outside previously irradiated areas OR
  * Local recurrence within a previously treated area OR
  * Local lesions showing progression while on treatment
* No brain metastasis

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2
* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* AST/ALT less than 2 times upper limit of normal

Renal:

* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* No prior or concurrent cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmia requiring medication, or 2nd or 3rd degree heart block)

Other:

* No peripheral neuropathy greater than grade 1
* No serious active infection
* No prior allergic reaction to drugs containing Cremophor EL
* No other serious medical, psychological, familial, or social condition that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy except as concurrent therapy with radiotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* See Chemotherapy
* No concurrent radiotherapy

Surgery:

* Not specified
A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments
* Histologic confirmation of the original primary tumor is required
* Histologic or cytologic confirmation of the recurrent/progressive disease is desired
* Patients must have had at least one but no more than two prior chemotherapeutic regimens for management of endometrial carcinoma
* Disease that is measurable per RECIST v1.1
* No active infection requiring antibiotics
* Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to first study treatment
* Any other prior therapy directed at the malignant tumor, including immunologic agents and radiotherapy, must be discontinued at least 2 weeks prior to first study treatment
* Adequate hematologic and end organ function

Exclusion Criteria:

* Type I diabetes or Type II diabetes requiring insulin
* Prior use of mTOR/PI3K inhibitor
* Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
* Previous diagnosis of pulmonary fibrosis of any cause
* History of myocardial infarction or unstable angina within 6 months prior to first study treatment
* Congestive heart failure
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease, including cirrhosis and current alcohol abuse
* Presence of positive test results for hepatitis B or hepatitis C
* Known HIV infection
* Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory drugs
* Need for current chronic corticosteroid therapy
* Pregnancy, lactation, or breastfeeding
* Current severe, uncontrolled systemic disease
* Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment
* Uncontrolled hypercalcemia
* Leptomeningeal disease as a manifestation of cancer
* Known untreated or active brain metastases
* Grade \>=2 hypercholesterolemia or hypertriglyceridemia