cyrilzakka/clinical-trials huggingface dataset:
Albuterol in Individuals With Late Onset Pompe Disease (LOPD)

Albuterol is a drug approved by the US Food and Drug Administration (FDA) for treating breathing problems such as asthma. Studies have shown that albuterol may be beneficial in improving muscle function in people with late-onset Pompe disease. The purpose of this study is to evaluate whether albuterol is safe and effective for improving muscle function in people with late-onset Pompe disease, whether or not they are receiving enzyme replacement therapy (ERT). For this study, albuterol is considered an investigational drug. The word "investigational" means albuterol is not approved by the FDA for individuals with late-onset Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Pompe disease by blood acid alpha-glucosidase (GAA) assay and GAA gene sequencing
2. Age: 18+ years at enrollment

Exclusion Criteria:

1. Continuous invasive ventilation (via tracheostomy or endotracheal tube)
2. Clinically relevant illness within two weeks of enrollment including fever \> 38.2o C, vomiting more than once in 24 hours, seizure, or other symptom deemed contraindicative to new therapy.
3. Chronic heart disease (Myocardial infarction, arrythmia, cardiomyopathy)
4. History of seizure disorder
5. Hypothyroidism
6. Pregnancy/Breast Feeding \[Women of childbearing potential must have a negative urine pregnancy test at each study visit. In addition, at Screening/Baseline women of childbearing potential must have been using a medically acceptable contraceptive for at least 3 months prior to study enrollment OR the subject a) has a regular menstrual cycle, b) Day 1 (onset of menses) for the current cycle is known, and c) the urine pregnancy test can be administered within the first two weeks of the current cycle (between Days 1 and 14)\]. The urine pregnancy test will be administered and interpreted by Stephanie Dearmey, Physician Assistant (PA-C), who has completed training from the Department of Obstetrics and Gynecology. Mrs. Dearmey will use a commercially available test kit specified by the point-of-care testing policies. If these criteria for urine pregnancy testing are not met at the Screening/Baseline visit, then a blood pregnancy test will be done.
7. Patients on a non-standard schedule for ERT; for example, weekly infusions as opposed to infusions every two weeks.

The use of the following concommitant meds is prohibited during the study:

* diuretics (water pill);
* digoxin (digitalis, Lanoxin);
* beta-blockers such as atenolol (Tenormin), metoprolol (Lopressor), and propranolol (Inderal);
* tricyclic antidepressants such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), and nortriptyline (Pamelor);
* Monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or
* other bronchodilators such as levalbuterol (Xopenex), bitolterol (Tornalate), pirbuterol (Maxair), terbutaline (Brethine, Bricanyl), salmeterol (Serevent), isoetherine (Bronkometer), metaproterenol (Alupent, Metaprel), or isoproterenol (Isuprel Mistometer).
Abraxane and Temodar Plus Genasense in Advanced Melanoma

This study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of combination treatment with Temodar®, Genasense®, and Abraxane® in chemotherapy-naïve subjects with advanced melanoma and normal lactate dehydrogenase (LDH).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with progressive, unresectable, or advanced melanoma who are considered to be candidates for systemic treatment with chemotherapy
* Subjects will have measurable disease, an Eastern Cooperative Oncology Group Performance Status less than or equal to 2, and serum LDH less than or equal to 1.1 times the upper limit of normal, but will not have previously received cytotoxic chemotherapy
* Prior immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy is permitted in the adjuvant and/or metastatic setting

Exclusion Criteria:

* Prior treatment with cytotoxic chemotherapy, including regional perfusion, or with Genasense®(oblimersen sodium)Injection
* Nonmeasurable disease only
* History or presence of brain metastasis or leptomeningeal disease
* Significant medical disease other than cancer
* Known human immunodeficiency virus infection
* Pregnant or lactating
* Known hypersensitivity to temozolomide, phosphorothioate-containing oligonucleotides, or products containing human albumin
* Use of any experimental therapy within 3 weeks prior to baseline evaluations, Other anticancer treatment (such as chemotherapy, radiation, or biologic or investigational therapies) while receiving therapy in this study
RF-assisted Splenic Preservation VS Conventional Treatment of Blunt Splenic Injury.

Radiofrequency (RF) can be used to treat splenic trauma because of its excellent coagulation hemostasis. This study aimed to compare the efficacy of RF-assisted spleen-preserving surgery with that of conventional splenorrhaphy/splenectomy in the treatment of blunt splenic injury.

A total of 122 patients with splenic trauma admitted to two tertiary referral centers from June 2011 to June 2014 were included in this prospective cohort study. The 67 patients at one center were treated by radiofrequency-assisted spleen-preserving therapy (RF group), and the 55 patients admitted at the other center underwent conventional treatment (CT group). Demographics and clinical characteristics of the two groups were comparable.

Compared to traditional splenorrhaphy and splenectomy, RF-assisted splenic hemostasis and salvage was safe, effective and easy to use in the treatment of splenic injuries. In particular for high-grade splenic injuries, these techniques preserved sufficient splenic tissue without any increase in patients with surgical risk.


Eligibility Criteria:
Inclusion Criteria：

1. age below 70
2. blunt abdominal injury combined with indication of post-traumatic splenectomy according to the guidelines provided by the Society for Surgery of the Alimentary Tract in 2005
3. patients transferred directly to the trauma center after injury who had not been treated by any specific spleen-directed therapy in the transferring hospital
4. AAST grade II splenic injury with hemodynamic instability or progressive bleeding requiring active intervention
5. AAST grade Ⅲ-Ⅳsplenic injury, or splenic laceration involving less than 50% of the splenic parenchyma

Exclusion Criteria:

1. penetrating abdominal injury
2. concomitant organ injury with an abbreviated injury scale (AIS) greater than 4 that threatened the life of the patient
3. excessive vascular injury to the splenic pedicle or substantial devitalized splenic tissues when it was expected in when less than 25% of the spleen could be preserved
4. patients who had failed NOM
5. patients with pathologic splenic rupture
Chidamide Combined With Clad/Gem/Bu With AutoSCT in High Risk Hodgkin & Non-Hodgkin Lymphoma

This study is to explore the efficacy and safety of ChiCGB conditioning therapy in patients with high-risk Hodgkin and non-Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary refractory or recurrent diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T cell lymphomas, Hodgkin lymphomas that do not qualify for treatment protocols of higher priority.
* Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.
* Adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL.
* Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal.
* Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) \>/= 50% of expected corrected for hemoglobin.
* Adequate cardiac function with left ventricular ejection fraction \>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
* Performance status 0-1. 10. Negative Beta diffusing capacity of the lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria:

* Central nervous system lymphoma
* Patients relapsed after autologous stem cell transplantation
* Bone marrow was involved by lymphoma
* Patients with active hepatitis B or C(HBV DNA \>/=10,000 copies/mL).
* Active infection requiring parenteral antibiotics
* HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (CD4) counts
* Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
* Patients with a corrected QT interval(QTc) longer than 500 ms
Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods

Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac magnetic resonance imaging (CMRI)

20 healthy volounteers between age of 20-40 years, no previous medical history undergo simoultaneous left ventrikular strokevolume measurements using three different methods at rest. After datasampling and without moving, the subject then undergo Cardiac Magnetic Resonance Imaging with 2D-throughplane and cine tecnology for validation of volume measurements. The data is then analyzed using Bland-Altman calculation.

Eligibility Criteria:
Inclusion Criteria:Healthy volounteers age 20-40, BMI \< 30, weight \< 100 kg, no medications, sinus rythm on ECG, no contra-indications for MRI, ability to give written informed consent.

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Exclusion Criteria:

* Heart and/or vascular disease such as angina pectoris, arrythmias, claudicatio intermittens e g.
* Diseases in gastrointestinal tract or nose.
* Coagulopathies
* Pregnancy
* Allergys for local anaesthetics
* Claustrofobia
Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 FTC

This study aims to thoroughly examine survival disparities in patients with T3 or T4 stage follicular thyroid carcinoma (FTC) as classified by the AJCC staging system. It compares outcomes between those who underwent total thyroidectomy (TT) and those who did not, and assesses the influence of radioactive iodine therapy (RAIT) on the survival of patients without TT. Utilizing the SEER database, a retrospective study identified patients diagnosed with T3 or T4 FTC, categorizing them into two cohorts: those treated with TT and those who were not (No-TT). The No-TT group was further analyzed to determine the impact of RAIT on patient survival. Propensity score matching (PSM) was applied to adjust for confounding variables. Survival analysis, including Kaplan-Meier survival curves and Landmark analysis, was conducted to evaluate the effects of surgical intervention and RAIT on overall survival (OS) and cancer-specific survival (CSS).


Eligibility Criteria:
Inclusion Criteria:1.The primary site code C73.9, denoting the thyroid gland;2.The International Classification of Diseases for Oncology, Third Edition (ICD-O-3) histology types comprising 8330 (Follicular adenocarcinoma, NOS), 8331 (Follicular adenocarcinoma well differentiated), 8332 (Follicular adenocarcinoma trabecular), 8335 (Follicular carcinoma, minimally invasive), and 8339 (Follicular thyroid carcinoma (FTC), encapsulated angioinvasive).

Exclusion Criteria:(1). Absence of T stage information or designation as T1, T2; (2). Missing surgery codes; (3). Cases not verified by histopathological analysis; (4). FTC not being the initial malignancy diagnosed in the patient; (5). Unknown survival duration or survival less than one month; (6). Presence of bilateral tumors.
Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histologically proven gastric adenocarcinoma which is complete resected
* ECOG performance status of 1 or lower
* Adequate bone marrow function

  * absolute neutrophil count \[ANC\] ≥1,500µL, and platelets ≥100,000/µL
* Adequate kidney function (serum creatinine \< 1.5 mg/dL)
* Adequate liver function (serum total bilirubin \< 2 times the upper normal limit (UNL) serum transaminases levels \<2 times UNL
* No prior chemotherapy

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Evidence of distant metastasis
* Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
* Uncontrolled infection
* Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry
* History of significant neurologic or psychiatric disorders including dementia or seizures
* Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
* Symptoms of gastrointestinal obstruction
* concomitant drug medication: The following drugs cause drug interaction with S-1.
Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations

Neuromas are a common complication after digital and hand amputations, resulting in significant pain, discomfort, and functional impairment. Various management methods are available, including surgical excision, nerve blocks, and nerve stump protectors, but these treatments may have limited success rates and potential complications. Targeted muscle reinnervation (TMR) is a promising technique that involves surgically rerouting a severed nerve into a nearby muscle, which can prevent the formation of neuromas and provide improved muscle function


Eligibility Criteria:
Inclusion Criteria:

* Arabic or English speaking individuals
* An upper limb amputation distal to the wrist crease
* A symptomatic neuroma within the hand or digits: defined as patient-reported localized pain consistent with a clinical exam of a neuroma pain.There must be a supporting Tinel's sign on physical exam.

Exclusion Criteria:

* Cognitive impairment for better assessment of patient reported outcomes and filling questionnaires and signing consents
The Effect of Time on Generalization of Exposure-based Benefit

Participants will receive a pre-assessment and an exposure with a control spider. This control spider will be presented again at post-training assessments. Participants will then be assigned to one of the follow-up assessments: one week, six weeks or three months. The control spider (spider A) and a novel spider (spider B) will be used again at follow-up BATs to test for generalization of exposure effects.

Several findings from basic research on extinction learning undermine the role of time effects in the contextualization and retrieval of extinguished memories (Archbold et al., 2013; Quirk, 2002; Wiltgen \& Silva, 2007). The latter bears important implications for the evaluation of short- and long-term effects of exposure-based fear reduction and generalization. To date, no study exists examining the role of time on the fear responding to treated stimuli and/or untreated stimuli after successful exposure. It will be investigated whether the differential responding to treated and untreated stimuli after exposure is dependent on the passage of time.

Spider fearful participants will be subjected to a standardized one-session treatment with spiders serving as treatment stimuli. Fear reduction towards treatment stimuli will be assessed at post-treatment. Furthermore, generalization of exposure therapy towards untreated stimuli (i.e., a novel spider) will be assessed. The extent of generalization of exposure-based fear reduction to untreated stimuli will be compared between three groups that will differ with respect to the follow-up length. Here, participants undergoing exposure will be randomly assigned to one of the following follow-up measurements: one week follow-up, six weeks follow-up, and three months follow-up. The extent of exposure induced fear reduction and generalization will be assessed and compared between these groups.

Eligibility Criteria:
Inclusion Criteria:

* Presence of fear of spiders (Potential diagnosis of arachnophobia)

Exclusion Criteria:

* Reaching level 10 or higher in the initial (Pre-Exposure) Spider BAT
* Any acute or chronic mental and / or somatic disease
* Psychological, psychiatric, neurological or pharmacological treatment
* Drug or alcohol abuse
* Pregnancy
A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old at the screening visit (Visit 1)
* Has a diagnosis of FECD at Visit 1
* Meets all other inclusion criteria outlined in clinical study protocol

Exclusion Criteria:

* Is a female patient of childbearing potential and any of the following is true:

  1. is pregnant or lactating/breastfeeding, or
  2. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
* Has a study eye with a history of cataract surgery within 90 days of Visit 1
* Meet any other exclusion criteria outlined in clinical study protocol
Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder

Biochemotherapy (combined immunotherapeutic drugs and chemotherapeutic drugs) has shown virtue than that use chemical or biological drugs alone in the treatment of some malignant tumor. Here we investigated the efficacy of sequential intravesical therapy with EPI and BCG to EPI or BCG alone in patients with transitional cell carcinoma of bladder cancer after surgical management.

Methods From July 1996 to November 2003, a total of 138 cases of bladder cancer underwent TURBT or partial cystectomy were entered the trail. They were divided into 3 groups randomly: 1, EPI plus BCG; 2, use BCG alone; and 3, use EPI alone. All the patients have been followed up for 28-40 months after surgery (average time was 36 months), and the frequency of bacterial, chemical cystitis and other local side effects were also observed.Results After a median follow up of 36 months, the number of recurrences in group 1 was significantly reduced than group 2 and 3 (p\<0.05 vs group 2 and 3, x2-test). The frequency of bacterial, chemical cystitis and other local side effects was similar in group 1 and 2, whereas significant severe side effect was found in group 3 (p\<0.05 vs group 2 and 1, x2-test). Allergic reactions, including skin rash, were more frequent in group 3, and other systemic effects were more frequent in group 1. Conclusion Biochemotherapy by single dose EPI plus sequential BCG intravesical is markedly effect in preventing the recurrence of bladder cancer after surgical management. Its side effects are low. This method is of high clinical value.

Eligibility Criteria:
Inclusion Criteria:

* primary single or multiple (more than 2 tumors) pTa to pT1 transitional cell carcinoma, solitary or multiple grade Ⅲ tumors and primary or concomitant carcinoma in situ of the bladder were included in the study

Exclusion Criteria:

* Previous radiotherapy, intravesicial or systemic chemotherapy within 3 months of the study, presence of a second primary malignancy and transitional cell carcinoma of the upper urinary tract or prostatic urethra, invasion of periurethral prostatic ducts, prostatic gland or stroma were exclusion criteria
Cup Versus Bottle Feeding for Late Preterm Infants

The purpose of the current study is to investigate the effect of using cup feeding for preterm infants during NICU stay on breastfeeding outcomes after discharge. The following hypotheses are being tested:

1. Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle
2. Infants fed by cup during NICU stay will have higher breastfeeding behaviour score on the Preterm Infant Breastfeeding Behavior Scale than infants fed by bottle

The provision of breast milk is essential for preterm infants as it provides unique health benefits that are unmatched by other types of feeding \[1-3\]. However, breastfeeding presents unique challenges for preterm infants that include establishing and maintaining the mothers' milk supply and transitioning the infant from gavage feeding to breastfeeding \[4\]. One of the issues that presents during the transition to breastfeeding is that mothers of preterm infants are rarely available for all oral feedings during hospitalization; this makes it necessary for infants to receive oral feedings by other method, usually bottle feeding.

However, exposure of newborn infants to artificial nipples has been strongly associated with breastfeeding problems \[5-9\]. Frequently these problems have been explained by phenomena called nipple confusion. Nipple confusion occurs when infants are exposed to two different feeding methods, bottle and breast, resulting in the infant refusing to breastfeed. Consequently, it has been recommended that bottle feeding be avoided and that cup feeding be used for the supplementation of term as well as preterm infants.

Cup feeding is known as an alternative method of feeding breast milk to an infant using a small cup without a lip. Cup feeding is also recommended by the Baby Friendly Hospital Initiative.The use of cup was originally based on the goal of avoiding propping of bottles and also to increase bodily contact with the mother during feeding. Although cup feeding receives little mention in medical literature, and may seem to be a new technique for some, it has been used in several developing as well as developed countries. Lang, who observed cup feeding in South Nepal, implemented cup feeding in England and the practice expanded to other developed countries. Consequently cup feeding was established as a method for feeding infants who could not be breastfed from birth.

Eligibility Criteria:
Inclusion Criteria:

* Singleton birth
* 34 to 37 weeks of gestation at birth
* Maternal intention to breastfeed
* Fed only by tube feeding

Exclusion Criteria:

* Infants who had any condition interfering with oral feeding
* Infants with craniofacial anomalies
* Infants with intracranial hemorrhage