cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD

This study will evaluate the use of a medical food, oral serum-derived bovine immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a wasting syndrome) improve their nutritional status and gain weight. The medical food is in powder form and is mixed with a liquid such as water or orange juice and consumed by swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the nutritional status of cachexic patients with advanced stages of COPD.


Eligibility Criteria:
Inclusion Criteria:

* Age between age 30 and 80 at Baseline Visit
* Diagnosed with 2012 spirometric COPD GOLD Stage 3 (FEV1/FVC ratio \<0.70, FEV1 30-49% of normal) or GOLD Stage 4 (FEV1/FVC \<0.70, FEV1 \<30% of normal or FEV1\<50% of normal with chronic respiratory failure present)
* Able to tolerate and willing to undergo study procedures
* Body Mass Index below 21
* Signed Informed Consent

Exclusion Criteria:

* History of comorbid condition severe enough to significantly impact 6 months outcomes
* Current substance abuse, including tobacco, alcohol and illicit drugs
* Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
* Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
* Active pulmonary infection with tuberculosis
* Non-COPD obstructive lung disease (various bronchiolitides, sarcoidosis, LAM, histiocytosis X) or parenchymal lung disease, pulmonary vascular disease, pleural disease, severe kyphoscoliosis, neuromuscular weakness, or other cardiovascular and pulmonary disease, that limit the interpretability of the pulmonary function measures
* Prior significant difficulties with pulmonary function testing
* Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers, or to beef
* History of lung or other organ transplant
* Currently taking \>20mg of prednisone or equivalent systemic corticosteroid
* Currently taking any immunosuppressive agent
* History of lung cancer or any cancer that spread to multiple locations in the body
* Known HIV/AIDS infection
* History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
* Current or planned pregnancy within the study course.
* Currently institutionalized (e.g., prisons, long-term care facilities)
A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms

The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).


Eligibility Criteria:
Inclusion Criteria:

* Participant has been diagnosed with IS within 6 weeks prior to Screening. Diagnostic criteria include both clinical spasms and an EEG pattern consistent with hypsarrhythmia or significant abnormality compatible with IS
* Participant has normal renal function as defined by an estimated glomerular filtration rate (eGFR) greater than \[\>\] 60 milliliter/minute (mL/min)/1.73 m\^2, calculated as eGFR = 0.413 × (height \[Centimeter (cm)\]/serum creatinine \[milligrams per deciliter {mg/dL}\])
* Participant's legally authorized representative (that is \[i.e.\], parent or guardian) must provide written informed consent obtained per Institutional Review Board (IRB) policy and requirements, consistent with the International Council for Harmonisation (ICH)
* Participant's parent/guardian is able to understand and willing to comply with study procedures and restrictions

Exclusion Criteria:

* Participant has been diagnosed with tuberous sclerosis
* Participant has acute illness considered clinically significant by the Investigator within 30 days prior to Screening
* Participant has a diagnosis of recent systemic fungal infection; history of ocular herpes simplex; history of or current peptic ulcer; uncontrolled hypertension or congestive heart failure; or any other condition that would be significantly impacted by the study drug
* Participant has a preplanned surgery or procedure(s) that would interfere with the conduct of the study
* Participant has received any prior treatment for IS
* Participant has been previously treated with adrenocorticotropic hormone (ACTH), corticosteroids, or Vigabatrin for seizures;
* Participant has been previously treated with a course of corticosteroids for an indication other than seizures within 30 days prior to Screening
* Participant has a known or suspected allergy to ACTH or Vigabatrin or any component of AMZ002 or Vigabatrin
* Participant has used any other investigational drug within 30 days or 5 half-lives prior to the first dose of AMZ002 or Vigabatrin (whichever is longer)
* Participant' s parent/guardian is unable to provide written informed consent and/or to complete the daily diary
* Participant has any other disease, condition, or therapy that, in the opinion of the Investigator, might compromise safety or compliance, preclude the participant from successfully completing the study, or interfere with the interpretation of the results
Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 19 to 70 years
2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia
3. Written informed consent

Exclusion Criteria:

1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
2. Uncontrollable diabetes with HbA1c ≥ 8.5%
3. Fasting LDL-C ≤ 70 mg/dL
4. Fasting triglyceride ≥ 400 mg/dL
5. Total cholesterol ≥ 300 mg/dL
6. History of muscular disease or rhabdomyolysis due to use of statin
7. Hypersensitive to rosuvastatin or ezetemibe
8. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:

   ① Severe renal disease (estimated GFR(MDRD) \< 30mL/min/1.73m2)

   ② ALT, AST \> 3x ULN or history of active liver disease

   ③ CPK \> 3x ULN
9. Administration of other investigational products within 30 days prior to screening visit
10. Other than the above who is deemed to be ineligible to participate in the trial by investigator
Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?

Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. The pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive hypoglycemia prevented.


Eligibility Criteria:
Inclusion Criteria:

* RYGB operated patients more than 12 month after operation
* Stable in weight for at least 3 months (+/- 3 kg)
* Plasma glucose below 3.4 mmol/L after screening with test meal (Fresubin drink) or with continuous glucose monitoring

Exclusion Criteria:

* Fasting plasma glucose concentration \> 7mmol/L
* Critical illness
* Hgb \< 6.5 mM
* Pregnancy or breastfeeding
Ciprofloxacin in Drug-resistant Epilepsy

This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Drug-resistant epilepsy with frequency of at least 2 seizure/Week
* Acceptance of patients or his/her guardian (Signing informed consent)

Exclusion Criteria:

* Hypersensitivity to ciprofloxacin or other fluoroquinolones
* History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis
* Usage of medications with interaction to ciprofloxacin
* No reliable contraception
* Pregnancy or breastfeeding
* Being under treatment with corticosteroid
* Usage of antibiotics in recent 2 months or need to use it during the study
* Patients who are candidate for epilepsy surgery or other nonmedical treatments
* Change in anti-seizure medications (ASMs) during recent month
* Patients who will need changes in ASMs dose during study
Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe pain attributed to knee osteoarthritis

Exclusion Criteria:

* Significant comorbidity
* Significant pain states other than osteoarthritis
* Concomitant medications that might affect assessments
Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder

The objective of this protocol is to establish a comprehensive screening process for the evaluation of eligibility for entry in a clinical trial program for children and adolescents with bipolar disorder.

To address the urgent therapeutic needs of children and adolescents ages 4-17 with pediatric bipolar disorder, we have designed a series of clinical trials aimed at evaluating critical components of the treatment needs of this under-served and under-researched population. This approach will allow us to provide a full complement of clinical trials that will meet the most pressing needs of the bipolar children and adolescents and their families who are currently awaiting treatment.

Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs makes it very difficult to ask subjects to sign a specific clinical protocol without obtaining additional clinical information. Because of this we are proposing potential subjects to consent to undergo an in-depth clinical assessment that will allow subjects to be screened by a clinician for eligibility to a diverse clinical trials program available to them.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar disorder.
* Subject and parent/ legal guardian must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their parent/ legal representative must be considered reliable.
* Each subject and his/her parent or authorized legal representative must understand the nature of the study. The subject's parent or authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
* One parent/ legal guardian must be able to accompany the subject to the clinic at each visit.

Exclusion Criteria:

* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
* Mental retardation
Effectiveness of Anti-Psychotic in GPs Setting

Evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on Quality of Life of GP-based management of antipsychotic treatment in Belgium


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)
Therapy for Depressed Elders With Thought Problems

This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive Therapy in treating elderly patients with major depression and thought problems.

Patients who suffer from a combination of major depression and executive dysfunction symptoms often respond poorly to treatment with antidepressants. It is important, therefore, to find effective alternative therapies to treat these symptoms.

Patients are randomly assigned to receive 12 sessions (1 session/week for 12 weeks) of either PST or BST. Following treatment, patients are followed for 6 months to determine functional and clinical outcomes. Depression scales, disability scales, and scales that measure problem solving skills are used to assess patients.

Eligibility Criteria:
Inclusion Criteria:

* Nonpsychotic, unipolar major depression
* Cognitive impairment
* English speaking

Exclusion Criteria:

* High suicide risk
* Dementia
* Acute or severe medical illness
* Current psychotherapy
A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer

The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.


Eligibility Criteria:
Inclusion Criteria:

* confirmed pathological esophageal squamous cell carcinoma
* ≥18 years old
* the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* no previous anti-tumor treatment
* no esophageal bleeding or fistula
* adequate hemocyte count, normal hepatic and renal functions
* Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score

Exclusion Criteria:

* lactating or pregnant women
* known hypersensitivity or allergy to any kind green tea extract
* placement of small intestinal feeding tube or endoscopic stent treatment
* unable or refusing to take oral liquids
Assessing the Utility of MMPI-2-RF-EX in Detecting Simulated Underreporting of Current Suicide Risk in Military Veterans

The aim of the current project are is examine the incremental predictive utility of the MMPI-2-RF-EX validity scales in detecting simulated underreporting of suicide risk on the MMPI-2-RF-EX and other self-report measures of suicide risk in 150 military Veterans experiencing past-month death or suicidal ideation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* US military veteran
* death or suicidal ideation/suicide attempt within the past month

Exclusion Criteria:

* non-Veteran status
* acute intoxication or active psychosis precluding provision of informed consent
* an inability to communicate and comprehend English
* residence outside the United States
* lack of past-month death/suicide ideation or attempt
* younger than 18 years of age
A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients

The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
* In addition, subjects must have normal pulmonary function tests and normal ocular examination.
* Body Mass Index (BMI) of 25.5 - 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Women must be of non-childbearing potential.
* Subjects with type 2 diabetes: HbA1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5% and ≤9.0% if patient requires to be washed-off an SU or DPP-4i.
* For subjects with type 2 diabetes, due to possible effects on disposition, CYP P450 3A4/5 and 2D6 substrates should not be co-administered with study medications.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic seasonal allergies at time of dosing).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products within 3 months of Screening, or positive cotinine test at Screening or Day -3.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Procalcitonin Protocol Use to Guide Antibiotic Therapy Duration in the Intensive Care Unit

To compare and contrast antibiotic use and its effects on patient outcomes before and after the implementation of a PCT protocol in the ICU at Methodist Richardson Medical Center (MRMC).

Based on previous clinical trials, current literature supports the use of PCT levels in combination with clinical assessments to help determine optimal antibiotic therapy. On May 30, 2022, MRMC launched a PCT protocol in the ICU that allows clinical pharmacy specialists to order PCT levels in certain bacterial infections. In order to determine the effects of the protocol, a retrospective quasi-experimental review will be conducted

Eligibility Criteria:
Inclusion Criteria:

* ● Patients aged 18 years or older

  * Patients being monitored on the PCT protocol
  * ICU location status for at least part of the admission
  * Received antibiotics in the ICU for a diagnosis of:

    * Community-acquired pneumonia
    * Hospital-acquired pneumonia
    * Ventilator-associated pneumonia
    * Sepsis and/or septic shock
    * Uncomplicated bacteremia with known source
    * Chronic obstructive pulmonary disorder exacerbation
    * Asthma exacerbation

Exclusion Criteria:

* Received antibiotics in the ICU for a diagnosis of:

  * Uncomplicated skin and soft tissue infections
  * Abscess
  * Empyema
  * Bacterial infections that require prolonged antibiotic therapy (e.g., osteomyelitis, endocarditis, tuberculosis, etc.)
  * Intra-abdominal infection
  * Urinary tract infection
  * Bacterial meningitis

    * Estimated Glomerular Filtration Rate \<15 mL/min
    * Requiring renal replacement therapy
    * Status post cardiac arrest/target temperature management
Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

Previous research into metabolic and hypoxic markers has found evidence of preclinical impact of exercise on prostate tumor blood flow and oxygenation in rodents . As radiotherapy is a frequently used and effective therapy for and that sufficient oxygenation is decisive to the effect of radiotherapy, an underlying hypothesis that aerobic exercise might improve treatment efficacy of radiotherapy in prostate cancer is put forward. This study has a potential challenging intervention, but a potential very high gain as it includes active patient participation to significantly improve outcome of radical radiotherapy.

A randomized controlled trial with four to five weeks of moderate/high intensity aerobic exercise program compared with no intervention for 32 prostate cancer patients waiting for radical prostatectomy at the University Hospital of North Norway (UNN). 16 patients will undergo the intervention. The expression of the hypoxic marker pimonidazole in the prostate specimens of intervention groups and the control groups will be assessed. This method is considered a reliable tissue oxygenation measurement technique. These patients will also have their and blood flow and hypoxia measured in prostate cancers through magnetic resonance imaging (MRIs).

Eligibility Criteria:
Inclusion Criteria:

* diagnosed PC
* planned radical prostatectomy
* informed consent given
* above 18 years of age
* BMI \< 30
* non-smoker
* living in Tromso region

Exclusion Criteria:

* Contraindications to the intervention like;

  * heart failure,
  * angina pectoris,
  * respiratory disease limiting possible intervention
  * use of physical supportive devices to aid movement
* High level of physical activity
* smoking
* BMI\>30
Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences (OPERA)

This cluster-randomised controlled trial will test the hypothesis that a multifaceted program with psychological intervention in morbidity mortality conferences (MMC) improve care quality and reduce the rate of morbidity mortality perinatal in diverse obstetric care settings.


Eligibility Criteria:
Inclusion Criteria:

* all newborns born between 1er october 2008 and 30 November 2010 (minimum : 22 weeks of gestation)

Exclusion Criteria:

* newborns died in context of abortion