cyrilzakka/clinical-trials huggingface dataset:
Omegaven Expanded Access Protocol

Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
* Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
* Failed standard/conventional therapies to prevent progression of PNALD.
* Age newborn to 17 years of age
* Signed informed consent.

Exclusion Criteria:

* Allergy to eggs and/or shellfish
* Female who is pregnant or lactating
* Severe hemorrhagic disorder
* Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
* 18 years of age or older
* Parent/legally authorized representative is unwilling to consent.
Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group A ) A Randomized Controlled Clinical Trial

20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)

* for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
* In the study group: implant will be inserted in the low speed osteotomy site. • In the control group: implants will be inserted in the conventional prepared osteotomy site.
* For both groups there is no surgical guide used.
* The flap will then be copiously irrigated with saline in preparation for closure.
* The flap will then be closed using interrupted 4/0 resorbable sutures.


Eligibility Criteria:
Inclusion Criteria:

* Patients restoring missing maxillary teeth with implant placement.
* Both sexes.
* Age: 25-45
* Mesio-distal dimensions: Not less than 6 mm
* Bone Height: Not less than 12 mm
* Bucco-lingual dimensions: Not less than 8mm
* All measures will be assessed using CBCT.

Exclusion Criteria:

* Sites needing bone grafting or augmentation.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
Negotiating a Quit Date or Not in Online Interventions

The primary purpose of the current study is to test the effect of providing users of automated web-based smoking cessation interventions with the option of negotiating and re-negotiating the quit date.

Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about how such interventions should be designed to increase their efficacy

The primary purpose of the current study is to test the effect of providing users of automated web-based smoking cessation interventions with the option of negotiating and re-negotiating the quit date.

The investigators propose a 2-arm RCT with 1500 adult study participants that all receive a best practices web-based smoking cessation program designed for use on smart phones (web-app). The intervention includes a ten day/session preparation phase (participants continue smoking) as well as a four week post-cessation follow-up phase (14 sessions). The post-cessation phase will only be given to participants that report an initial quit attempt. Participants will be randomized to two versions of the intervention: 1) A version that does not provide participants with the option of negotiating the quit day (the preparation phase is fixed to ten days/sessions); or 2) a version that provides the participants with the option of negotiating/re-negotiate the quit day on three occasions. The three occasions are on the first day/session of the intervention, on the fourth day/session of the intervention and on the eleventh day/session of the intervention. The primary outcome is making a quit attempt.

Eligibility Criteria:
Inclusion Criteria:

* 18 year or older
* being a current smoker
* determined to or considering to quit smoking
* provide valid e-mail address
* provide valid norwegian cell phone number
* complete a baseline questionnaire
* start using the intervention (pushing the next page button one time or more on the first session provided

Exclusion Criteria:

-
A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males

To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between 18-55 years of age
2. BMI of 17.5-30.5 kg/m2

Exclusion Criteria:

1. History of drug or alcohol abuse within 2 years of screening
2. Subjects without suitable veins for multiple venipuncture/cannulation
Least Invasive Nonlinear Light Microscopy

Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy


Eligibility Criteria:
Inclusion Criteria:

* Health volunteer
* Patient with suspected oral mucosa lesion

Exclusion Criteria:

* Active infectious disease
* Inability to cooperate
Carbidopa for the Treatment of Excessive Blood Pressure Variability

The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension and normalize or reduce the exaggerated blood pressure variability in patients with familial dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or Riley-Day syndrome). Funding Source- FDA OOPD.

The investigators propose to perform a double-blind randomized trial with a cross over design to compare high dose (600 mg/day) and low dose (300 mg per day) carbidopa blockade with placebo. Patients will be randomly assigned to a high-dose/low-dose/placebo sequence, lowdose/placebo/high-dose sequence or placebo/high-dose/low-dose sequence. Participants will remain on each treatment period for 28-days.

Aim 1: To evaluate the safety and tolerability of carbidopa in FD patients with particular emphasis on the orthostatic fall in blood pressure.

Aim 2: As proof of concept, examine the hemodynamic effects of carbidopa and determine its effects on norepinephrine production, BP variability and paroxysmal hypertension.

Aim 3: In a dose finding study, compare the effects of low (300 mg/day) and high (600 mg/day) dose carbidopa blockade vs. placebo on BP variability and paroxysmal hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with familial dysautonomia (FD) age 10 or older
* Unstable blood pressure, defined as:

  * Systolic BP standard deviation \>15 mmHg
  * Or coefficient of variation \>15%
  * Or documented episodic hypertensive peaks (\>140mmHg)
* Confirmed diagnosis of FD (genetic testing)
* Providing written informed consent (or ascent) to participate in the trial
* Ability to comply with the requirements of the study procedures.

Exclusion Criteria:

* Patients taking monoamine oxidase (MAO)-inhibitors
* Patients taking: metoclopramide, domperidone, risperidone or other dopamine blockers
* Patients taking tricyclic antidepressants
* Patients taking neuroleptic drugs (haloperidol and chlorpromazine)
* Patients with a known hypersensitivity to any component of this drug.
* Patients with atrial fibrillation, angina or significant ECG abnormality
* Patients with significant pulmonary, cardiac, liver, renal (creatinine \>2.0 mg/ml)
* Patients who have a significant abnormality on clinical examination that may, in the investigator's opinion might jeopardize their healthy participating in this trial.
* Women who are pregnant or lactating.
Study of Tissue Expansion Devices Complications

Reduce the common complications incidence about patients placed tissue expansion devices to around 5%.

Study design： Randomized parallel controlled trial. Study comments: 1.Telephone follow-up trainment group about 2-3 months until secondary hospital. 2.Promote the health management manual of patient placed expander,which includes discharge list, injection list, expander affusion operation procedure, injection myth, you ask me answer,injection record, injection diary record, appointment diaries etc.

Eligibility Criteria:
Inclusion Criteria:

* aged 1-70 years male and female;
* no complication when inclusion;
* sign the informed consent.

Exclusion Criteria:

* joined other clinical trial;
* occurred complications before inclusion;
* other infectious diseases;
* the pregnant or lactating women.
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial

This is a new inguinal hernia repair technique.

In this study we are revealing a new inguinal hernia repair technique. It is constructed from two layers. Deep layer is modified Shouldice technique, the other superficial one is moloney technique.

Eligibility Criteria:
Inclusion Criteria:

* Inguinal hernia

Exclusion Criteria:

* Recurrences, child
An Investigation of the Past 10 Yrs Health Care for Primary Care Patients With Chronic Obstructive Pulmonary Disease

The aim of this study is to describe COPD health care and to assess demographics, concurrent diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary disease (COPD) population in real life in primary care during the last ten years.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis according to medical records.
* Use of drugs prescribed for obstructive lung diseases
Phase 2B Extension Study of Ataluren (PTC124) in Duchenne/Becker Muscular Dystrophy (DMD/BMD)

Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, and other important clinical and laboratory measures.

This is a Phase 2b, international, multicenter, open-label extension study for participants who successfully completed blinded study drug in Study 007. This extension study will evaluate the long-term administration of ataluren administered 3 times per day (TID) at morning, midday, and evening doses of 20, 20, and 40 milligrams/kilogram (mg/kg), respectively, in participants with nonsense mutation Duchenne/Becker muscular dystrophy (nmDBMD).

Eligibility Criteria:
Inclusion Criteria:

* Completion of blinded study drug treatment in the previous Phase 2b study (PTC124-GD-007-DMD).
* Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if less than \[\<\]18 years of age).
* In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during PTC124 administration and the 6-week follow up period.
* Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.

Exclusion Criteria:

* Known hypersensitivity to any of the ingredients or excipients of the study drug (Litesse® UltraTM \[refined polydextrose\], polyethylene glycol 3350, Lutrol® micro F127 \[poloxamer 407\], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla, Cab-O-Sil® M5P \[colloidal silica\], magnesium stearate).
* Ongoing participation in any other therapeutic clinical trial.
* Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results.
Multimodal Exercise Effect on Brain Dynamics, Cognitive Functioning and Physical Fitness

The aim of present study is to analyze the effect of a multimodal exercise program on brain dynamics, cognitive functioning and physical fitness in community-dwelling older adults This experimental study is a controlled trial. Participants will be allocated to two groups: experimental group (who attend the multimodal exercise program) and control group (who maintain usual activity).

The multimodal exercise program will run for 12 weeks (3 sessions / week of 60 minutes).

Participants will be assessed 1) at baseline and at 2) at 12 weeks.

Aging is associated with a decline in cognitive functioning (CF), which influence negatively the motor capacities of older adults (1). Differences on dynamic brain, namely reductions in structural and functional connectivity contribute to cognitive decline. However, efficient communications between brain regions works like a prerequisite for CF (2,3).

Programs targeting cognitive functioning improvement evidenced the importance of the information processing speed (IPS). However, IPS may not be the only factor conditioning the relationship between CF and gait in the older people, especially in locomotive tasks that require attention (4). According to Lezak et al. (5), the performance in each area of CF decreases with aging, and the most significant decline is reported on the performance of complex attentional tasks such as selective or divided attention.

Recent studies focusing cognitive or physical fitness programs, have been shown that dual-task (DT) performance, particularly involving walking while performing a task with cognitive interference, predicts the risk of frailty, disability and mortality in older people (6,7).

According Bahureksa, et al. (8), for balance maintenance is needed to incorporate and decipher the sensorimotor information through CF. On the other hand, exercise programs reported as effective strategies for agility, muscle strength and body composition improvement (9, 10). However, no studies were found focusing the effect and benefits of a multimodal exercise program privileging IPS on brain electrical activity, CF and functional fitness in community-dwelling older adults.

This multimodal exercise program, privileging information processing speed and comprising sensorimotor and neurocognitive exercises, may revert the process of loss and decline on brain dynamics, CF and physical fitness in community-dwelling older adults.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged ≥65 years;
* Community-dwelling older adults living independently;

Exclusion Criteria:

* Presence of cognitive impairment (Mini-Mental State Examination) (11);
* Presence of motor impairment compromising the program participation;
* Presence of neurological problems or diseases compromising the program participation;
Laparoscopic Ultrasound Guided Tissue Sampling in Patients With Cancer of the Upper Gastrointestinal Tract

Laparoscopic Ultrasound (LUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When a suspect lesion is visualized during LUS a biopsy should be provided in order to differentiate between benign and malignant lesions. A new system for LUS guided biopsy has been developed, but how often these biopsies are clinically relevant (i.e. changing patient management)and how reliable are these biopsies are unknown.

The study hypothesis is that LUS guided biopsies are accurate and clinically relevant in the pre-treatment evaluation of patients with upper gastrointestinal tract cancer.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven upper GI tract cancer
* Laparoscopic Ultrasound indicated during pre-treatment evaluation

Exclusion Criteria:

* Patients unfit for surgery
The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients

SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SP2086 in Type 2 Diabetes Patients .


Eligibility Criteria:
Inclusion Criteria:

* The patient has a definitive diagnosis of Type 2 Diabetes.
* BMI(a measure of a person's weight in relation to height)is between 19 and 30 kg/m2,and the weight is equal or greater than 50kg.
* Never use the antidiabetic or only use one type oral antidiabetic(except the insulin secretagogues agent).
* The patient never use insulin in 3 months of screening.
* Be willing to accept physical contraception.
* Sign the informed consents voluntarily and ensure to completed the study.

Exclusion Criteria:

* The value of fasting blood-glucose(FBG)\>13.9mmol/L,or HbA1c\>10.0%;
* Known allergy to SP2086 or any of the excipients of the formulation of SP2086;
* Type 1 diabetes,or Gestational diabetes,or other type diabetes;
* ever occured acute complications of diabetes such as diabetic ketoacidosis,high permeability syndrome or lactic acidosis.
* ever occured the severe hypoglycemia.
* History of chronic complication of diabetes(kidney disease,or retinopathy,neuropathy,or lower limb vascular lesion).
* The value of serum creatinine over the upper limit of normal range.
* ever occured myocardial infarction,acute coronary syndrome, transient ischemic attack.
* QTc interval\>450ms(male) or \>470ms(female) or have the history of cardiac insufficiency which the NYHA(New York Heart Association) class over I degree.
* have the history of hypertension,and not well control:SBP(Systolic Blood Pressure)\>140 mmHg or DBP(Diastolic Blood Pressure)\>90 mmHg.
* have the history of cancer.
* the value of ALT and/or AST was greater two times of upper limit of normal range,or the STB over the 1.5 times of upper limit of normal range.
* the B hepatitis surface antigen or hepatitis C antibody or syphilis antibody or HIV antibody was positive.
* had participated three or more clinical trial in one year or had participated one time clinical medicine in one month of screening.
* have the history of blood donation in 3 months of screening or received the blood transfusion in 1 months of screening.
* have the history of tobacco,alcohol or drug abuse.
* History of or current clinically significant medical illness as determined by the Investigator.
Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation

Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to the effects of MPA on the gastrointestinal tract, patients often complain of GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to an alternative agent, typically Azathioprine. Both of these strategies have limitations, largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse effects, so the investigators will convert patients to EVR in this study. Patients who are within their first year post-transplant will be converted to EVR upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplant recipients at Washington University/Barnes-Jewish Hospital
2. Experiencing GI toxicity from MPA as determined by the treating physician within 12 months post-renal transplant
3. On standard immunosuppression with tacrolimus and prednisone

Exclusion Criteria:

1. Dual organ or kidney after another solid organ transplant
2. Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
3. Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
4. Estimated glomerular filtration rate (eGFR) \<40 ml/min at time of possible conversion
5. Proteinuria \>1 gram/day at time of possible conversion
6. Profound bone marrow suppression at the time of possible conversion as defined as:

   * Hemoglobin \<10 g/dL
   * White blood cell (WBC) \< 3 K/cumm
   * Platelets \<100 K/cumm
7. Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma)
8. Elevated total cholesterol (\>350 mg/dL) and/or triglycerides (\>500 ng/dL) at time of possible conversion
9. Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives
Is Video-assisted Thoracoscopic Lobectomy a Clinical Alternative for Surgically Resectable Pathologic N2 NSCLC Patients

The study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer

The is a multi-center retrospective study. Patients with pathologic N2 NSCLC who underwent VATS or open lobectomy between 2014 and 2017 were included into this study. Clinical data on patient demographic, clinical characteristics, treatment and clinical outcomes will be collected to evaluate the safety and effectiveness of video-assisted thoracoscopic lobectomy for pathologic N2 NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age \> 18 years old;
* Patients with pathologically diagnosed non-small cell lung cancer;
* Patients underwent lobectomy by either VATS or thoracotomy between 2014 and 2017;
* Patients who received lymphadenectomy for all accessible lymph nodes;
* Patients with N2 lymph nodes (+) after surgeries;

Exclusion Criteria:

* Patients with second primary tumors or multiple primary tumors;
* Patients who received chest surgeries before hospitalization;
* Patients with superior pulmonary sulcus tumor