cyrilzakka/clinical-trials huggingface dataset:
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women

This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in healthy lactating women. The objectives are to determine whether pregabalin is secreted in breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other objectives are to estimate potential infant exposure to pregabalin if administered to lactating women and to characterize the safety and tolerability of pregabalin in lactating women.

Post approval commitment for the FDA

Eligibility Criteria:
Inclusion Criteria:

* Healthy lactating females between the ages of 18 and 45 years (inclusive) who are actively breast-feeding or expressing breast milk and are at least 12 weeks post partum.
* Subjects must be willing to temporarily discontinue breast feeding their infants before the Day 1 evening dose through to 42 hours after the last dose

Exclusion Criteria:

* History of significant adverse reaction to pregabalin or gabapentin.
* Subjects pregnant or unwilling or unable to comply with the Lifestyle guidelines presented in the protocol during the study period and through the follow-up visit.
* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including post natal depression), neurologic or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing).
Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy.

The study hypothesis is that patients who under go cutting the filum terminale - the string-like lower end of the spinal cord - will have improved bladder function at 6-month follow up.

Bladder function and its effects on quality of life will be measured before surgery and at 6-month follow up.


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary daytime urinary incontinence, persistent over at least 6 months of medical treatment.
* Abnormal urodynamic testing
* Normal conus on magnetic resonance imaging of the spine
* Dysfunctional Voiding Symptom Scale score greater than 6 for girls or greater than 9 for boys

Exclusion Criteria:

* Bladder outlet obstruction
* Bladder atony
* Congenital anorectal malformation
* Additional diagnoses independently associated with neurogenic bladder dysfunction
* Encephalopathy precluding reasonable expectation of attainment of continence
* Inability to comply with medical management
* Unwillingness to comply with initial or follow up urodynamic testing
Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

This study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients


Eligibility Criteria:
Inclusion Criteria:

* pulmonary tuberculosis patients of age 18 years or above
* registered under Directly Observed Treatment Short course (DOTS) at Ojha Institute of Chest Diseases
* reported to have smoked 100 plus cigarettes in past and currently smoking cigarettes

Exclusion Criteria:

* Extra pulmonary tuberculosis
* drug resistant tuberculosis
* pregnancy
* positive history of epilepsy
HepQuant to Predict Hepatic Encephalopathy After TIPS

A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over the age of 18 able to provide consent
* Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites

Exclusion Criteria:

* Prisoners
* Pregnant women
* Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
* Subjects taking beta-blocker medications or angiotensin converting enzyme inhibitors
* Subjects with evidence of porto-systemic shunts present on imaging (eg splenorenal shunt)
* Subjects with calculated MELD score \>12 based on most recent laboratory values before consent
* Subjects with prior history of overt hepatic encephalopathy (grade 3-4) that was primary reason for hospitalization. Episodes of hepatic encephalopathy that were the consequence of other precipitating event (such as variceal bleeding or infection) will not be considered exclusionary.
* Subjects with a known sensitivity to albumin preparations, any ingredient in the formulation, or components of the container
* Subjects unable to fast for \>5 hours prior to the HepQuant administration or subjects who are unable to drink the oral dose of the cholate (\~40mL of liquid).
Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain

The public health relevance of this proposed project is substantial given the current opioid abuse epidemic as identified by the Centers for Disease Control (CDC). This study finalizes and tests a new psychotherapy treatment that is designed to treat chronic pain and opioid addiction at the same time in a format that could be easily used in a community addiction treatment setting. Final products of the study will yield an integrated STOP (Self-regulation/Cognitive-behavioral therapy (CBT) Therapy for Opioid addiction and Pain) manual guided protocol, patient workbook, and therapist training protocol.


Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old;
2. Willing to adhere to study protocol including treatment sessions and assessments;
3. Individuals have a history of co-morbid opioid use disorder and chronic pain;
4. Cognitively able to participate and give informed consent.

Exclusion Criteria:

1. Acute or unstable psychotic disorder;
2. Psychiatric hospitalization or suicide attempt in the past 3 months
3. Patient has been diagnosed with an unstable cardiovascular condition including: myocardial infarction, arrhythmia, or poorly controlled hypertension in the past 3 months
4. Lack of verbal and written English fluency
5. Over the age of 65 since evidence suggests pain perception alters with age
Early Functional Training in Acute Stroke Inpatient Ward

To investigate the difference between two models of an early intervention program (focused on mobility function) in the functional recovery 3 months post stroke in a group of patients with acute ischemic stroke while in acute inpatient ward hospitalization.

Patients with acute stroke admit into an acute inpatient ward who meet study criteria and provide institutional-reviewed consent form will be randomly assigned into either model 1 or model 2 of an early functional training program. Participants in model 1 group will receive 2 sessions of functional training per day whereas those in model 2 group will receive 1 session of functional training and 1 session of friendly visit and education per day. The following outcomes will be measured at admission, at discharge and at 3 months post stroke: Barthel index (BI), Postural Assessment Scale for Stroke (PASS), Mobility Scale for Acute Stroke (MASA), and usual gait speed (UGS). The rater is blinded to participants' group membership.

Eligibility Criteria:
Inclusion Criteria:

* patient with acute ischemic stroke / ICH
* referred for early rehabilitation,
* aged 20 years or more,

Exclusion Criteria:

* able to walk independently and safely at admission,
* unable to understand three simple comments,
* unable to recovery even with appropriate medical management,
* serious condition require ICU care,
* terminal illness for hospice care,
* waiting to transfer to long term care facilities
Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer

This is an observational, post-authorization, prospective follow-up, multi-centre, national study designed to describe the spectrum of health-related quality of life in patients with metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to treat patients will be performed prior to the decision to include the patient in the study.

Given the observational nature of the study, follow-up of patients will be performed according to standard clinical practice of each site.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years.
* Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically
* Patients with Karnofsky index ≥ 70 previously untreated with chemotherapy.
* Patients with life expectancy ≥ 6 months.
* Patients who will be treated with chemotherapy as first-line treatment for metastatic pancreatic cancer.\*
* Informed consent in writing or orally before witnesses.

  * The decision to prescribe any treatment will be clearly dissociated from the patient's inclusion in the study. Therefore, the choice of therapeutic strategy will be made according to usual clinical practice and independently by the doctor before assessing the possible involvement of the patients in the study and their corresponding inclusion in it

Exclusion Criteria:

* Pregnant or breastfeeding.
* Patients who are participating in an interventional clinical trial.
* Patients who refuse to participate in this study.
* Patients who have no ability to understand and respond to questions related to their health.
Non-invasive Determination of Anemia in Children With Renal Failure

Anemia and inflammation are very common in patients with renal diseases. The most common procedure to detect anemia is to determine blood hemoglobin concentrations. The Haemospect® is a portable device for non-invasive hemoglobin determination that works with a sensor that is applicable in infants and adults alike.

The objective of this trial is to collect spectra with the non-invasive Haemospect® device in children of different age groups with renal failure and different hemoglobin concentrations. In parallel, corresponding hemoglobin values shall be obtained invasively to form the basis for the development of an algorithm for the device.

To determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are measured non-invasively with the Haemospect®. Various blood parameters for iron and inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron, white blood cell count and CRP.


Eligibility Criteria:
Inclusion Criteria:

* all children in treatment for renal insufficiency in FUNDANIER

Exclusion Criteria:

* none
Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available
* Tumor expression of Lewis Y antigen ( \> or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
* Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to the first dose of CMD-193.
* Significant prior allergic reaction to recombinant human or murine proteins
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients

The primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV), 2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* chronic (\> 3 months) hemodialysis population of \> 18 years old
* PTH \> 300 ng/L
* corrected Ca \> 2.10 mmol/L
* stable hypertensive drugs (\> 1 month)
* stable doses of phosphate binders and dialysis calcium concentration
* palpable femoral pulse
* systolic BP of 90-180 mmHg
* expected survival of \> 6 months

Exclusion Criteria:

* hemodialysis \> 3 years
* acute infection
* history of myocardial infarction or stroke within the past 3 months
* inability to consent
* intolerance to cinacalcet
* inadequate birth control
Telehealth Postop Follow up RCT

A randomized controlled trial that will evaluate whether telephone two-week postoperative follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic two-week postoperative visits.

This is a two group, parallel randomized non-inferiority clinical trial at one institution evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient preference, and patient safety, when compared with clinic postoperative visits. This protocol was written in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines 2011.

Eligibility Criteria:
Inclusion Criteria:

* Women \>18 desiring surgical management of prolapse or incontinence
* English speaking
* Willing and able to provide written and informed consent without assistance from medical surrogate or interpreter
* Immediate access to telephone services (landline, mobile phone, office phone)

Exclusion Criteria:

* Women \<18
* Non-English speaking
* Unwilling and unable to provide written and informed consent without assistance from surrogate or interpreter
* Hearing impairment
* No access to telephone services (landline, mobile phone, office phone)
* Grade 3 complication- a complication requiring surgical, endoscopic, or radiological intervention. \[3\]
* Patient who did not attend any postoperative follow up visit
LED Therapy for the Treatment of Concussive Brain Injury

A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo therapy (controls) or treatment with LED therapy (cases). Both cases and controls would complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms resolve before the end of the 6 week period.

Concussion, also known as mild traumatic brain injury (mTBI), results from a rotational acceleration of the brain. The biomechanical forces which cause concussion lead to the opening of ion channels within the neuronal cell membranes, allowing for a massive influx of sodium and efflux of potassium. This results in a spreading depression type of phenomenon, leading to the depolarization of neurons diffusely throughout the brain.19 In order to restore the homeostatic ion gradients across the membrane, the sodium-potassium pumps require increasing amounts of adenosine triphosphate (ATP). Thus, there is an increased need for ATP after concussion. ATP is supplied by the glycolysis of glucose from the blood stream. Both experimental models of concussion and human studies, however, show decreased cerebral blood flow after the initial response to injury. Thus, there is an increased demand for ATP after concussion; but a diminished supply of glucose to meet the demand.

The absorption of light in the red/near infrared wavelength spectrum by cytochrome C oxidase increases ATP synthesis. Thus, by increasing ATP synthesis, red/near infrared LEDs can treat the underlying pathophysiological cause of concussion symptoms. If successful, this would be the first therapy to directly treat the underlying pathophysiology of concussion.

Eligibility Criteria:
Inclusion Criteria:

* Patients 11 years old or greater
* Diagnosed with a concussion whose symptoms have persisted for more than 4 weeks
* Total score on the cognitive components of the post-concussion symptom scale exceeds 9, or if they have a composite score on any one of the 4 main outputs of the computerized neurocognitive assessment: Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) that is below the 90th percentile for their age.

Exclusion Criteria:

* Clinically indicated imaging has been obtained where a hemorrhage is demonstrated
* Being considered for an alternate diagnosis (other than concussion)
* Have a pre-injury diagnosis of any of the following: depression, post-traumatic stress disorder, other psychiatric disorder
* Taking any of the following medications: amantadine, , amphetamine, atomoxetine
Triglyceride Lowering Study

Lovaza is a special fish oil concentrate, that prescribed at 4 g a day to reduce certain fat (triglycerides) levels in blood.Our goal is to study how Lovaza at doses of 4, 8, and 12 grams per day will reduce fats in the blood of the patients with very high level of triglycerides. Our hypothesis is that patients with very high triglycerides will respond more with higher doses of Lovaza (8 g per day and then 12 g per day).

Lovaza contains Omega-3 fatty acids, the family of poly- unsaturated fatty acids. Omega-3 fatty acids stimulate blood circulation, increases the breakdown of fibrin, and additionally has been shown to reduce blood pressure, cardiac events and mortality from congestive heart failure. There is strong scientific evidence that omega 3 fatty acids significantly reduce blood triglyceride levels while elevating high density lipoprotein cholesterol (HDL) levels. Fasting and non fasting hypertriglyceridemia have been associated with atherosclerosis, and coronary heart disease events, even in the absence of hypercholesterolemia. Severe hypertriglyceridemia (\>2000 mg/dl) can also lead to acute hemorrhagic pancreatitis.

Currently, patients having very High TG are treated with Fibric acids (gemfibrozil, Tricor, Antara), and if hyperinsulinemic, with Glucophage. Lovaza (4g/day) has been shown to be effective and safe in lowering TG levels. There is no published data which indicates that Lovaza 8 or 12 g per day would have therapeutic effectiveness in further normalizing triglycerides in subjects on maximized triglyceride lowering and Lovaza 4 g per day. We hypothesize, based on our clinical experience that increasing Lovaza to 8 and then (if necessary) to 12 g/day would safely optimize triglycerides in subjects with primary hypertriglyceridemia who failed to normalize their triglycerides on optimal therapy including Lovaza 4 g/day.

Eligibility Criteria:
Inclusion Criteria:

1. Primary hypertriglyceridemia with fasting TG levels \>1000 mg/dl, and persistence of TG levels \> 500 mg/dl despite maximal TG lowering therapy for 1 month, including Lovaza 4 g/day, fibric acids, and, where indicated, Glucophage for treatment of hyperinsulinemia.
2. Patients with mild to moderately impaired renal function should be initiated on TRICOR 48 mg and patients with severe renal impairment should not be given TRICOR.
3. Absence of exclusionary criteria (see below).

Exclusion Criteria:

1. Patients with known allergy to fish
2. Hypertriglyceridemia secondary to alcoholism, exogenous estrogens, nephrotic syndrome, hemochromatosis, glycogen storage disease, uncontrolled diabetes, exogenous corticosteroids, Cushing's syndrome, uremia).
3. Bleeding gastric or duodenal ulcers, active inflammatory bowel disease.
4. Pregnancy
5. Dementia
6. Patients with bleeding diatheses
7. Patients who are taking concomitant anticoagulants and other medications that affect bleeding time (e.g., warfarin, aspirin)
8. Patients with significantly abnormal transaminases (above 3x of upper normal limit)or any history of liver disease
9. Patients with conditions affecting the skin (e.g. malignancy, vasculitides) that may confound the skin exam.

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Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.

This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Participants from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle;
* Able and willing to give informed consent.

Exclusion Criteria:

* None
Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC

The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.

Patients will be randomized to 2 groups

Eligibility Criteria:
Inclusion Criteria:

1. 18\~70 years
2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
3. Presence of at least one index lesion measurable by CT scan or MRI
4. Ecog0-1
5. Expected life time longer than 12 weeks
6. Normal laboratory values:

   * leucocyte ≥ 4×109/L
   * neutrophil ≥ 1.5×109/L
   * platelet ≥ 100×109/L
   * Hemoglobin ≥ 10g/L
   * ALT and
   * AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
7. Signed written informed consent

Exclusion Criteria:

* Patients have used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception