cyrilzakka/clinical-trials huggingface dataset:
Ketamine vs Hydromorphone

This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.

The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.

The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age

Exclusion Criteria:

* Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?

The research protocol aim is to compare diagnostic tools for the proper evaluation of patient with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE), a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation of patients with positive fecal occult blood as compared to colonoscopy, which is considered the best evaluation method. Colonoscopy involves the direct visualization of the colon using a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in this protocol.

Additional aims of this study are: to determine the localization, number, size and pathologic characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the patient preference between both studies.

This study is limited to those patients 50 years or older who are at average risk for colon cancer and who had a positive fecal occult blood screening test.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic patients older than 50 years of age, with at least one positive FOBT
* Without history of colon cancer and/or polyps
* Gross gastrointestinal bleeding or prior colonoscopy or DCBE
* Who were willing to participate in the study
* Were included in the investigation.

Exclusion Criteria:

* Patients with poor cardio-respiratory condition
* Coagulation deficiency, use of anticoagulants or other drugs affecting coagulation
* Severe renal or liver disease
* Hospitalized patients and palpable abdominal or rectal mass were excluded from the study.
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.


Eligibility Criteria:
Inclusion Criteria:

1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:

   Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
3. Male or female patients 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)

Exclusion Criteria:

1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
3. Patients with a recent history (one year or less) of myocardial infarction.
4. Patients with any unstable or life-threatening cardiac arrhythmia.
5. Patients who have been hospitalized for heart failure within the past 3 years.
6. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
8. Patients with known narrow-angle glaucoma.
9. Patients with asthma or a history of asthma.
10. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
11. Patients with known active tuberculosis.
12. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
Air Pollution and Development in the Boricua Youth Study

This study seeks to understand the relationship between prenatal maternal air pollution exposure and offspring risk for ADHD and examine two potential -modifiable- mechanisms: prenatal maternal inflammation and offspring sleep problems. We will employ a longitudinal neuroimaging study design and leverage a well-characterized intergenerational cohort of Puerto Ricans to address prior literature's limitations. This will be the first study to use infant neuroimaging to disassociate the effects of prenatal pollution exposure from those of postnatal pollution exposure, adversity and disadvantage, and offspring genetic risk for ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Having been enrolled in the BYS-ECHO birth cohort (parent study).
* Speaks English or Spanish.
* Having a parent that is eligible to participate, based on criterial detailed below, and agrees to participation.
* One parent must speak English or Spanish.

Exclusion Criteria:

* Having serious neurological disorder, excluding ASD (e.g., seizure disorder).
* MRI contraindications (irremovable metal in body like braces, pacemakers).
* Claustrophobia.
* Having a parent that is not competent to consent (e.g., severe intellectual disability would have triggered exclusion) or under 18 years of age.
Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women

A real world study to evaluate outcomes in women based on guideline identified fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) cutoffs for ischemia (ischemia defined as FFR ≤ 0.80 and iFR ≤ 0.89).

The WOMEN FiRST (FFR iFR Revascularization Strategies Trial) study collects information from enrolled subjects to create a data repository. The data will be used to further elucidate recommendations for PCI of angiographically intermediate lesions (30-90% stenosis) in epicardial lesions in women by comparing FFR and iFR findings to findings of inducible ischemia on existing non-invasive stress imaging studies. Gender comparisons will also be made from archived and published research data sets from studies comprised up to 80% men. Data will also be stored long term for use in future undefined analyses.

Eligibility Criteria:
Inclusion Criteria:

1. Female ≥ 18 years old at signing of informed consent
2. Suspected myocardial ischemia or acute coronary syndrome
3. Indication for non-invasive perfusion imaging study
4. Indication for diagnostic catheterization
5. Eligible for PCI
6. Signed informed clinical procedural consent by subject or by surrogate

Exclusion Criteria:

1. Inability to receive adenosine or regadenoson (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker.
2. Severe cardiomyopathy (ejection fraction \<30%)
3. Extremely tortuous or calcified coronary arteries precluding FFR/iFR measurements
4. Patients with left main coronary artery disease requiring revascularization
5. Female of child baring age should have negative pregnancy test
6. Subject is pregnant or breast feeding, or planning to become pregnant
7. Contraindication to non-invasive stress imaging including severe claustrophobia, renal disease with GFR \<30 where CMR is indication, any metal in the body which is a contraindication to CMR, allergy to gadolinium contrast
8. ICD or PPM
Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. It has also been found in the circulation of some patients with early stage cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a screening or diagnostic colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition at a very early stage before the patient becomes symptomatic. The results of this study should help define the role of ctDNA in the detection of early stage colon cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign diseases or no abnormalities).

After the participants have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to their scheduled screening or diagnostic colonoscopy. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their primary care physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of colon or other cancer.

Eligibility Criteria:
Inclusion Criteria: .

* 18 years of age or older who are scheduled to undergo a screening or diagnostic colonoscopy by Dr. Phillip Fleshner

Exclusion Criteria:

* Prior history of cancer excluding basal cell carcinoma of the skin
Neural Correlates of Real World Spatial Navigation in Humans

The purpose of this study is to understand the neural mechanisms that support real world spatial navigation in humans using deep brain recordings and stimulation during virtual reality (VR), augmented reality, and real world memory tasks. We will determine the cognitive (i.e., memory) and behavioral (i.e., body, head, eye position and movement) factors that modulate deep brain activity and the consequent effects of memory-enhancing deep brain stimulation.


Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older and has undergone RNS system placement
* Willing to provide informed consent and participate the study
* Ability to read and write English fluently

Exclusion Criteria:

* Unwilling to provide informed consent
Cell-free Fetal DNA Concentration in Cases of Abnormal Placental Invasion .

Cell free fetal DNA might predict abnormal placental invasion

This study aims to evaluate whether measurement of cell-free fetal DNA in the maternal plasma can be predictive of abnormal invasion in cases of placenta previa.

Eligibility Criteria:
Inclusion criteria:

1. Maternal age range from 20-40 years old.
2. Parity: para 1- para 5.
3. Body mass index range from 18-25 kg/m2.
4. Singleton pregnancy carrying male fetuses.
5. Gestational age range from 28-34 weeks.

Exclusion criteria:

1. Multifetal pregnancy.
2. Hypertension, preterm labor and intrauterine growth restriction.
3. Patients taking a tocolytic agent or those with uterine bleeding at or after blood sampling.

   * Since these complications may increase the level of cell-free fetal DNA.
4. Accidental hemorrhage.
MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer

The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
* Stage III B or Stage IV disease
* Age \> or = 70 years
* ECOG Performance status 0 or 1
* Patient at first diagnosis or with recurrence after primary surgery
* At least one target or non-target lesion according to RECIST criteria
* Life expectancy of at least 3 months
* Neutrophils \> 1500/mm3, platelets \> 100,000/mm3, hemoglobin \> 10g/dl
* Creatinine \< 1.5 x the upper normal limit
* AST and ALT \< 2.5 x the upper normal limits (\< 5 x the upper normal limit in the presence of hepatic metastasis)
* Bilirubin \< 1.5 x the upper normal limit
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy for advanced disease
* History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
* Symptomatic cerebral or spinal cord metastasis
* Myocardial infarct within the last 12 months
* Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
* Known or suspected hypersensitivity to any of the drugs used in the study
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent
Quantification of UE Use and Effects of Feedback in the Home Setting

The investigators are proposing a pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:

i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in individuals chronic post-stroke,

ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs, and

iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.

iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally in subjects post-chronic stroke pre and post feedback.


Eligibility Criteria:
Inclusion Criteria:

* Subjects post-stroke
* chronic post ischemic or hemorrhagic cortical or subcortical stroke
* 25 - 100 years old
* upper extremity impairment
* Subjects will need to be able to flex their paretic shoulder and their elbow \> 40° without assist
* able to follow 2-step commands
* community dwelling with or without assistance
* intact superficial light touch sensation in both upper extremities
* must also have some movement in both arms

Exclusion Criteria:

* can't currently have another neuromuscular disorders such as spinal cord injury, traumatic brain injury, Parkinson disease or multiple sclerosis
* no upper extremity injury within the last 3 months
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers

This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50, mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will receive a single study injection of either mipomersen or placebo. Subjects will be enrolled into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design. Dose-escalation will proceed only if there is an acceptable safety profile from the previous dosing level.


Eligibility Criteria:
Inclusion Criteria:

* First generation Japanese (born in Japan of Japanese parents and Japanese grandparents), lived no more than 5 years outside of Japan, with no significant change in lifestyle or habits, including diet, while living outside of Japan.
* Surgically sterile, abstinent or subject or partner compliant with acceptable contraceptive during and 24 weeks after the last study drug dose
* Body weight \>50 kg and body mass index between 18 and 30 kg/m2 inclusive

Exclusion Criteria:

* Clinically significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease
* Clinically significant abnormal findings on the physical examination, ECG, blood pressure, heart rate, medical history, or clinical laboratory results at Screening or before dosing
* Positive test for human immunodeficiency virus (HIV), hepatitis B or C.
* High sensitivity C-reactive protein (hsCRP) \>5 mg/L
* History of or current malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year)
* Evidence of acute or ongoing chronic inflammatory condition or infection
* History of rash, impetigo, or drug allergies
* Alcohol and/or drug abuse
* Smoking more than 10 cigarettes per day
* Planned dental work up to and including Day 8 procedures
* Treatment with another investigational drug, biological agent, or device within 4 weeks of Screening or 5 half-lives of the study agent, whichever is longer
* Use of prescribed medications within 4 weeks or over-the counter medications (including dietary supplements and herbal remedies) within 14 days before the first study drug dose, or use of any concomitant medications (prescribed or over the counter) through Day 8 of the study without Investigator and Sponsor approval. Vaccinations are not allowed beginning 3 weeks prior to the first dose of study drug until completion of the safety follow-up period
* Previous exposure to oligonucleotide-based drug therapy
* Donated 50 to 499 mL of blood within 30 days prior to consent, or \>499 mL within 60 days
Ventricular Pacing Site Selection (V-PASS)

The purpose of this study is to determine whether there is a relationship between ventricular lead position and the incidence of heart failure and atrial fibrillation in patients with indication for permanent pacemaker stimulation.

AV-Block of higher degree is the primary indication for pacing therapy for about 20% of pacemaker patients. Pacing systems with only ventricular stimulation (VVI and VDD) have a fraction of about 40% of all pacemakers in Germany. About 50% of the implanted pacemakers in Germany are dual-chamber pacemakers and one half of them is used for treatment of AV blocks.

Picture 1: Fractions of pacing indications in Germany Picture 2: Fractions of used pacing modes in Germany /1/

A lot of studies proved in the past that the pacing site influenced the development of hemodynamics, heart failure (HF) and atrial fibrillation (AF). Unfortunately, the results are not commonly applicable or statistically assured. Due to this, further examinations are required in order to get explicit statements regarding application of alternative, nonapical ventricular lead positioning.

1. Pilotphase It shall be determined whether a randomized positioning of ventricular leads at 2 defined positions (either Group A: Positioning at right ventricular apex or Group B:. Positioning at right ventricular high septum) is feasible. Included patients will already by examined and followed according to protocol. After having proved feasibility of randomized positioning, the data of these patients shall be used for evaluation of the V-PASS study.
2. Study Phase It shall be evaluated how far 2 defined different ventricular lead positions for permanent pacemaker therapy can influence the combined study endpoint mortality and clinically relevant symptoms of heart failure. Further more the development of hemodynamics and the incidence of atrial fibrillation shall be studied.

Eligibility Criteria:
Inclusion Criteria:

Patients with an expected ventricular stimulation rate of \>60% in planned pacing therapy. This will be the following pacing indications

* Symptomatic first-degree AV block, PQ time \>250ms
* Second-degree Av block with permanent 2:1 conduction
* Permanent third-degree AV block
* Paroxysmal first-degree to third-degree Av block, with an anticipated rate of ventricular stimulation \>60%
* Symptomatic bradyarrhythmia absoluta with permanent atrial fibrillation, with an anticipated rate of ventricular stimulation \>60%

Exclusion Criteria:

* heart failure acc. NYHA III or IV
* Intra-atrial conduction delay (P-wave \> 150ms)
* Myocardial infarction less then 6 months before pacemaker implant
* hypertrophic obstructive cardiomyopathy
* Cardiogenic shock
* pregnancy
* Lactation period
* Patients under 18 years of age
Effectiveness and Safety of Acupuncture for Obesity and Over-weight People

To determine the efficacy and safety of acupuncture for obesity and overweight people in China.


Eligibility Criteria:
Inclusion Criteria:

* The individuals is phlegm-dampness constitution and female.
* Age is between 18 and 45 years.
* BMI is between 24 and 50.
* The individuals voluntarily sign the informed consent form.
* The individuals live in Harbin City of China.

Exclusion Criteria:

* Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases，hyperadrenocorticism, postmenopausal obesity etc.
* The individuals with server cardiovascular and cerebrovascular diseases and cancer.
* Having therapy for obesity in the last three months.
* The individuals do not adhere to the treatment or are with other treatments.
* Female individuals with pregnancy, lactation and planning a pregnancy in the two months.
* Critical patients or patients combined with liver and kidney damage.
* Individuals with visual and auditory memory disorders or psychosis.