cyrilzakka/clinical-trials huggingface dataset:
Impact of Covid-19 in the Emergency Department

To investigate the effects of lockdown in the Emergency Department in a tertiary health care hospital, Nuremberg, Germany.

To investigate the effect of the first lockdown caused by the pandemic of Covid-19 in a tertiary health care hospital. Klinikum Nuremberg is one of the largest tertiary health care hospitals in Germany with two locations in Nuremberg. In the north department, around 150 outcome patients visit the Emergency Department every day.

During the pandemic in 2020 the capacities of the hospitals were saved for the patients with Covid-19. A decrease of patients presented in the ED was noticed. Controlling system and patient management provided the number of cases and correlated with the same period of time one year ago, before the pandemic.

For the classification of severity of diseases, different clinical diseases with severity scores were analyzed. Following diseases and scores were evaluated:

Pancreatitis -- \> ranson score; ACS (acute coronary syndrome) --\> Grace-Score; Pulmonary Embolism -- \> sPESI (simplified Pulmonary Embolism Severity Index); Diverticulitis --\> CDD (Classification of Diverticular Disease); Pneumonia -\> crb65 (Confusion- Respiratory rate- Blood pressure- age ≥ 65 years);

Eligibility Criteria:
Inclusion Criteria:

Only patients who presented in the ED.

Exclusion Criteria:

none
Open Technique Erector Spinae Plane Block in Spinal Surgery

Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles.ESPB has been successfully applied as a part of multimodal analgesia in treating postoperative pain in spinal surgery. However, it may be difficult or impossible to perform lumbar ESPB in obese patients or cases of increased lumbar lordosis. This study aims to investigate the effectiveness of ESPB applied by the intraoperative surgeon.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* Agreed to participate in the study

Exclusion Criteria:

* Patients with infection at the injection site
* Coagulopathy Allergy to amide-type local anesthetics
* History of peripheral neuropathy
* Hepatic and/or renal failure
* Refusing the procedure
* Patients with heart disease
* Patients who have previously undergone surgery from the same area
Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors

The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study.

Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.

Eligibility Criteria:
Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histologically or cytologically confirmed lung cancer.
4. Treated with Immune Checkpoint Inhibitors with or without chemotherapy.

6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
Effects of Fasting in the Bahá'í Faith

The aim of the study is to find out the effects a specific religious fast (i.e. Bahá'í fast) has on certain metabolic parameters, hydration, psyche and circadian clock. In a follow-up questionnaire series in 2019 we want to additionally validate a specific questionnaire for Bahai fasting, which was developed in 2018.

Followers of the Bahá'í Faith worldwide follow a yearly fasting tradition, where they fast intermittently for nineteen days. The intermittent fast is defined as abstinence from any food, drink and smoking from sunrise until sunset. These nineteen days are always in March and so do not coincide with climatic extremes in any country worldwide. This makes this kind of fasting a good model to study the psychological and medical effects of intermittent fasting in humans.

Eligibility Criteria:
Inclusion Criteria:

* member of the Bahá'í religious community, Age between 18-69 years, the study participant must be able to understand the instructions given to him by the study personnel, the performance of the religious fast is planned in 2018 (and for the validation of the questionnaire also in 2019)

Exclusion Criteria:

* An interruption of the religious fast is planned for more than five days, pregnant and nursing women, severe internistic condition, eating disorders (anorexia nervosa, bulimia), terminal or severe disease with marked impairments in mobility and vitality, non-existence of email address and Internet Access (because of online questionnaires), severe psychiatric disorder, simultaneous participation in another Trial

Exclusion Criteria for subsample (energy metabolism measurements and microdialysis)

* Body Mass Index \<18,0 und \>30,9 kg/m2, claustrophobia, clinically relevant haemostaseological conditions or medication, vegan diet, special diet out of medical reasons, current dieting for weight loss, weight loss of more than 2 kg in the month before the study commenced, postsurgical conditions, acute and chronic infections, known drug or alcohol abuse
* additional exclusion criteria for microdialysis (subsample of energy metabolism measurements): allergy to local anaesthetics
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month old infants (42 to 98 days)
* Available for the duration of the study and reachable by telephone

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
* Receipt of blood products or gamma globulin
Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer: SNAC Study

Based on the concerns about the actual low strength of evidence of the efficacy of NAC on survival of proper gastric cancer treated with adequate D2 gastrectomy as compared to the results of optimal upfront surgery (S), and considering the actual difficulties of additional RCTs, the aim of this study is to assess the non-inferiority of upfront surgery alone with optimal D2 dissection compared to NAC regimens followed by surgery. Methods: This is a nationwide Multicenter observational retrospective study with matched comparison of two therapeutic strategies (NAC vs S). We will include patients with cT\>2, every cN M0, or with every T and N+ M0, histologically proven adenocarcinoma of the stomach, submitted either to pre- or peri-operative treatment and D2 gastrectomy or to upfront D2 gastrectomy, between January 2012 and December 2019, followed by adjuvant treatment when recommended.

All patients matching the inclusion/exclusion criteria will be registered into the study and classified into one of the two arms: a, patients who underwent pre- or perioperative treatment and D2 gastrectomy (NAC) or b, patients submitted to upfront D2 gastrectomy (S). Given the results reported in the "FLOT" trial, a 3-years OS of 55% in the control arm (NAC) was assumed. Three-year OS in the experimental arm (S) was assumed to be 47.4% under the null hypothesis of inferiority and 55% under the alternative hypothesis of non-inferiority. A sample size of 684 patients (342 in each arm) achieves 80% power to detect a non-inferiority margin Hazard Ratio of 1.25


Eligibility Criteria:
Inclusion Criteria:

* 3.1.1. Locally advanced (T\>2 any N or N+ any T) histologically proven adenocarcinoma of the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs.

3.1.2. D2 lymphadenectomy (based on Japanese gastric cancer guideline) 3.1.3. Age \> 18 years 3.1.4. surgical resectability 3.1.5. follow-up time of at least 36 months.

Exclusion Criteria:

3.2.1. distant metastases (cM+) or infiltration of adjacent structures or organs (cT4b) and all primarily not resectable stages 3.2.2. Other types of lymphadenectomy lower than D2 3.2.3. Siewert type I and II Cardia cancers 3.2.2. Relapsed gastric cancers 3.2.3. malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)

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Evaluation of the Effectiveness of a Topical Medical Device in Wound Healing and Symptom Relief in the Postoperative Period of Open Excisional Hemorrhoidectomy (The Emor Study)

This multicenter randomized controlled phase IV trial aims to compare the clinical efficacy of a gel containing a Propionibacterium extract and a gel with hyaluronic acid and silver sulfadiazine in the degree of epithelialization of post-operative wounds of open excisional hemorrhoidectomy.

The main questions it aims to answer are:

* To compare the efficacy of the two medical devices in the degree of epithelialization in the postoperative period of open excisional hemorrhoidectomy, at 0, 10, 20 and 40 days from the beginning of treatment.
* To evaluate the effectiveness of these devices in alleviating: pain, itching, burning, and the type of bowel habit Participants will be randomized, at the beginning of the study, to one of the two treatments, and the efficacy of the two medical devices will be evaluated at 0, 10, 20 and 40 days from the start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Open excisional hemorrhoidectomy, with removal of at least 3 groups
* Age between 18 and 75 years

Exclusion Criteria:

* Patients who do not consent to the study
* Opioid-dependent patients, chronic use of analgesics
* Fecal incontinence
* Anorectal neoplasms
* Immunosuppressive treatments (e.g., chemotherapy, radiotherapy, etc.)
* Chronic inflammatory bowel diseases
* Pregnancy
* Patients with major psychiatric disorders
* Known allergy to the components of the treatments under study
Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

This is a randomized cross over trial to compare quality of life and product performance between Icon reusable underwear versus standard disposable pad in patients with mild to moderate urinary incontinence.

Urinary incontinence is estimated to affect approximately 1/5 of all women in the United States. Multiple studies have compared effectiveness, cost-effectiveness and comfort of a variety absorbent products but most of the current data compares daily disposable insert pads. Icon reusable underwear is a new product on the market for light incontinence (25-30mL daily). The primary objective of this randomized cross over trial is to compare quality of life and patient comfort and to determine patient preference using Icon reusable underwear versus standard incontinence pad in the management of urinary incontinence. The secondary objective is to compare the cost-effectiveness of ICON underwear to disposable pads. Women with small to moderate urinary incontinence to use either ICON underwear or pads for two days and then crossed over to use other product for two days. The primary outcome measures were Incontinence Quality of Life Instrument 3 (I-QOL) and Product Performance Questionnaire 4 (PPQ) after use of each product. A sample size of 70 was calculated to detect a difference of 10.0 in the I-QOL to achieve a power of 80% with a significance level of 0.05 and to account for a 20% attrition.

Eligibility Criteria:
Inclusion Criteria:

* Female patients who are at least 18yo
* Mild to moderate urinary incontinence, defined as a response "small" or "moderate" amount to the ICIQ-SF question - "How much do you leak?"

Exclusion Criteria:

* Active urinary tract infection
* Fecal incontinence, defined as a response "large" amount to the ICIQ-SF question - "How much do you leak?"
Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice

The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence.


Eligibility Criteria:
Inclusion Criteria:

* Individuals must meet criteria for moderate/severe opioid use disorder, report past month opioid misuse, and be physically dependent on short-acting opioids (e.g., heroin, hydromorphone, fentanyl), as evidenced by either urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening.
* History of intravenous opioid use.
* Baseline O2 saturation of 95% or greater.
* Between the ages of 18-50 years.
* Female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence). Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.
* Able to speak and read English.
* Otherwise healthy.

Exclusion Criteria:

* History of, or current, clinically significant physical disease (e.g., respiratory disease \[asthma, COPD, sleep apnea\], impaired cardiovascular functioning, seizure disorder or CNS tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder.
* Meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (OUD subjects only) or nicotine/caffeine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). Negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening.
* Contraindications for MRI scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device).
* Vision or hearing problems that would preclude completion of experimental tasks.
* Poor venous access.
* Regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins or short-term antibiotic prescriptions.
* At risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed.
* Seeking treatment for SUD or currently taking buprenorphine or methadone as the primary opioid of use.
The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery

This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.


Eligibility Criteria:
Inclusion Criteria:

* patient in Nord-Trøndelag 2-4 years after Roux-en-y gastric bypass surgery
* visits Namsos outpatient clinic for follow-up.
* having at least 3 symptoms of hypoglycemia presented in the dumping severity scale (DSS).
* at least one of these symptoms must be a neuroglycopenic symptom
* all these symptoms have an intensity of 2 or 3 on DSS.

Exclusion Criteria:

* severe surgery-related complication
* revisional surgery
* life threatening health conditions.
* diabetes mellitus or other metabolic diseases
* pregnancy or breast feeding
Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide

Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics and hypertensive with renal insufficiency (observed data) in the study population, with the objectives of the High Authority for Health recommendations (benchmark)


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients already treated for at least 1 month with Telmisartan plus hydrochlorothiazide, consulting the physician consecutively for whatever reason

Exclusion Criteria:

* NA
Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects

The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK) between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18 to 55 years. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
* History of being a nonsmoker for at least 1 year.
* Subjects have to be either extensive CYP2D6 metabolizers with a normal complement of 1 or 2 fully active enzyme gene alleles or poor CYP2D6 metabolizers (lack of active enzyme gene alleles) via genetic testing of a blood sample.

Exclusion Criteria:

* Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease or any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure).
* Known or suspected alcohol abuse or consumption of more than 2 standard units per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine) within the past 6 months.
* Known or suspected current abuse of prohibited drugs or other substances. Use of any hormonal therapy within 30 days before study day -1 until the end of the partial inpatient confinement period.
Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

The objective of this pilot study is to perform a set of pressure and flow rate measurements in order to quantitatively characterize safe irrigation or "flushing" of a ventricular shunt catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery. This maneuver involves injecting saline with a syringe to clear plugged shunt catheters. Based on data obtained in Stage I of the study, a device has been fabricated which provides the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure and flow rate measurements generated by this specialized flusher device will be collected and measured.

Primary Objective: To collect pressure and flow rate measurements during shunt revision surgeries in human patients.

Pressure recordings of the injected fluid will be obtained using disposable off-the-shelf sterile pressure transducers (which are typically used for intracranial and arterial pressures monitoring) readily available in the operating room. First, the surgeon will attempt to flush the catheter using the Alcyone in-line Flusher device. If this fails, the surgeon may elect to attempt to flush using a standard syringe attached to the catheter. The flow rates will be measured by video, recording the syringe during the flushing maneuver, and then extracting plunger motion information by applying image processing on the acquired videos. In the event the recording equipment is not available (in that these operations are usually unscheduled and sometimes urgent), the same irrigation techniques may be used without the pressure recordings.

Secondary Objective: To analyze the collected data and establish maximal allowable injection pressure and flow rate. The collected data segments for each patient will be analyzed and maximal values for pressure and the saline injection rate will be recorded in a spreadsheet. Inter-patient variation in the results, presumably due to different degrees of occlusion, will be statistically evaluated. We will also determine if any of the catheters which appear occluded in the operating room resume flow with the flushing maneuvers.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 30 days to 35 years of age, of any race or gender.
2. Subjects must be scheduled to undergo a neurosurgical procedure potentially requiring a revision of neurosurgical catheters.
3. Subjects aged \>18 years of age must be willing and able to provide written informed consent. Parental consent will be required for minors.

Exclusion Criteria:

1. Inability or unwillingness of subject or parent/guardian to give informed consent/assent.
2. Judgment of the investigator, surgeon, or any member of the care team (including anesthesiology or operating room nursing staff) that participation in the study will interfere with, or be detrimental to, administration of optimal healthcare of the subject.
3. Inability or unwillingness of subject to endure the test or any other condition that would preclude or bias the results of the study according to the judgment of the investigator.