cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* Male or female equal or greater than 18 years of age at Screening
* Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
* Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
* American Society of Anesthesiology (ASA) Physical Class 1-4
* Able and willing to complete with all study visits and procedures
* Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
* Willing and capable of provide written informed consent.

Exclusion Criteria:

* Pregnant, nursing or planning to become pregnant during the study period
* Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
* Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
* Single-column hemorrhoidectomy
* Body weight less than 50 kg (110 pounds)
* History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
* contraindication to epinephrine
* contraindication to any of the pain-control agents planned for postoperative use
* Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
* History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
* Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
* Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
* Any clinically significant event or condition uncovered during surgery
* A cumulative incision length less than 3 cm
Immunological Markers Predictive of Response and Toxicity to Checkpoint Inhibitors in Non-small Cell Lung Cancer

A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.

The study will run for 12 months with a 6-month follow-up at the inclusion of the last patient.

Patients will be included from the initiation of immunotherapy treatment regardless of the line.The routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, RF, LDH, complement (C3 C4), anti-tissue antibodies, lymphocyte immunophenotyping). This assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy.

The investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Metastatic non-small cell lung cancer
* Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice
* No objection made

Exclusion Criteria:

* Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy.
* Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day)
* Patient with prior checkpoint inhibitor therapy
* Patient with a contraindication to immunotherapy
* Patient under legal protection
* Refusal to participate
Biomarkers And Neurological Outcome in Neonates (BANON)

Validation of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

The aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk.

The population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

Eligibility Criteria:
Inclusion Criteria:

* Need for resuscitation after birth: For \>1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions
* 5 min APGAR-score ≤ 5.
* Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at \<30min of age
* Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at \<30min of age.

Exclusion Criteria:

* Age \>1.5h
* gestational age \< 36 weeks
* birth weight \<2000g
* congenital malformation
* missing valid written informed parental consent
* unsuccessful resuscitation
* infant considered not-viable
* decision for palliative care only
Strength for Health

Despite a robust literature on the benefits of exercise for cancer survivors, most of the research to date falls in two primary areas - aerobic exercise and breast cancer survivors. The focus on aerobic training alone is a concern as resistance training is critical for building the muscle mass necessary to maintain physical function. However, concerns have been raised about the potential for higher than tolerated adverse event rates during resistance training, particularly that which is unsupervised, despite a history of safe use of resistance training in other chronically diseased patient populations. The aim of this pilot study is to demonstrate the feasibility, safety and quality of life benefit of a home-based resistance-training program among colorectal cancer survivors. The investigators will recruit n=30 men and women with stage I-III colon cancer. Participants will be randomized to a home-based exercise intervention that combines aerobic and resistance exercise. Control arm participants will receive a home-based meditation program.

The investigators will recruit n=30 patients with stage I-III colorectal cancer and randomize them to a 12-week resistance training intervention with Theraband and existing evidence- based materials or attention control using a meditation intervention. Using an electronic survey tool, patients will complete a baseline questionnaire on key outcomes (quality of life, fatigue, side effects) and potential confounders and will consent to a medical record review. These will also be assessed via at 4 weeks post randomization and 12 weeks post randomization. Participants in the intervention group will receive one-time in person instruction in the exercises derived from the existing evidence base of home-based resistance training programs for older adults and cancer survivors. They will be sent home with a book demonstrating the exercises, a log and a set of appropriate resistance bands. Weekly follow-up calls will occur for the duration of the intervention and updates on the call results will be provided to the colon cancer clinic nurse so that care is integrated. Participants in the attention control group will be mailed a meditation CD. Follow-up in the control group will parallel that of the intervention group, with weekly calls.

Eligibility Criteria:
Inclusion Criteria:

* stage I-III colorectal cancer
* completed surgical treatment
* at least 12 weeks post-surgery.
* at least 4 weeks post adjuvant therapy.
* age 18 and older.

Exclusion Criteria:

* patients who had surgery more than 24 months ago.
* patients with related pre-existing conditions (i.e., Crohn's disease, ulcerative colitis, familial polyposis syndromes).
Lung Ultrasound Score and Weaning Outcome

Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU.

Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.

Methods: A prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.

Eligibility Criteria:
Inclusion Criteria:

- 1. Patients age \> 18 years

2. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.

Exclusion Criteria:

* 1. Patients \< or =18 years 2. Patients with left ventricular failure

  3. Right ventricular failure

  4. Pulmonary hypertension

  5. Aortic valve disease

  6. Hyperthyroidism

  7. Tracheostomy
A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension


Eligibility Criteria:
Inclusion Criteria:

1. Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions

   * sitSBP\<180 mmHg and sitDBP\<110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
   * 140mmHG≤sitSBP\<180mmHg and 60mmHg≤sitDBP\<110mmHg
2. Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions

   * 24h-ABPM: 130mmHg≤ SBP \<170mmHg
   * clinic BP: 140 mmHg ≤ sitSBP \< 180 mmHg and 60 mmHg ≤ sitDBP \< 110 mmHg

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
3. Orthostatic hypotension with symptoms within 3 months prior to visit 1
4. Secondary hypertension patient or suspected to be
5. Uncontrolled type II diabetes mellitus (HbA1c \> 9%) or type I diabetes mellitus
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Severe renal diseases (eGFR\<30mL/min/1.73m2)
9. Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
10. Hypokalemia or Hyperkalemia (K\<3.5mmol/L or K ≥ 5.5mmol/L)
11. Hyponatremia or Hypernatremia (Na\<135mmol/L or Na ≥ 155mmol/L)
12. History of malignancy tumor
13. History of alcohol or drug abuse
14. Positive to pregnancy test, nursing mother, intention on pregnancy
15. Considered by investigator as not appropriate to participate in the clinical study with other reason
A Simplified Test to Assess Flavor in COVID-19 Patients

The Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances.

The original flavor test has been simplified, with the great advantage to be self-administrable for COVID-19 patients in isolation, without any risk to health professionals.

Smell and taste dysfunctions (STDs) are symptoms associated with COVID-19 syndrome, even if their incidence is still uncertain and variable. In this study, the effects of SARS-CoV-2 infection on chemosensory function have been investigated using both a self-reporting questionnaire on smell and flavor perception, and a simplified flavor test. A total of 111 subjects (19 hospitalized \[HOS\] and 37 home-isolated \[HI\] COVID-19 patients, and 55 healthy controls \[CTRL\]) were enrolled in the study. The flavor test used consists in the self-administration of four solution with a pure olfactory stimulus (coffee), a mixed olfactory-trigeminal stimulus (peppermint), and a complex chemical mixture (banana).

After SARS-CoV-2 infection, HOS and HI patients reported similar frequency of STDs, with a significant reduction of both smell and flavor self-estimated perception.

The aromas of the Flavor test were recognized by HI and HOS COVID-19 patients similarly to CTRL, however the intensity of the perceived aromas was significantly lower in patients compared to controls.

This suggests that a chemosensory impairment is present after SARS-CoV-2 infection, and the modified "flavor test" could be a novel self-administering objective screening test to assess STDs in COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years of age) that gave their written informed consent to the study
* Diagnosis of COVID-19 was confirmed by PCR of nasopharyngeal swab (HI or HOS)
* Negative COVID-19 nasopharyngeal swab (CTRL)
* Subjects with no critical conditions and able to understand the protocol

Exclusion Criteria:

* nasal obstruction or previous nasal diseases
The Swiss Glucose Variability Study

The purpose of this study is to explore long term glucose variability of a combination therapy of metformin and vildagliptin compared to a metformin - gliclazide combination.

Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

1. Male or female patients aged =30 -= 75 years.
2. History of type 2 diabetes for at least 6 months.
3. Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with HbA1c of 6.5-9.0%.
4. Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with a body mass index (BMI) of 25-40 kg/m2.
5. Patients that are currently treated with metformin, gliclazide or both but not with other glucose lowering agents.
6. Outpatient.
7. If female of childbearing potential: Will to practice reliable birth control measures \[e.g., surgical sterilization, hormonal contraception, double-barrier methods (any double combination of IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)\] during study treatment and for at least 28 days after completion of study medication; not lactating or pregnant; and has a documented negative pregnancy test result at baseline.

Exclusion criteria:

1. Type 1 diabetes as defined by the American Diabetes Association (ADA).
2. Type 2 diabetes currently (last 3 months) treated with insulin or glitazones.
3. Acute or chronic diseases causing tissue hypoxia such as:

   * cardiac or respiratory insufficiency
   * myocardial infarct within the last 6 months
4. Active liver disease with alanine aminotransferase (ALAT) and / or aspartate aminotransferase (ASAT) \> 3 x upper limit of normal.
5. Relevant kidney disease such as :

   * serum creatinine =133 µmol/l in males and \> 124 µmol/l in females
   * proteinuria \> 300 mg/l
   * status post kidney transplantation
   * severe infection
   * intravascular administration of contrast medium containing iod within the last 7 days
6. Severe neuropathy (vibration perception at the base of the big toes \<2/8).
7. Active proliferative diabetic retinopathy.
8. Any clinically relevant major organ system disease including mental illnesses
9. History of malignancy
10. Pancreatitis
11. Porphyria
12. Severe disturbances of the adrenal gland
13. Severe disturbances of the thyroid gland
14. Allergy to vildagliptin or one of the excipients
15. Allergy to metformin or one of the excipients
16. Allergy to gliclazide, sulfonylurea or sulfonamides or one of the excipients.
17. Drug or alcohol abuse.
18. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
19. Any other condition that could interfere with the participation in the study according to the study protocol or with the ability to cooperate and comply with the study procedures.
20. Treatment with any investigational drug, within 30 days or 5 half-lives before screening, whichever is longer.
Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)

The purpose of this study is to evaluate the quality of the RNA and the reproducibility of gene expression profiling from liver tissue samples obtained by fine needle aspiration.


Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic hepatitis C (Genotype 1)
* Patient has the ability to avoid use of anticoagulants, nonsteroidal anti-inflammatory drugs and aspirin for at least 5 days before the liver biopsy

Exclusion Criteria:

* Patient has received any approved or investigational drugs for the treatment of hepatitis C in the six months before the liver biopsy
* Patient has HIV or Hepatitis B virus
* Patient has been diagnosed with liver cancer
* Patient has evidence of cirrhosis on any previous liver biopsy
* Patient has confirmed alcohol abuse in the last 12 months
* Patient has participated in any investigational drug study within 90 days before the current study
Treatment Intensity - Apraxia of Speech

A growing neurorehabilitation literature suggests that intense treatment may be desired to maximize the effects of therapy following neurologic injury. This investigation is designed to facilitate the development of efficacious, clinically applicable treatment for acquired apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week vs. 3 hours per week, while holding total number of sessions constant) with a group of speakers who have chronic apraxia of speech and aphasia.

This research was designed to examine the effects of treatment intensity on outcomes associated with an established treatment for acquired apraxia of speech (AOS). Intensity in the form of dose frequency and total intervention duration was evaluated with Sound Production Treatment (SPT). The investigators examined the effects of intense dose frequency (nine, one-hour sessions per week) and traditional dose frequency (three, one hour sessions per week). Total number of treatment sessions was held constant allowing for comparison of total intervention duration (27 sessions over 3 weeks versus 27 sessions over 9 weeks). A two-phase, group cross-over design was used. Thirty-six participants with chronic aphasia and AOS were recruited. Twenty-four participants completed then entire study and were quasi-randomly assigned to one of two treatment groups - intense first or traditional first (12 per group). One group received SPT applied with intense dose frequency (SPT-I) followed by SPT applied with traditional dose frequency (SPT-T). The other group received the treatments in the reverse order (SPT-T followed by SPT-I). A two week no treatment interval separated the treatment phases. The outcomes of interest addressed changes in trained and untrained speech behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Veterans and non Veterans
* Males or females
* Stroke survivor who is at least 4 months post-stroke
* Speaker of English since childhood
* Ability to pass a pure-tone hearing screening (aided or unaided)
* currently non-hospitalized
* Age 21 to 90 years

Exclusion Criteria:

* neurological condition other than stroke
* currently clinically depressed
* history of speech/language problems prior to stroke
* untreated psychopathology
ATX-101 Abdominoplasty

Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects undergoing planned abdominoplasty

Exclusion Criteria:

* History of interventions in the abdominal area
Evaluation of an Algorithm for Length Based Weight Estimation

The purpose of this prospective single center study is to investigate if a developed algorithm is more accurate than the pediatric emergency tape (Alpha 1 Werbedesign e.K., Falkenberg, Germany). For this study 500 patients are required to collect anonymized data (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist that the algorithm has a better accuracy than the pediatric emergency tape (53% are in a +/- 10% interval).

This prospective single center study is performed at the university children's hospital zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16 years and with a body length suitable for the emergency tapes can be included in this study. Patient and parental information is performed during the pre-anaesthetic visit. After written consent the patient will be included. Patient´s length and weight will be measures earliest one day before data collection. Data collection during anaesthesia has no influence on the daily anaesthesia routine and has no impact on patient safety and anaesthesia. Patient's data is made anonymous for further inspection.

Data is documented in Microsoft Excel and statistical analysis calculated with SPSS. 500 patients are needed for a power of 80%. Primary outcome parameter is length-based weight estimation, secondary outcome parameters are length-based age estimation and the correctness of recommended anaesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). Both tools (algorithm and pediatric emergency tape) will be compared with eachother regarding primary and secondary outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* body length suitable with the investigated emergency tapes
* all patients aged 0 -16 years
* receiving general anaesthesia with intubation

Exclusion Criteria:

* Already included in this study once
* missing patient or parental consent