cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.

A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 years and older.
* Clinical diagnosis of hepatitis C with GT1b.
* Chronic hepatitis C treatment-naive participants.
* Interleukin 28B genotype CC.
* HCV ribonucleic acid \> 10,000 international units/milliliter at screening.
* Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin.
* Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin.
* Willing to participate in all study activities and all study requirements.

Exclusion Criteria:

* Body mass index \> 36 kilograms/meter squared.
* Pregnant or nursing females.
* Clinically significant laboratory abnormalities at screening.
* Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
* Human immunodeficiency virus infection or other liver diseases.
* Positive hepatitis B surface antigen.
* Liver cirrhosis.
* Uncontrolled psychiatric disease.
* Clinical evidence of chronic cardiac disease.
* History of malignancy of any organ system within 5 years.
The Study of High-protein Nutritional Support Impact on Postoperative Outcomes in Patients With Primary Lung Cancer

The study was aimed to evaluate the impact of perioperative nutritional support with high-protein mixtures on the risk of postoperative complications, postoperative recovery of respiratory functions in patients with lung cancer, nutritional status and quality of life of patients. Possible adverse events were also studied and described.

The study enrolled 114 patients with primary non-small cell lung cancer and nutritional deficiencies or at risk of developing them, admitted for surgical treatment and meeting other inclusion/exclusion criteria. Patients were randomly divided into two groups: the study group of 57 people and the control group of 57 people.

Patients in the study group, in addition to the usual diet, received nutritional support. During the hospital stay, additional nutritional support was added to the patient's standard hospital diet. On an outpatient basis, patients received the required amount at their disposal and will take it as a supplement to his usual and habitual diet.

Patients in the control group followed the standard hospital diet, and at discharge - the usual habitual diet.

The study was conducted using Enrollme.ru electronic platform. In total, the study comprised screening and 5 visits.

Eligibility Criteria:
Inclusion Criteria:

* Presence of morphological verification of non-small cell lung cancer (NSCLC) without distant metastases;
* Appointment of surgical treatment for primary lung cancer with anatomical resection of the lung (lobectomy, bilobectomy or pneumonectomy);
* Nutritional deficiency or risk of its development (≥3 points on the Nutrition Risk Screening 2002 (NRS-2002) scale);
* No history of nutritional support;
* ECOG (Eastern Cooperative Oncology Group Performance Status Scale) score 0 - 2;
* Life expectancy over 3 months;
* Absence of serious diseases of the gastrointestinal tract, disorders of the liver, kidneys, systemic blood diseases and metabolic disorders at the time of inclusion in the study;
* Absence of severe uncontrolled concomitant chronic diseases and acute diseases (including infectious ones);
* Availability of signed informed consent for inclusion in the study and processing of personal data

Exclusion Criteria:

* Terminal state of the patient, ECOG (Eastern Cooperative Oncology Group Performance Status Scale) 3-4;
* State of refractory cachexia;
* Bleeding, serious injury or blood transfusions in the previous 6 months;
* Decay / abscess in the area of the tumor lesion;
* Presence at the same time of a tumor process of another localization, metastatic lesion of the lungs;
* The presence of concomitant diseases in the stage of decompensation;
* Pregnancy or lactation;
* Allergy to or intolerance to any of the components of Nutridrink Compact Protein, galactosemia, allergy to cow's milk proteins;
* The presence of contraindications to the use of enteral nutrition
* Participation in another study currently or in the past 30 days;
* Any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study
Effect of Spinal Dexamethasone During Transuretheral Prostatectomy

Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone in Transuretheral prostatectomy.

Spinal anesthesia for endoscopic urology surgery like transurethral resection of the prostate is a well-established technique. Opioids are extensively used as an adjunct to local anesthetics in neuraxial blockade to enhance the duration of postoperative analgesia. However, worrisome adverse effects like pruritus, urinary retention, postoperative vomiting and respiratory depression limit its use. The aim of this study was to investigate the effectiveness of Intrathecal dexamethasone as adjunct to local anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* Age: 50-75 yr ASA class I,II, and III undergoing Transuretheral prostatectomy under spinal anesthesia

Exclusion Criteria:

* Contraindications to spinal anesthesia, Allergy to the study medication, Thyroid disease, Parkinson's disease Patients receiving vasodilators or medications likely to alter thermoregulation.
Feasibility of Fasting & Exercise in Pts With HR+ MBC

This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.

This is single-arm feasibility pilot study exploring whether a combined prolonged nightly fasting (POF) and exercise program could impact hyperglycemia and other adverse metabolic consequences of PI3 kinase inhibitors in women with metastatic breast cancer (MBC).

Women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. Some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. This study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. This study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer.

The research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program.

Participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures.

It is expected that about 30 people will take part in this research study

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer
* Postmenopausal (including concurrent use of ovarian suppression)
* Initiating endocrine therapy in combination with:

  * Cohort 1: alpelisib
  * Cohort 2: palbociclib
* Self-reported ability to walk two blocks
* \> 18 years of age
* Approval from treating oncologist, confirmed via email or in writing
* Ability to read and understand English

Exclusion Criteria:

* Diagnosis of diabetes requiring medication
* Engaging in \>90 minutes of moderate or vigorous physical activity per week
Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design

The purpose of this study was to determine if insoles with removable pegs could effectively reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for guidance of peg removal.

The investigators tested the effect of plantar pressure reduction in four conditions:

1. insole of the original shoe
2. peg assist insole but the pegs are not yet removed
3. peg assist insole and the pegs were removed
4. condition3. plus arch support to the insole

Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed type 2 diabetes with neuropathic foot were recruited from the outpatient endocrinology and metabolism division of Taichung Veterans General Hospital in central Taiwan

Exclusion Criteria:

* The exclusion criteria were history of lower extremities amputation, major foot deformities, presence of active plantar foot wound or ulcer, and difficulty walking more than 100 m.
Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy

In this population-based cohort study, data on patients diagnosed with nmGaC in 2004 through 2016, managed with resection and chemotherapy, followed up until the end of 2016, and surviving ≥1 month were retrieved from the US Surveillance, Epidemiology, and End Results-18 Program. Cumulative mortality functions were calculated. Prognostic factors for heart-specific mortality were evaluated using both multivariable-adjusted Fine-Gray subdistribution and cause-specific hazard functions.


Eligibility Criteria:
Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with microscopically-confirmed first primary invasive adenocarcinoma of the stomach (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16) without distant metastasis. Only those who underwent resection in January 2004 through December 2016 were included. Cancers of other histology types including squamous cell carcinoma, gastrointestinal stromal tumor or sarcoma, neuroendocrine tumor or carcinoid, lymphoma, and germ-cell tumor were ineligible, as were patients with non-gastric cancers involving the stomach, with benign or in situ tumors, or with other malignancies before gastric cancer. We further excluded patients with diagnosis based on death certificate only or autopsy, with missing follow-up period, survival status, or cause of death, or with unknown metastasis status. Cancers with distant metastasis were excluded since resection is not routinely recommended for them. Data before 2004 were not included, as the TNM stage information was unavailable. To minimize the effect of perioperative events on survival, we excluded patients surviving \<1 month. No restrictions were applied to age, and patients ≥80 years only comprised 5% of those receiving both resection and chemotherapy.
Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests

This is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. Three study sites will be involved, each testing one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub.

The specific objective of this study is to determine the stability of immunotherapy extract dilutions. Higher dilutions (lower potency) have been shown in vitro to decrease in potency over time more rapidly than less dilute preparations. The investigators hope to determine whether there is a detectable difference in skin test reaction of dilutions of three common antigens (Cat, Timothy Grass, Dust Mite). The diluents used strongly affect the strength when extract potency is tested in vitro. Therefore, the investigators expect to find a detectable difference in skin test potency based on the diluents used (Saline vs. HSA Saline \[300mcg/ml\]).

Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.

  2. Subjects of either gender, ages 18-60 years, with a history of allergic rhinitis related to exposure to the allergen of interest.

  3. Previous positive routine skin test to the allergen to be tested: minimum 5mm wheal diameter with 10,000BAU/mL cat or minimum 5mm wheal diameter with 10,000AU/mL Dermatophagoides farinae or minimum 8mm wheal diameter with timothy 100,000BAU/mL.

  4. AND (in addition to #3) sum of erythema after SPT of at least 50mm or erythema in largest diameter of at least 30mm.

  5. Subject's skin coloring should permit evaluation of erythema. 6. Ability to stop medication that might interfere with the results of the skin prick test.

Exclusion Criteria:

- 1. Spirometry with FEV1 below 80% of predicted normal value and/or poorly controlled asthma 2. Known pregnancy 3. Patients with a history of anaphylaxis or severe allergic reactions. 4. Patients with absolute necessity of antihistamines to control their allergies 5. Patients with active and extensive atopic dermatitis. 6. Patients that take psychotropic medication. 7. General skin hyperreactivity (Negative control greater than 3 mm wheal diameter) or with known tendency for dermatographic urticaria.

8. Patients currently under allergen immunotherapy treatment or with a history of immunotherapy treatment within the last 5 years to the extract to be tested in this study
The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function

Intra- abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are a cause of organ dysfunction in critically ill patients. IAH develops due to abdominal lesions (primary IAH) or extra-abdominal processes (secondary IAH). Secondary IAH arises due to decreased abdominal wall compliance and gut edema caused by capillary leak and excessive fluid resuscitation. Decreasing intra-abdominal pressure (IAP) using decompressieve laparotomy has been shown to improve organ dysfunction. However, laparotomy is generally avoided in patients with secondary IAH due to the risk of abdominal complications.

Acute kidney injury (AKI) is one of the first and most pronounced organ failures associated with IAH and many patients with AKI in the ICU require renal replacement therapy (RRT). Fluid removal using continuous RRT (CRRT) has been demonstrated to decrease IAP in small series and selected patients.

The aim of this study is to evaluate whether fluid removal using CVVH in patients with IAH, fluid overload and AKI is feasible and whether it has a beneficial effect on organ dysfunction (compared to CVVH without net fluid removal).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18y old) of either gender
* Admitted to the ICU
* Sedated and mechanically ventilated (and expected to remain so for at least 48h)
* Informed consent given
* admitted to the ICU for \<7 days or during the first 7 days of a new shock episode
* AKI requiring RRT according to treating physician
* IAP \>12mmHg being attributed to fluid overload by treating physician

Exclusion Criteria:

* Included in the same study before
* Vasopressor and/or inotrope dose needed above noradrenaline 1µg/kg/min and dobutamine 10µg/kg/min
* PaO2/FiO2 ratio \<100
NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

This is a prospective, single-arm, phase II study of 32 evaluable patients treated with NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy for hormone receptor positive (HR+), \[i.e. Estrogen Receptor positive (ER+) and/or Progesterone Receptor positive (PR+)\] HER2+ localized, non-metastatic stage I - IIb breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide signed, written informed consent
* Histologically or cytologically confirmed non-metastatic adenocarcinoma of the breast (stage I-II)
* Candidate for curative-intent treatment
* ER+ and/or PR+ and HER2-positive (Fluorescence In Situ Hybridization-positive or 3+ by Immunohistochemistry staining)
* Life expectancy greater than 5 years
* Left Ventricular Ejection Fraction \> 50% at baseline (within 30 days of day 0)
* Eastern Cooperative Oncology Group performance status ≤2
* Absolute Neutrophil Count \>1000/µL
* Platelets ≥50,000/µL
* Hemoglobin \>8.0 g/dL,
* Creatinine ≤3.0 x upper limit of normal (ULN)
* Bilirubin ≤3.0 x ULN
* Aspartate aminotransferase or Alanine aminotransferase \<5.0 x ULN
* Negative serum pregnancy test for women \<12 months after the onset of menopause unless surgically sterilized
* Agreement by women of childbearing potential and male participants with partners of childbearing potential to use a "highly effective", non-hormonal form of contraception or two "effective" forms of non-hormonal contraception by the patient and/or partner.

Exclusion Criteria:

* Active infection
* Presence of known metastases (stage IV disease)
* Pregnant or lactating women
* Prior chemotherapy or radiation therapy for the primary breast cancer
* Concomitant malignancies or previous malignancies within the last 5 years except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
* Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary or metabolic disease including diabetes, wound healing disorders, ulcers or bone fractures)
* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipated need for major surgery during the course of study treatment
* Current known infection with Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) or Hepatitis C Virus (HCV)
* Receipt of intravenous antibiotics for infection within 14 days prior to receiving study treatment
* Current chronic daily treatment with corticosteroids (dose \>10 mg/day methylprednisolone equivalent) except inhaled steroids
* Known hypersensitivity to any of the study drugs
* Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol
Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA

The multi-centered, cross-sectional investigations shall be conducted in this study with the objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.

This multi-centered, cooperative and epidemiological observation study is so designed to investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer because such a ratio has not yet been adequately clarified in Japan.

The newly diagnosed eligible patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer shall be asked to participate in this study in order of diagnosis. After obtaining their consents by the written informed consent following appropriate explanation, investigations about the demographic information including the cancer family history shall be performed. Subsequently, blood is collected for investigation about gBRCAm. In addition, histological classification shall be conducted based on the resected tumor tissues.

Eligibility Criteria:
Inclusion Criteria:

For registration to this study, all of the following criteria should be satisfied:

1. The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature.
2. Female Japanese at more than 20 years of age
3. The newly diagnosed patients whose epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer is histologically confirmed as FIGO from the subject to obtain their utmost understandings. Limited to histopathological diagnosis based on resected tumor specimens (except the cytodiagnosis by ascites paracentesis).
4. The histopathological specimens can be submitted to the central pathological judgment.
5. Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, the patient's written consent has been obtained.

Exclusion Criteria:

* The subjects who coincide any of the following exclusion criteria are designated to be ineligible:

  1. In case of the subjects who are diagnosed to have acute or chronic physical or severe mental diseases except cancer, and about whom the attending responsible physician makes judgement to say that participation of these subjects would possibly increase the risks or would probably disturb the interpretation of the study results.
  2. In case of the subjects whose registration for the study is judged by the attending responsible physician as inappropriate.