cyrilzakka/clinical-trials huggingface dataset:
Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Study hypotheses is that Antiparasitic therapy in patients with chronic diarrhea after travel to a developing country, with a negative stool findings, will be significantly effective in eliminating diarrhea and other gastro-intestinal complaints compared to similar patients receiving placebo.

It is common to encounter travelers from developing countries who suffer from persistent diarrhea after returning home. In many cases repeated stool samples are negative for bacteria, parasites and helminthes and the cause of the diarrhea is not found.

The main debate is whether this condition is a persistent parasitic infection (unidentified) or post-infectious irritable bowel syndrome.However, clinical experience suggests that some of these travelers respond to antiparasitic therapy.

This study aims to answer the question whether antiparasitic treatment in these cases is beneficial.

Eligibility Criteria:
Inclusion Criteria:

* Diarrhea (3 or more soft stools per day) for at least two weeks after a trip to a developing country in the past year
* Stool sample negative for bacteria, parasites and helminthes at least once
* Has not received, until now, antiparasitic or antihelminthic therapy

Exclusion Criteria:

* Bloody diarrhea
* Fever during enrolment 5. Allergy to the offered medication
Ischemic Postconditioning in Carotid Surgery

Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT).

Eversion carotid endarterectomy (eCEA) has proven effective in preventing ischemic brain damage resulting from atherosclerotic disease in the extracranial segment of the carotid arteries. Over time, advancements in surgical techniques have led to a reduction in the incidence of perioperative stroke. To better understand the concept of stroke complications following CEA, a clear distinction between intraprocedural and postprocedural strokes is necessary. Periprocedural strokes are attributed to hypoperfusion or embolization from the site of endarterectomy, while defined causes of postprocedural strokes include local carotid artery thrombosis or cerebral hyperperfusion syndrome (CHS).

CHS, occurring in 1-3% of cases, is a potentially catastrophic event following eCEA, primarily resulting from impaired autoregulation mechanisms and post-revascularization changes in cerebral hemodynamics. Patients with significant carotid stenosis are particularly vulnerable to CHS due to prolonged cerebral hypoperfusion, where collateral circulation serves as a protective mechanism. Another pathway leading to CHS involves increased free radical concentrations, damaging the blood-brain barrier. Identified risk factors for CHS development include advanced age, prior ischemic cerebrovascular events, and contralateral stenosis \> 70%.

Various methods for predicting CHS development and collateral circulation insufficiency include cerebral oximetry, transcranial Doppler sonography, perfusion computed tomography, and quantitative magnetic resonance imaging. Cerebral oximetry, with real-time detection of cerebral oxygenated hemoglobin saturation, exhibits promising sensitivity and specificity in predicting CHS occurrence.

Analyzing changes in biomarkers of neuronal ischemic injury and blood-brain barrier integrity offers insight into CHS pathophysiology and indirectly assesses the safety and efficacy of ischemic postconditioning of the carotid artery (IPCT) in high-risk patients. IPCT, shown to have a protective effect in animal models, recently demonstrated encouraging results in human trials.

Utilizing intraoperative neuromonitoring with cerebral oximetry and transcranial Doppler enables real-time monitoring of cerebral oxygenated hemoglobin saturation and flow characteristics during and after IPCT, validating its protective effect and safety in high-risk CHS scenarios.

Eligibility Criteria:
Inclusion Criteria:

* unilateral carotid artery stenosis \>90%
* bilateral stenosis \>80%
* unilateral stenosis \>80% with contralateral occlusion/subocclusion

Exclusion Criteria:

* urgent carotid endarterectomy
* carotid restenosis
* "major surgery" in the last 6 months
* malignant diseases
* previous brain trauma or surgery
* epilepsy
Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.

Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis.

The primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition

Exclusion Criteria:

* Metabolic disease
* Chronic kidney or liver failure
* Shock
* Contraindications for lipid administration
* PN during the 15 days before hospitalisation
Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke

The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function, and quality of life among stroke patients during the 8 weeks of application (Time 1: Baseline, Time 2: Week 4, Time 3: Week 8).


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 80 years of age
* Within 1-12 months of ischemic or hemorrhagic stroke
* First onset resulting in hemiparesis of a limb with Burnnstrom stage of 3, 4 or 5
* Modified Ashworth Scale with scores of less than or equal 2 for elbow, wrist, and hand muscle tone in the affected upper extremity
* Able to understand instruction

Exclusion Criteria:

* Serious cardiovascular or respiratory diseases
* Skin lesions, infections or other skin problems
* Serious circulatory problems such as deep vein thrombosis
* Allergies or significant discomfort to pressure garment materials
* Upper extremity fractures or severe joint problems
* Severe cognitive impairment with Saint Louis University Mental Status (SLUMs) scores equal to or less than 27 (above high school level of education)/25 (below high school level of education)
Induction-maintenance of Lopinavir/r in HIV-infected Subjects

This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.

The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1.

Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.


Eligibility Criteria:
Inclusion Criteria:

* Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the trial that are relevant to his or her decision to take part, by signing and dating the IRB / IEC approved informed consent form.
* Subject is HIV positive and on their first antiretroviral treatment regimen, based on any two NRTIs plus lopinavir/ritonavir or a ritonavir-boosted PI combination. Subject must have had no previous exposure to other regimens.
* Subject has a viral load \<50 copies/ml at the time of baseline evaluation for at least 6 months.
* Subject has a CD4 cell count ³ 100 cells/mm3.
* Subject is aged \>18 years.
* Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
* Subject has not been treated for an active opportunistic infection within 30 days of screening.
* If female, subject has a negative pregnancy test and agrees to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
* Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with any of the antiretroviral drugs in their treatment regimen. The subject agrees not to take any medication, including over-the-counter medicine, alcohol, or recreational drugs without the knowledge and permission of the principal investigator

Exclusion Criteria:

* Subject has current uncontrolled substance abuse or psychiatric illness that could preclude compliance with the protocol.
* Subject has a viral load of \> 50 copies/ml
* Subject is HBsAg +
* Subject has active tuberculosis or an opportunistic infection.
* Subject has active malignancy (except Kaposi's Sarcoma).
* Subject has liver failure as evidenced by ALT / AST \> 5 x Upper Limit of Normal (ULN).
* Female subject is pregnant or lactating.
* Subject has received an investigational drug within 30 days prior to the initiation of the study.
* Subject has modified his/her antiretroviral therapy during the 3 months prior to baseline or is intending to do so during the course of the study.
Different Stimuli of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia

To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases by Jingluo (the system of meridians, through which energy is thought to ﬂow through the body in Chinese medicine). It is usually applied to relieve pain. Several clinical trials have been conducted to evaluate the effect of electroacupuncture on the consumption of intra-operative anaesthetics and on drug-related side-effects, with promising results. Compared with acupuncture or electroacupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique and has some advantages, including no risk of infections or needle-induced contagious disease and reduced fear of stimulation. It can potentially be applied by any anaesthetist or pre-operative personnel with minimal training.Thus, investigators conducted this controlled, prospective, double-blinded clinical trial to investigate whether treating by transcutaneous electrical acupoint stimulation combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 65
2. ASA physical statusⅠorⅡ
3. Elective gynecological laparoscopic surgery under general anesthesia
4. BMI of 18 to 25
5. Duration of operation≤2 hours
6. Patient who signed the informed consent

Exclusion Criteria:

1. Pregnancy or breast-feeding women
2. Serious lung disease/Serious cardiovascular disease/Serious liver, renal abnormalities
3. Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease
4. Patient has diseases in nervous-mental system
5. Operation time more than 2 hours
6. Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints;
7. Patients with experience of transcutaneous electrical stimulation treatment.
Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer

This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer
* Has limited-stage disease (stage Tx, T1-T4, N0-3, M0; AJCC staging, 8th edition), and can be safely treated with definitive radiation doses.
* Participant has not received any prior treatment for LS-SCLC.
* Participant has measurable disease as assessed according to RECIST v1.1 that is appropriate for selection as a target lesion for repeat measurement, as determined by local site investigator/radiology review
* ECOG Performance Status ≤ 2 assessed within 7 days before the first administration of study intervention, and must have a life expectancy of ≥ 12 weeks.

Key Exclusion Criteria:

* Mixed small cell lung cancer histology. Note: mixed SCLC with the component of neuroendocrine carcinoma origin is considered eligible
* Have received surgical resection for LS-SCLC
* Any participant for whom the tumor is considered resectable by surgery or stereotactic body radiation therapy/stereotactic ablative radiotherapy should be considered ineligible
* Is expected to require any other form of antineoplastic therapy while on study.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

Note: Other protocol-defined Inclusion/Exclusion criteria may apply
A Trial on the Use of Point-of-care Ultrasound in the Assessment of Breast Symptoms

The high cost of diagnostic equipment, limited expertise, and inadequate infrastructure are major barriers to early breast cancer diagnosis in low- and middle-income countries. Point-of-care ultrasound (POCUS) offers a relatively low-cost, portable solution that, when combined with artificial intelligence (AI)-driven image analysis, has the potential to significantly expand access to breast assessment in these settings. The purpose of this study is to evaluate the performance of POCUS for women with focal breast symptoms and to assess the performance of AI to analyze POCUS images. The study will be divided in two parts: a prospective interventional study and a retrospective multicase multireader study.

In this trial we want to understand if the use of POCUS is non-inferior to Standard of Care (SoC) and if the combination of POCUS AI can reach non-inferior performance to that of breast radiologists. There is a need for breast diagnostic tools in underserved countries since late-stage diagnosis is a major cause of the high breast-cancer mortality in low-and middle-income countries. Showing that POCUS can be sufficient for an assessment of focal breast symptoms can provide evidence for a broader use. Also, enabling automated interpretation using AI can add to the value of this low-cost and accessible solution. The first part of the trial is a prospective open-label accuracy study with paired design. The intervention of POCUS as a targeted diagnostic method for women with focal breast complaints will be compared with SoC. We will also be able to compare POCUS with the individual components of SoC (mammography and standard ultrasound) and retrospectively with POCUS AI. The second part of the trial is a single-blinded retrospective paired mulitcase multireader study. In this part we can directly assess POCUS and POCUS AI without the influence of mammography and benchmark to a larger group of radiologists and in addition compare with standard ultrasound

Eligibility Criteria:
Inclusion Criteria:

* Women (≥18 years of age) referred to diagnostic imaging with a suspicion on malignancy

Exclusion Criteria:

* Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer

This study will utilize Rasch analysis to study the construct validity and reliability of five shoulder-related patient-reported outcome measures in patients reporting shoulder impairment following surgery for head and neck cancer.

This study is a cross-sectional, questionnaire-based psychometric study. The purpose of the study is to: (1) use Rasch methodology to assess the reliability, construct validity, and overall appropriateness of test score interpretation of 5 shoulder-related patient reported outcome measures in patients experiencing shoulder dysfunction following neck dissection surgery for head and neck cancer; and (2) based on these findings, provide recommendations of which patient reported outcome measure or combination of measures most accurately reflects shoulder disability in patients who experience shoulder dysfunction following neck dissection surgery. Two-hundred and fifty subjects will be recruited during regularly scheduled clinical visits at Mayo Clinic. Subjects will complete five shoulder-related patient reported outcome measures on only one occasion, therefore subjects will be responsible for study participation only at the time of enrollment and same day completion of study-related documents. Upon the conclusion of data collection, Rasch analysis will be utilized to analyze data related to the research objectives, and descriptive statistics will be utilized to describe the sample.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral neck dissection procedure for management of head and neck cancer within the past 2 weeks to 18 months
* Endorse some level of shoulder impairment (Answer "yes" when asked "are you currently experiencing any shoulder weakness or discomfort as a result of your surgery?")
* 18-90 years of age
* Adequate fluency in the English language to complete the study-related forms and questionnaires

Exclusion Criteria:

• No reported shoulder impairment
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment

Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.

This is a Phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of renal impairment. The study is conducted in 2 parts: the Pharmacokinetic Part (Cycle 1) and the Extension Part (Cycles 2 and beyond). Patients may continue to receive treatment with TAS-102 during the study extension part only after completion of the Pharmacokinetic Part.

Eligibility Criteria:
Inclusion

1. Has provided written informed consent
2. Has advanced solid tumors (excluding breast cancer)
3. Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis
4. ECOG performance status of ≤2
5. Is able to take medications orally
6. Has adequate organ function
7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion

1. Certain serious illnesses or medical condition(s)
2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
3. Has received TAS-102
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Is a pregnant or lactating female
Online Mindfulness Training Versus Health Education for Fibromyalgia

The purpose of this study is to compare an online 12-module intervention designed to improve emotion regulation and social relations via mindfulness training with a 12-module program that provides information about health behaviors to individuals with fibromyalgia. The mindfulness training program is expected to produce greater day-to-day improvements than the education condition in individuals' efficacy for coping with pain and stress, positive and negative affect, and positive engagement in social relations assessed via online diaries completed each evening during the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Self-report of physician diagnosis of fibromyalgia
* Able to read and understand English
* Daily access to the internet

Exclusion Criteria:

* Self-report of more than 5 past episodes of depression
Rerouting Seton Versus LIFT for Complex Anal Fistula

This study aims to compare the efﬁcacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female

Exclusion Criteria:

* Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas.
* ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients
* Patient with any grade of anal incontinence.
* Patients with concomitant anal pathology.