cyrilzakka/clinical-trials huggingface dataset:
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement

The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery.

The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). To reduce potential confounding by differences in implanted valve prostheses, in both arms of the trail, the diseased native aortic valve is planned to be replaced with a rapid deployment stented aortic bioprosthesis (Edwards Intuity Elite Valve System®, Edwards Lifesciences Corporation), the preferred type of valve prosthesis for a limited access approach. Patients will be randomized 1:1 to both arms with 80 patients per arm. Patients who are unwilling or unable to participate in the randomized study will be treated via conventional median sternotomy with a sutured aortic valve prosthesis and participate in a prospective registry.

Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36 (SF-36), postoperative pain, perioperative outcome (i.e. technical success rate, operating time) and postoperative outcome (i.e. 30 day and one-year mortality, complication rate, hospital length of stay, reoperation rate and readmission rate). Questionnaires are administered face to face or by telephone prior to surgery and at one, three, six and twelve months after surgery. In the prospective registry the quality of life questionnaires and all clinical data from the patients will be collected and analyzed the exact same way as the data from patients included and randomized in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an isolated biological aortic valve replacement for a severe and/or symptomatic aortic valve stenosis, defined as:

  * An aortic valve area of ≤1.0cm2, and;
  * Mean valve gradient ≥40mmHg, and/or;
  * A peak velocity of at least 4.0m/s.
* Able to understand the nature of the study and what will be required of them;
* All adult men and non-pregnant women;
* BMI between 18-35.

Exclusion Criteria:

* Inability to give written informed consent;
* Inability to adequately answer the questionnaires;
* Patients requiring additional cardiac surgery during the same procedure;
* Patients requiring a reoperation;
* (relative) contraindications for a limited access approach;
* Undergoing an emergency operation;
* Recent myocardial infarction (\<90 days);
* Recent stroke or transient ischemic attack (\<6 months);
Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis

The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved gastric adenocarcinoma.
* Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid.
* Potentially resectable gastric cancer.
* ALT, AST \< 80U/L; Total Bilirubin \< 30μmol/L; WBC \> 4x10\^9/L; PLT \> 100x10\^9/L; Cr \< 1.5 fold normal value.
* ECOG 0-2 points.
* Expected survival time longer than 3 months.
* Informed consent.

Exclusion Criteria:

* Recurrent gastric cancer.
* Pregnant or lactating women.
* Allergic to oxaliplatin or paclitaxel.
* Abnormal liver/kidney function.
* Serious heart/metabolic disease.
Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases

The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
* Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
* No other metastases except for brain metastases.

Exclusion Criteria:

* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Open Label Trial of Nissle 1917

Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat gastrointestinal disorders and infections. The investigators will assess the safety and tolerability of this medication in Americans in a Phase 1 trial.

Background: Nissle 1917 is an E. coli based probiotic that has been successfully used in Europe for close to 100 years to treat largely gastrointestinal disorders like inflammatory bowel disease, gastroenteritis, and irritable bowel syndrome. In addition to those disorders, we believe that Nissle 1917 is a promising alternative therapy for prevention of urinary tract infections in susceptible individuals.

Purpose: The Phase 1 trial will use Nissle 1917 in healthy adult patient volunteers for the first time in the United States. The investigators will track the frequency and incidence of side effects and adverse events.

Participants:

20 adult (\>21 years of age) healthy volunteers

Protocol:

* Participants will enroll in our trial after a review of medical history and physical.
* Participants will then take 30 day course of Nissle 1917 capsules
* Investigators will telephone participants 1-2 weeks after they have begun the trial to assess for any side effects or adverse events
* Subjects will also be provided with a diary to record any side effects or adverse events
* At the end of 30 days, participants will return to clinic for a follow up visit to discuss any side effects or adverse events experienced during the trial and to return any unused medication
* Investigators will again telephone all participants 28-35 days following completion of the study drug again to pose a questionnaire aimed at revealing any side effects or adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteer of age 21 years or older

Exclusion Criteria:

* Any individual with an active urinary tract infection (UTI)
* Any individual with an acute illness within the past 7 days
* Any individual with neurogenic bladder or with vesicoureteral reflux
* Any individual with any anatomic abnormality, congenital or acquired, of the urinary tract system
* Any individual with any anatomic abnormality, congenital or acquired, of the gastrointestinal tract
* Any individual with untreated dysfunctional elimination syndrome
* Immunocompromised patients
* Individuals with a central venous catheter
* Individuals requiring the use of antibiotics, immunomodulatory medications, or other probiotics
* Any participant with a history of chronic gastrointestinal disease
* Any individual with a chronic uncontrolled medical illness
* Any female of reproductive age who is currently pregnant, breastfeeding, or sexually active and unwilling or unable to use an acceptable method of contraception.
* Any participant is unable to appropriately take and store medication
* Any individual enrolled in a clinical trial evaluating another investigational agent in the last 30 days.
Clinical Study on the Combination of Xiaoyu Zhitong Formula and Lymphatic Drainage Technique to Improve the Symptoms of Knee Pain and Swelling in Cold Dampness Obstruction Type

This research project applies a combination of blood stasis relieving and pain relieving formula and lymphatic drainage technique to treat patients with cold dampness obstruction type knee joint pain. The improvement of knee joint pain scores and activity function as well as the degree of soft tissue swelling changes are observed before and after receiving this therapy providing certain ideas for the comprehensive treatment optimization and prognosis judgment of cold dampness obstruction type knee joint pain.


Eligibility Criteria:
1. Inclusion Criteria:

   * a. Patients who meet the diagnostic criteria for knee osteoarthritis in the "Guidelines for Diagnosis and Treatment of Osteoarthritis" (2007 edition) of the Chinese Medical Association Orthopedic Branch and also meet the diagnostic criteria for wind cold dampness syndrome of knee joint obstruction;
   * b. Age range: 25-70 years old;
   * c.1 week ≤ disease duration ≤ 2 years;
   * d. If other treatments have already been received and there is a washout period of more than 14 days;
   * e. Voluntarily participate in the study and sign an informed consent form.
2. Exclusion Criteria:

   * a. Patients with bleeding tendencies severe skin damage or skin diseases in certain areas;
   * b. Suspected or diagnosed with tumors;
   * c. Patients with severe heart lung brain diseases tuberculosis osteomyelitis and osteoporosis;
   * d. Patients with mental illnesses;
   * e. Pregnant or planned pregnant women and lactating women;
   * f. Have participated in other clinical studies within the past 3 months;
   * g. The researchers believe that they are not suitable to participate in this clinical study due to other reasons.
Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment

The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 Hepatitis C coinfected adult patients
* Hepatitis C treatment naive
* Stable HIV-1 infection with or without cART
* \> 300 CD4+ cell count

Exclusion Criteria:

* Decompensated liver disease
* Ongoing depression
* Ongoing drug abuse
* Other contraindications for interferon or ribavirin treatment
A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers

This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also investigate drug interaction between separate and combination administration.

Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day administration, 10 days washout after 5th day of administration.

All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each period.


Eligibility Criteria:
Inclusion Criteria:

* 20\~50 yrs old, healthy Korean Subjects
* Body weight \<ideal body weight±20%
* No congenital, chronic disease, No current disease
* Subjects who are diagnosed to include by medical doctor from laboratory and ECG result.
* Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
* Subjects who have taken other medicine in recent 2\~4 weeks.
* Subjects who have a risk of hypoglycemia and imbalance in taking a diet.
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients.

FMT includes both colonoscopy and stool capsules.

This is a phase I single-center study of fecal microbiota transplant (FMT) in melanoma patients who failed at least one line of PD-1 blockade.

Eligible patients must have a disease amenable to biopsy and lack of contra-indications to FMT.

Patients will undergo a baseline evaluation including imaging, tumor biopsy, blood samples and stool studies to confirm suitability for the study.

Eligible patients will undergo FMT. The FMT includes a colonoscopy followed by stool capsules.

Patients will undergo repeated evaluations including follow-up blood, stool and radiological testings.

The study will be conducted over a 24-week period.

Eligibility Criteria:
Inclusion Criteria:

* A histologically confirmed diagnosis of metastatic melanoma.
* Failed at least one line of PD-1 blockade.
* ECOG Performance Status 0-2
* Able to provide written informed consent.

Exclusion Criteria:

* Presence of absolute contra-indications to FMT administration.
* Severe dietary allergies (e.g. shellfish, nuts, seafood).
* Anatomic contra-indications to colonoscopy.
* Inability to swallow capsules.
* Current participation in a study of an investigational agent.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment.
* History of bleeding disorder, chronic kidney disease, Inflammatory bowel disease.
* History of a major abdominal surgery
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery

In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.

Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.

The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.

The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo major surgery
* Patients monitored by a Pulsioflex® device

Exclusion Criteria:

* Patients with heart rhythm disorder
* Patients with Raynaud's disease or vasculitis
* Emergency surgery
* Significant edema fingers
Internet-based Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)

Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder (OCD) but there is a lack of properly trained CBT therapists. One possible treatment alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study was therefore to evaluate ICBT for OCD.

This is a randomized controlled trial with 101 participants. The control group receives support therapy on demand on the Internet.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of obsessive compulsive disorder (OCD)
* At least 18 years old
* Able to read and write in swedish
* Computer access

Exclusion Criteria:

* other primary diagnosis
* substance abuse,
* psychosis,
* bipolar disorder,
* suicidal ideation,
* adjusted pharmacological treatment the last two months
* current psychological treatment for OCD,
* been treated with CBT the last two years,
* serious somatic disease,
* Y---BOCS\>31
* hoarding as primary OCD subtype
Safety and Efficacy Predimenol for Headache

This is a prospective, double-blind, placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of Predimenol in alleviating headache.

Predimenol is a bioactive fraction extracted from Phaleria macrocarpa pericarpium (Mahkota Dewa).

There will be 20 subjects per group (a total of 60 subjects) planned to be enrolled in the study.

The investigational drug: tablet @200 mg of Predimenol. Dose administration: one singe dose (two tablets) of Predimenol or Placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache.
2. Signing the informed consent.

Exclusion Criteria:

1. Body temperature of \>37.3˚C and/or refuse to follow health protocol for COVID-19.
2. Known hypersensitivity to herbal drugs.
3. Pregnant or lactating women.
4. Have received any analgesic or anti-inflammatory drugs within the past 12 hours.
5. Presence of vomiting or diarrhea within the past 24 hours or still ongoing at the start of study.
6. Severe illness, e.g. severe hypertension, or any known organic diseases that may cause headache.
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

Management of participants with low-level persistent viremia

ANRS 161 L-Vir is a phase III prospective, randomized, multicenter, open-label, superiority trial for participants with low-level persistent viremia.

Participants will be randomized with a 1:1:1 ratio to the following three arms,

* Reference arm : counseling without antiretroviral treatment modification
* Switch arm : switch of current PI/r for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
* Addition of Isentress® (raltégravir) arm : Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* HIV-1 infection
* On combined antiretroviral regimen for at least 18 months
* Participant with a stable antiretroviral regimen for at least 6 months, including 2 Reverse-transcriptase inhibitor (INTI) + 1 Boosted Protease Inhibitor IP/r ,
* participant with at least 2 consecutive viral load between 50 and 500 copies/milliliter over the last 9 months (with at least 2 months between the two measurements) quantified with the same commercial kit.
* 50 \<or= VL \< 500 copies/milliliter at screening visit quantified with the same commercial kit than previous one.
* Participant naïve to raltegravir (RAL)
* failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation)
* creatinin \< 3 Upper Limit normal (ULN)
* Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) \< 5 Upper Limit normal (ULN)
* hemoglobin \> 8 g/dL
* platelets \> 50 000/mm3
* In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (βHCG) at week -4 visit and use of a mechanical contraceptive method
* Informed consent
* Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique)

Exclusion Criteria:

* HIV-2 infection,
* severe medical condition in the last month (inclusion is possible for a stable condition at screening)
* breastfeeding women, current pregnancy or planned pregnancy within 12 months.
* participant currently receiving Prezista® (darunavir)/ Norvir® (ritonavir) (600/100 mg) two times a day (BID) (of note, participants receiving Prezista® (darunavir)/ Norvir® (ritonavir) one time a day (QD) can be included)
* Hypersensitivity Prezista® (darunavir)/ Norvir® (ritonavir) or to any of the excipients of the study treatment
* participant under judicial protection (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
* planned absence that could prevent the patient from participating in the trial (travel abroad, moving, pending work transfer ...)
Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1

The ability of an individual to conceive some alternative representations and to behave in a flexible manner would emerge from preschool age and drastically improve between the ages of 3 and 5 (Doebel and Zelazo, 2013). They constitute, according to Diamond (2013), a prerequisite for the development of the Theory of Mind (ToM). Deficits in Executive Functions (EF) may therefore interfere with the child's ability to understand and adapt to social situations.

Treatment failures are often observed when traditional cognitive tools are used. This would be linked to the divergence between non-immersive tests and situations encountered in everyday life (Damasio, 1994; Priore Castelnuovo and Liccione, 2002). For this reason, an increasing number of researchers are using virtual reality for the rehabilitation of executive functions and Theory of Mind in patients with neurodevelopmental pathology (Millen, Edlin-White and Cobb, 2010) or brain damage (Le Gall, Besnard, Louisy, Richard and Allain 2008). There is currently no systematic evaluation of ToM in children with the infantile form of DM1 even though these abilities are considered particularly vulnerable and have a decisive impact on the subsequent development of interpersonal relationships.

This research will focus on studying the socio-emotional disorders associated with the infantile form of Myotonic Dystrophy type 1 (DM1). The axis that we propose to develop more specifically will be an interventional study with the aim of remediation with children from 5 to 16 years old suffering from the infantile form of DM1 via a training protocol in low-immersion Virtual Reality (VR) centered on emotional processing and theory of mind.


Eligibility Criteria:
Inclusion Criteria:

* 6 years and \< 16 years of age
* Written informed consent
* Affiliate or beneficiary of a social security scheme
* Able to comply with all protocol requirements
* Infantile form of DM1 with molecular confirmation.
* Development without incident in the first year
* Normal development in the pre and neonatal period
* Native language French

Exclusion Criteria:

* Unable to participate in the study
* Inability to comply with protocol requirements
* Congenital form of DM1
* IQ\<70 (Intellectual Disability)