cyrilzakka/clinical-trials huggingface dataset:
Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

The purpose of this study is to determine whether therapy that has been shown to be beneficial for mitochondrial diseases is also beneficial for Chronic Fatigue Syndrome (CFS) patients. This study is a chart review of previous CFS patients who received daily conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed nutraceutical supplements included alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin.

Twelve CFS male and female patients between the ages of 20-70 years will be recruited to participate in this pilot study. Subjects will be eligible to participate if they meet the criteria for CFS of the Centers for Disease Control and Prevention (CDC). These include persistent, unexplained fatigue for at least 6 months, concurrent with four of the following: impaired memory/concentration, sore throat, new headaches, unrefreshing sleep, muscle pain, multi-joint pain, tender lymph nodes, and post-exertional malaise.

The etiology and pathogenesis of chronic fatigue syndrome (CFS) is poorly understood. Although therapies have been proposed, none has been particularly effective. A preceding viral infection is believed to cause mitochondrial dysfunction in genetically susceptible individuals, resulting in overwhelming fatigue, myalgia and brain fuzziness. The purpose of this study was to determine whether therapy that has been shown to be beneficial for mitochondrial diseases is also beneficial for CFS.

Patients received daily conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed nutraceutical supplements incldued alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin, which were selected to enhance mitochondrial function and antioxidant action. Following the institution of ENT, patients had received this therapy for varying lengths of time, ranging from 12 to 40 months.

Eligibility Criteria:
Inclusion Criteria:

Severe chronic fatigue for 6 or more consecutive months 4 or more of the following 8 symptoms concurrently:

* post-exertion malaise lasting more than 24 hours
* unrefreshing sleep
* significant impairment of short-term memory or concentration
* muscle pain
* pain in the joints without swelling or redness
* headaches of a new type, pattern, or severity
* tender lymph nodes in the neck or armpit
* a sore throat that is frequent or recurring These symptoms should have persisted or recurred during 6 or more consecutive months of illness and they cannot have first appeared before the fatigue.

Exclusion Criteria:

* Additional medical illnesses causing chronic fatigue
* Ongoing exertion
Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

this study evaluates the addition of initial short term NSAID treatment to physiotherapy prescribed exercise treatment in patient with early phase tendinopathy. Half of the participants will initially receive NSAID (naproxen) for 7 days, while the other half will receive a placebo, where after both groups will be subjected to 3 months heavy slow resistance training.

NSAID is effective in short term pain relief in musculoskeletal disorders, but little is known about the long-term effect in early phase tendinopathy, when used as a supplement to treatment as usual, namely heavy slow resistance training and training load reduction. In this study, NSAIDs will be used, which works through COX inhibition, which again inhibits Prostaglandins, in this way investigators attempt to dampen the initial inflammation and pronounced cell activity that is thought to be present in early phase tendinopathy. With this project, it will be attempted to investigate whether initial dampening adds to the effect achieved through heavy load resistance training, which is thought to stimulate structural repair and regeneration in the tendon, by applying appropriate load to the tendon tissue, thereby stimulating the tendon cells to repair and regeneration.

Eligibility Criteria:
Inclusion Criteria:

* Activity related pain in the achilles tendon
* Palpation pain in the achilles tendon
* Onset of symptoms within the last 3 months

Exclusion Criteria:

* Previous injury in the achilles tendon on the ipsilateral side.
* Recent infection around the achilles tendon
* Previous surgery in the achilles tendon.
* Contraindications for NSAID treatment.
* NSAID treatment for the current injury
* Medication with NSAID interaction
Assessment of Fatty Liver with Thermo-acoustic Device

The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.

Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed or suspected to have non-alcoholic fatty liver disease
* Patients 18-70 years of age
* be able to understand and sign on written informed consent
* able to undergo ultrasound and MRI examinations

Exclusion Criteria:

* any metal or electronic implants including but not limited to pacemakers, clips, hips
* known history of pregnancy or becoming pregnant during study period
* unable to understand and sign on written informed consent
* intolerant to ultrasound and/or MRI examinations
Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies

ARQ 092 is being investigated for patients with overgrowth diseases and/or vascular anomalies with genetic alterations of the PI3K/AKT pathway and may be available for patients who are ineligible for an ongoing ARQ 092 clinical trial or have other considerations that prevent access to ARQ 092 through an existing clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Severe overgrowth diseases and/or vascular anomalies with confirmed somatic genetic alterations of PIK3CA or AKT
2. Are unable to participate in an ongoing ARQ 092 clinical trial
3. Willing and able to provide written, signed informed consent. In the case of a minor, a parent or legal guardian must sign an informed consent form.
4. Medically suitable for treatment with ARQ 092
5. Not eligible for any other available therapy for the diagnosed overgrowth disease and/or vascular anomaly with confirmed somatic genetic alterations of PIK3CA or AKT

Exclusion Criteria:

1. Currently enrolled in an ongoing clinical study of ARQ 092 or other investigational drug
2. Currently being treated with any inhibitor of the PI3K/AKT/mTOR pathway
Knowledge Base in the Treatment of Atopic Dermatitis Among Thai Pediatricians

The purpose of this study is to determine knowledge base in diagnosis, investigation and treatment of pediatric atopic dermatitis among thai pediatricians.

Background: Currently, there is no existing information regarding prescribing practices for the management of childhood atopic dermatitis among pediatricians in Thailand.

Objective: In order to learn about basic knowledge, natural history, evaluation, diagnosis, treatment and prevention for childhood atopic dermatitis in Thailand

Methods: 900 self-administered questionnaires were randomly mailed to pediatricians throughout Thailand, asking about their preferences in the management of childhood atopic dermatitis. One hundred and eighty-five of these 900 questionnaires were returned (a response rate of 20.6%)

Eligibility Criteria:
Inclusion Criteria:

* All pediatricians who're working in thailand including sub-board pediatricians.
Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients

Right ventricular failure (RVF) is an independent factor of mortality for many pulmonary diseases. Currently, RVF is defined as the incapacity of the RV to maintain the flow without dilating to use the Frank-Starling law (i.e., increase of the ejection volume associated to an increase of the preload). RVF is associated to RV systolic dysfunction which is conventionally defined as a decrease of the RV ejection fraction (RVEF) \< 45%.

In the intensive care unit (ICU), acute RVF is mainly due to the acute respiratory distress syndrome (ARDS), sepsis or septic shock, and less often to severe pulmonary embolism or RV infarction.

The anatomical complexity of the RV precludes any geometrical assumption to estimate its volume, hence its ejection fraction (EF) using two-dimensional (2D) echocardiography. For this reason, the evaluation of RV systolic function is currently based on parameters used as surrogates of RVEF: fraction area change in 2D-mode, tricuspid annular plane systolic excursion (TAPSE) in M-mode, and maximal velocity of the systolic S' wave using tissue Doppler imaging.

Real-time three-dimensional (3D) echocardiography now enables accurate on-line measurement of RV volume and provides at the bedside the non-invasive assessment of RVEF. 3D transthoracic echocardiography (TTE) has been validated to measure RV volume and RVEF compared to MRI which is the gold standard. However, 3D transesophageal echocardiography (TEE) has not yet been validated in this specific clinical setting, while 2D TEE is frequently used in ICU in ventilated and sedated patients. Accordingly, the diagnostic ability of 3D echocardiography to quantify RV systolic function in ICU patients with RVF of any origin is currently unknown.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥ 18 years old) hospitalized in the ICU and requiring echocardiography for any reason
2. With a disease at risk of being associated with RVF:

   * ARDS (Berlin definition)
   * Sepsis or septic shock (Sepsis-3 definition)
   * Pulmonary embolism
   * RV infarction
3. Affiliated to Social Security
4. Consent of the patient and/or his authorized representative to participate in the study.

Exclusion Criteria:

1. History of congenital cardiac disease
2. Patient under legal protection
3. Under any method of oxygen support or extracorporeal circulatory support (veno-venous extracorporeal membrane oxygenation, extracorporeal Life support...)
4. Non sinusal rhythm
5. Documented preexisting right cardiac disease
6. Quality of echocardiographic images incompatible with 3D assessment.
Vigabatrin for the Treatment of Cocaine Dependency

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

There are 3 Phases to this study:

* a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested;
* a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and
* a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study and provide written informed consent.
* Male or female at least 18 years of age.
* Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual-IV (DSM-IV) module.
* Have a verifiable place of primary residence.
* Seeking treatment for cocaine dependence.
* Be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings.
* If female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (IUD), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable.

Exclusion Criteria:

* Please contact site for more information
Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy

Chemotherapy induced nausea and vomiting are common adverse events related to oncologic treatments. It can have deleterious effect on patients' quality of life and could lead to dose reductions and/or discontinuation of treatment. This study aims to quantify the prevalence of nausea and vomiting induced by highly emetogenic chemotherapy in patients who had adequate antiemetic prophylaxis, also to describe the epidemiologic profile and identify predisposing factors.

The investigators will track patients in the first and second cycles of chemotherapy. Information regarding comorbidities, medical history and sociodemographic characteristics will be collected. The impact of nausea and vomiting induced by the treatment on patient's quality of life will be evaluated using the questionnaire Functional Living Index-Emesis - FLIE.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological confirmation of cancer;
* Patients who will start chemotherapy with a high-grade emetogenic scheme and who have received adequate antiemetic prophylaxis;
* No previous cancer treatment for the current diagnosis (excluding surgery);

Exclusion Criteria:

* Patients who have an inability to answer the questionnaire, due to lack of discernment to answer the questions reliably;
* Patients who report vomiting during the 24 hours prior to the first cycle of chemotherapy treatment;
* Patients who have a disease or condition that could cause emesis (ie, metastasis in the central nervous system, gastrointestinal obstruction or metabolic and electrolyte imbalances);
* Patients using opioids or illicit drugs;
* Alcoholism;
The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions

The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.

This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. The patient presented a score from 2 to 5 following Rutherford classification.
2. The patient is willing to comply with specified follow-up evaluations at the specified times.
3. The patient is ≥ 18 years old.
4. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
5. The patient has a projected life expectancy of at least 24 months
6. Before enrolment, the guidewire has crossed the target lesion
7. Subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (CTO) length ≥15cm.
8. There is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot.
9. Origin and proximal 1 cm of Superficial Femoral Artery (SFA) are patent.
10. Reference vessel diameter (RVD) ≥ 4 mm by visual estimation.

Exclusion Criteria:

1. Previous bypass surgery or stenting in the target vessel
2. Patients who exhibit acute intraluminal thrombus at the target lesion vessel
3. Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
4. Pregnant women or Female patients with potential childbearing
5. Use of thrombectomy, atherectomy, or laser devices during the procedure
6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
7. The patient is currently participating in another investigational drug or device study that interferes with the study
8. Significant renal dysfunction (Serum creatinine \>3.0mg/dl)
9. Patient with Known allergy to contrast media
10. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
11. Femoral or popliteal aneurysm.
12. Current peritoneal or hemodialysis.
Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.

This is a randomized, placebo-controlled, multi-center, partially blinded \[i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively\] and placebo, but unblinded for non-adjuvanted IC43 \[i.e., 100 mcg w/o Al(OH)3\] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18 and 80 years
* Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
* At high risk for acquiring infection against P. aeruginosa at visit 0.
* Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
* In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception
* Written informed consent or waiver according to the national regulations

Exclusion Criteria:

* Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0
* Low severity of illness defined by an acute physiology score \< 8 at visit 0
* Patients \< 6 months post organ transplantation
* Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
* Pregnancy, lactation
* Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
Attention Training for COVID-19 Related Distress

The study aims to test whether attention training (attention bias modification or attention control training) reduces distress or COVID-19 related anxiety compared to a neutral condition.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 Anxiety Syndrome Scale \> 7 and/or COVID-19 related loss

Exclusion Criteria:

* Does not speak English Fluently
to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.

drug interaction : rosuvastatin, ezetimibe

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects age between 19 and 45 singed informed consent

Exclusion Criteria:

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
CT and Radiologist RCT

The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors.

The researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of CT scans for the presence/absence of a ventral hernia.


Eligibility Criteria:
Participants are radiologists at LBJ Hospital.
Thoracolumber Oterfacial Plane Block for Spine Surgery

The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the use of systemic opioids, Paracetamol, non-steroidal anti-inflammatory drugs (NSAID), steroids and gabapentinoids .

In 2015, a promising regional analgesia technique was reported, that targets the dorsal, rather than ventral, rami of the thoracolumbar nerves as they pass through the paraspinal musculature, and called this a thoracolumbar interfacial plane block (TLIP).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for Spine surgery.

Exclusion Criteria:

* Spine deformities, redo surgeries, patients refusing being enrolled in the study, and patients with a bleeding tendency (INR˃ 1.4 and or Platelet count ≤ 150 X103/ µl) will be excluded.