cyrilzakka/clinical-trials huggingface dataset:
Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country.

The objective of this research is to describe the burden of subclinical anthracycline therapy related cardiac dysfunction( ATRCD) by applying international guideline on Uganda cancer patient and to evaluate the significance of treating subclinical ATRCD with carvedilol.

Specific objectives:

1. To determine the incidence of subclinical ATRCD among cancer patient who receives Anthracycline therapy.
2. To compare the changes of GLS value between hypertension and non hypertension cancer patient at the competition of the anthracycline therapy.
3. To determine the correlation of conventional echocardiograghy(ECHO) parameters (MAPSE, S') with GLS, and their ability to diagnose or rule out subclinical ATRCD.
4. To determine the correlation of oxidative stress with cardiac function(GLS value) in patients who receives Anthracycline therapy
5. To describe the cardioprotective effect of carvedilol in patients with subclinical ATRCD.

METHODS This is going to be two prospective cohort study (cohort 1 and 2) followed by a randomized controlled trial (cohort 3).

To achieve objective 1 ,3 and 4, Cohort 1 will consecutively recruit 300 adult non hypertension cancer patients who are going to receive anthracycline therapy.

To achieve objective 2, Cohort 2 will consecutively recruit 53 adult hypertension cancer patients (group H) and 106 non hypertension controls (group N) who are going to receive anthracycline therapy. Controls will be recruited from cohort 1 by systemic sampling( Choosing the 2nd patients as they are enrolled in cohort 1).

Patient's demographic data, cancer diagnosis, dosage of anthracyclin, past medical history, symptoms, physical examinations, ECG, ECHO and laboratory data will be collected at the baseline. Patient follow up will be performed at the completion of the chemo therapy, and 6month thereafter. Data of symptoms, physical examinations, ECG, ECHO and blood test will be collected at each visit. The end point will be the development of subclinical ATRCD.

To achieve objective 5, patients in Cohort 1, who are diagnosed with Subclinical ATRCD will be recruited into cohort 3 and being randomized into group T(carvedilol treatment group) and group C( control, none treatment group).Systemic randomization will be used in Cohort 3: ever second eligible patient will be recruited in group C. Patients in cohort 3 will be followed up for 6month.

Eligibility Criteria:
Inclusion Criteria:

1. Age between and include 18 and 50 years.
2. Newly diagnosed cancer patients who develop subclinical ATRCD during cardiac follow up.

Exclusion Criteria:

1. Patient who has been taking carvedilol prior to the study
2. Patient who self report to be allergic to carvedilol
3. Systolic blood pressure \< 90mmHg
4. Heart Rate \< 50 beat per minute
5. Patient who is asthmatic or has chronic obstructive lung disease
6. Pregnant woman
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects

The primary objective of this study is to assess the efficacy and safety of TV-1380 \[Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)\] in facilitating abstinence in cocaine-dependent subjects.


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
* Male or female aged 18-60 years (inclusive).
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
* Other criteria apply; please contact the site for more information.

Exclusion Criteria:

* Meet criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, benzodiazepines, or marijuana OR have physiological dependence on alcohol requiring detoxification.
* Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 90 days preceding screening.
* Have one or more severe psychiatric disorders as determined by the Mini International Neuropsychiatric Interview (MINI) such as psychosis, schizophrenia, bipolar disease, major depression, or eating disorders in screening.
* Have one or more major neurologic disorders such as dementia or organic brain disease.
* Have other serious medical illnesses (including but not limited to uncontrolled hypertension, significant heart disease, respiratory disease including asthma, hepatic disease, renal disease, AIDS) or other potentially life threatening or progressive medical illness that may compromise subject safety or study conduct as determined by the site MD.
* Other criteria apply; please contact the site for more information.
Optimal Method of Pain Management in Patients With Multiple Rib Fractures

Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications.

An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.


Eligibility Criteria:
Inclusion criteria:

1. Age ≥ 18 years;
2. Three or more rib fractures;
3. Pain

   1. Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR
   2. Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours;
4. Patient has capacity to provide informed consent, as determined by:

   1. Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD;
   2. GCS 15;
   3. Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD.

Exclusion criteria:

1. Lack capacity to provide informed consent;
2. Intubation at time of enrollment;
3. Contraindications to procedure (e.g. known allergy to local anesthetics).
4. Presence of infection at site of catheter placement;
5. Current use of anticoagulant medication;
6. Known allergy to silver;
7. Inability to obtain informed consent;
8. Body weight \> 300 lbs;
9. Pregnancy;
10. Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease).

All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.
Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>16 years of age
* Dry eye patients
* Subject with history of less than 12 weeks of initial RESTASIS® treatment
* Subject started second trial of RESTASIS® treatment prior to June 1, 2008
* First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment

Exclusion Criteria:

* Patients with Contact Lens Intolerance
* Patients with Ocular Rosacea
Cell Therapy as Treatment for Cerebral Palsy

The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed cases of any type of Cerebral Palsy
* age above 6 months.

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/ Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia.
Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease.

II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and fat-soluble vitamin status in these patients.

PROTOCOL OUTLINE: Objective I: This part of the study is a dose-response study to determine the optimal dose of tauroursodeoxycholic acid (TUDCA). Twenty-four patients are randomized to receive one of three different doses of TUDCA for 3 months.

Objective II: This part of the study is a double-blind crossover study to compare optimized doses of TUDCA with optimized doses of ursodiol in 15 patients stratified according to age (less than 10 vs 10-20 vs more than 20 years). Patients are randomized to receive either TUDCA or ursodiol orally for an initial 3 month period, followed by a 3 month washout period in which no drug is administered. Patients then receive the alternate drug for 3 months.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Cystic fibrosis-associated liver disease, defined by at least one of the following criteria: (1) Documented increase in serum concentrations of any of the liver enzymes (at least once in the preceding year) ALT at least twice normal AST at least 1.5 times normal Alkaline phosphatase at least 1.5 times normal GGT at least 1.5 times normal (2) Persistent hepatomegaly of more than 6 months duration defined by percussed liver span greater than 1 SEM for age (3) Splenomegaly, defined as a palpable spleen greater than 2.0 cm below the left costal margin (4) Abnormalities of ultrasound scan (increased size, dishomogeneous echogenicity, nodular liver, irregular margins, splenomegaly) within 6 months prior to study entry
* Patients enrolled in the first part of the study (objective I) are eligible to participate in the second part (objective II)

--Prior/Concurrent Therapy--

* At least 3 months since prior ursodiol
* At least 3 months since treatment with drug with choleretic properties or effects that influence bile acid metabolism

--Patient Characteristics--

* Hepatic: No decompensated cirrhosis No hepatic neoplasm or cholelithiasis
* Pulmonary: No significantly impaired pulmonary function with FEV1 less than 50%
* Other: At least 15 kg body weight No severely compromised clinical or nutritional state
Salivary Biomarkers for Concussion

Recently, several salivary biomarkers (proteins and nucleic acids) of sport related concussion have been identified in professional athletes. However, their reference values have not been determined with sufficient robustness to enable their employment in concussion diagnostic tests. Toward a proper interpretation of the signal for a reliable diagnostic test, we aim to evaluate the physiological variations as well as the effect of different intensive trainings on the profile of these salivary biomarkers in professional athletes. Data generated form such analysis will help establish a baseline profile for these biomarkers whose change in intensity associated with concussion could be diagnosed in the future.


Eligibility Criteria:
Inclusion Criteria:

* Male participants aged between 18 and 40 years old.
* Participants willing to comply with the study procedures.
* Participants capable of understanding the purpose, nature, and methodology of the study.
* Participants affiliated to a French social security system or beneficiaries of such a system.
* Participants who have signed the non-opposition form to participate in the research.

Non-inclusion Criteria:

* Participant not affiliated to a French social security system or not a beneficiary of such a system.
* Participants deprived of liberty, protected adults, vulnerable individuals, or minors.
* Participants with a proven or suspected chronic infectious disease that may introduce a risk of contamination during sample handling (laboratories not equipped to handle this type of sample).
* Refusal to sign the non-opposition form to participate in the research.

Non-inclusion specific criteria

* Subject who has had a recent stroke or epilepsy event (within the past two months).
* Subject suffering from neurological diseases.
Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)

Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
* CD20-positive lymphoma
* Progressive, measurable disease
* Sign informed consent
* 3 weeks beyond standard therapy
* Good performance status
* Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

* Chronic lymphocytic leukemia
* Lesions greater than or equal to 10 cm in diameter
* CNS lymphoma
* AIDS-related lymphoma
* Pleural effusions or ascites secondary to lymphoma
* Active, opportunistic infection
* Serious nonmalignant disease
* Prior investigational therapies, including prior anti-CD20 therapy
* Recent major surgery
Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.

The objective of this randomized prospective multicenter study is to investigate the association between the time of removal of drain after pancreaticoduodenectomy (PD) and incidence of major complications (grade 2-4 complications). The investigators unite six pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative pancreatic fistula (POPF) are recruited into the study. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 5 or beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive complication index (CCI).

Eligibility Criteria:
Inclusion Criteria:

1. PD with or without pylorus preserving;
2. Age between 18 and 75 years;
3. Drain amylase on POD 1 and 3 less than 5000 U/L;
4. Drain output within POD 3 less than 300 ml per day.

Exclusion Criteria:

1. Vascular reconstruction using an artificial graft;
2. Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery;
3. Refusale to participate in after signed informed consent.
Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction Syndrome (SMDS)

The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients.


Eligibility Criteria:
Inclusion Criteria:

* bodyweight ≥ 12 kg
* native (not surgically replaced) ascending aorta
* diagnosed with SMDS with confirmed ACTA2 mutation disrupting arginine 179
* females with negative urine pregnancy test
* must agree to use acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study

Exclusion Criteria:

* Individuals who have undergone surgery to replace aneurysmal or dissected ascending and root aortic tissue with a graft.
* Additional medical conditions that impair the patient's ability to participate in the study.
* Known allergy or sensitivity to niacin or nicotinamide riboside.
* Prior consumption of niacin or nicotinamide riboside supplement within the prior eight weeks.
* Failure to provide informed consent.
* Inability to tolerate PET/CT imaging and echocardiography without sedation.
* Concurrent participation in another intervention trial.
"HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions

This study is intended to provide a basis for decision-making for the improved medical care of patients with asymptomatic heart failure, especially in structurally weak regions.

The aim of the study is the early detection of asymptomatic heart failure with a quality-assured cardiac screening MRI in the population in structurally weak regions and especially in patients with risk factors for the occurrence of heart failure. The diagnosis is followed by early initiation of appropriate therapeutic measures to improve the prognosis of the affected patients, avoid hospitalisations and save therapy costs, and is combined with recommended measures to minimise risk factors for the development of heart failure. The project includes a prospective, monocentric, randomised controlled clinical trial with blinded assessment of the endpoint (PROBE design). Within the scope of the study, 4,509 patients aged between 40 and 69 years who have characteristic risk factors for the development of heart failure were examined using a mobile cardiac screening MRI in the federal states of Brandenburg and Mecklenburg-Western Pomerania within Germany.

Eligibility Criteria:
Inclusion Criteria:

* Smoking
* Hypercholesterolaemia
* Arterial hypertension
* Obesity
* Chronic diabetes mellitus
* Chronic kidney disease
* Health insurance

Exclusion Criteria:

* Previously diagnosed Heart Failure
* MRI-exclusion criteria
Urine CXCL10 Chemokine Monitoring Post-renal Transplant

In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.


Eligibility Criteria:
Inclusion Criteria:

* All consenting adult (age\>=18) renal allograft recipients

Exclusion Criteria:

* Human Leucocyte Antigen (HLA) -identical living donor transplantation
* Primary non-function
* Participation in immunosuppression interventional trials
A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever

Amphotericin B is a polyene antifungal drug used for the treatment of many systemic fungal infections. It is associated with many side effects which in some cases can be very severe and potentially lethal. Lipo-AB® is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Prior studies showed that the liposomal formulation of amphotericin B greatly reduces the side effects of the parent drug, such as nephrotoxicity. This study is designed to evaluate the safety and efficacy of Lipo-AB® in neutropenic patients with persistent fever in routine clinical practice in Taiwan.

1. Primary objective:

   • To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic patients with persistent fever in Taiwan clinical practice.
2. Secondary objectives:

(1) To evaluate the safety profile of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice.

(2) To evaluate the treatment efficacy of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male with no age limit
2. Patient for whom Lipo-AB® is medically recommended due to following conditions:

   * Absolute neutrophil count (ANC) \< 500/mm3 for at least 96 hours
   * Received parenteral broad spectrum antibacterial therapy for at least 96 hours
   * Fever of ≥ 38.0°C (tympanic temperature)
3. Subject or his/her legally acceptable representative is willing and able to provide a written informed consent

Exclusion Criteria:

1. Pregnant female, with the exception of those for whom the possible benefits to be derived outweigh the potential risks involved
2. Use of other investigational product 2 weeks before the initiation of Lipo-AB® treatment which is considered not suitable for this study by investigator
3. Use of any parenteral antifungals for current infection which is not considered treatment failure (either intolerance to the drug or lack of response)
4. Any condition which is considered not suitable for liposomal amphotericin B therapy by investigator