cyrilzakka/clinical-trials huggingface dataset:
A Study of Hemay005 in Adult With Atopic Dermatitis

A multicenter, randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of Hemay005 tablet in the treatment of moderate to severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign the informed consent form for this study;
* 18-75 years old (including boundary value) , gender is not limited;
* Ability to adhere to follow-up schedules and other program requirements;
* According to Hanifin \& Rajka diagnostic criteria of atopic dermatitis (AD) , the patients with AD history ≥6 months;
* At baseline, the severity of AD was moderate to severe: IGA score was 3 or more, and the area of involved skin lesion was 10% BSA or more;
* Participants were required to use contraception during the study period.

Exclusion Criteria:

* A medical history unsuitable for participation in a clinical study；
* Pregnant or lactating women；
* Allergic to the drug or its preparation；
* Patients who had undergone major surgery within 6 months before screening or who were scheduled for major surgery during the trial period；
* Participants who had participated in any drug or device clinical trial within the previous 3 months were screened；
* Vaccination with live or attenuated vaccines is planned for the duration of the trial；
* Any drugs is taking that may affect the effectiveness evaluation;
* Any clinically significant abnormality in 12-lead ECG at screening that was judged by the investigator as unsuitable for inclusion；
* When investgater believe that any condition could lead to unnecessary risks for patients participating in the study.
Socket Seal Surgery

laser photo biomodulation (PBM) as a supplement to socket seal surgery

the role of PBM therapy as an adjunct for bioactive glass graft in SSS approaches

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least a periodontal-affected and non-restorable tooth in posterior region (Class II sockets).
* At least 10% plaque control scoring was accepted
* A moderate to thick gingival phenotype

Exclusion Criteria:

* systemic diseases or conditions that may compromise healing or bone metabolism,
* having a history of radiotherapy, chemotherapy or bisphosphonate therapy, previous use of antibiotics in the last 3
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA

The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.

Primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (UDCA) is the only drug approved for the treatment of PBC. Although UDCA can improve the clinical outcomes in patients with PBC, about 40% of PBC patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. Therefor there is a urgently needed for better therapies for these patients. The development of new treatments is therefore needed. The Fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that Fenofibrate is well tolerated and can improve biochemical response in PBC patients with incompleted response to UDCA. The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.

Eligibility Criteria:
Inclusion Criteria:

1. PBC Patient , previous treatment with UDCA 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response;
2. Patients who showing an incomplete biochemical response to UDCA as defined by: ALP \> 3ULN,AST\> 2N ,total bilirubin \>17 µmol/l after ≥ 12 months of UDCA at the dose of 13 - 15 mg/kg/day.

3,signed informed consent after careful review of information and study details.

Exclusion Criteria:

1. Hypersensitivity to fenofibrate
2. Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
3. Decompensation PBC, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
4. Anticipated need for liver transplantation within one year
5. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
6. Acute or chronic renal failure
7. Known history of cholecystitis with intact gallbladder
8. Pregnant or nursing women
Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients

One interesting approach to the treatment of addiction is the use of Eye Movement Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the feasibility and efficacy of EMDR on addiction is limited and often lacks methodological rigor, the results are promising and suggest that further research on this subject is warranted.

This proposal consists of two studies to test and determine the acceptability, feasibility and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol dependent outpatients as well as to gain further understanding in underlying working mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of alcohol dependence or abuse (meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR criteria (American Psychiatric Association, 2000);
* Age of at least 18 years or older;
* Can speak and read Dutch language;
* Consent (written) to postponed information given.

Exclusion Criteria:

* Meeting the DSM-IV-TR (American Psychiatric Association, 2000) criteria for current (in the past 2 weeks) addiction and regular use (at least once per week in the last two weeks before baseline screening) of drugs other than alcohol or nicotine (relative exclusion: decision on case-by-case basis whether it leads to therapy-interference);
* Meeting the DSM-IV (American Psychiatric Association, 2000) criteria for current (in the last two weeks before baseline screening) regular alcohol use (at least \> 21E (women) or \> 28E (men) per week) (relative exclusion: decision on case-by-case basis) (relative exclusion: decision on case-by-case basis whether it leads to therapy-interference);
* Meeting the DSM-IV (American Psychiatric Association, 2000) criteria for current post-traumatic stress disorder (PTSD);
* Severe, current (since the start of regular treatment) psychiatric symptoms (especially manic, psychotic, suicidal and aggressive symptoms) that may endanger participants or others and jeopardize study adherence.
An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome

The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.

This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), open-label (all people involved in the study know the identity of the assigned drug), Phase IIIb study to evaluate the efficacy and safety of decitabine in the treatment of myelodysplastic syndrome (MDS). Patients are randomized (study drug assigned by chance) in 1:1 ratio to receive treatment with decitabine either 3-day or 5-day course of therapy. When a minimum of 30 patients are reached for 3-day course of therapy, the rest of the patients will all be enrolled into 5-day course of therapy. Each patient in the study treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles. The entire study duration for each patient will be approximately two years. Safety will be evaluated for each patient by monitoring of adverse events, physical examinations, vital signs measurements, electrocardiogram, hematology and clinical chemistry testing.

Eligibility Criteria:
Inclusion Criteria:

* Must have diagnosed with Myelodysplastic Syndrome (MDS) denovo (previously not present) or secondary as per the classification of French-American-British (FAB) and International Prognostic Scoring System (IPSS) greater than or eaul to 0.5 as determined by complete blood count (CBC), bone marrow assessment and bone marrow cytogenetics
* Must have an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2
* Must have adequate hepatic and renal function as measured by the aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin and serum creatinine, respectively
* Must have recovered from all toxic effects of prior therapy and not received any chemotherapy for a minimum of 4 weeks (6 weeks if the patient has been treated with a nitrosoureas) prior to the first dose of study drug - Woman must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (eg, oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization)

Exclusion Criteria:

* Must not have a diagnosis of acute myeloid leukemia (greater than 30% bone marrow blasts) - Must not have received radiotherapy within 14 days before the first dose of study drug - Must not have any other prior cancer, other than superficial bladder cancer, basal cell skin and cervical cancer - Must not have associated autoimmune hemolytic anemia or immune thrombocytopenia and inaspirable bone marrow - Must not have a mental illness or any other condition (eg, uncontrolled cardiac or pulmonary disease, diabetes), that could prevent full cooperation with the study requirements.
Intercostal Nerve Cryoablation for Postoperative Pain Management

The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the magnitude and duration of postoperative pain control both in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.


Eligibility Criteria:
Inclusion Criteria:

* Descending/thoracoabdominal incision is planned
* There is reasonable expectation that the patient will be extubated within 48 hours after surgery

Exclusion Criteria:

* The patient has a known allergy to morphine or any opioid
* The patient has a known chronic pain disorder or takes daily opioid medication \> 1 month prior to surgery
* The surgeon/anesthesiologist concludes that the period for intubation will be likely be for more than 48 hours after surgery There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion.
Frailty and Surgery

Frailty has been recently re-defined as a condition that is evident over time through an excess of vulnerability to stressors, with reduced ability to maintain or regain homeostasis after a destabilizing event, and occurrence of disability. Frailty has been often used to characterize the weakest and most vulnerable subset of older adults, because of age, comorbidities, social and emotional status leading to the lack of functional and psychological reserve and mining the capability to face acute events. Frail patients are becoming ever more present in Anesthesia and Intensive Care. In fact, 30 percent of surgery is conducted on patients ≥ 70 years old nowadays. It has been demonstrated that the impact of surgery and anesthesiologic risk are greater in older frail subjects, and that a low functional status is associated with increased mortality. Also, post-operative delirium and cognitive disfunction are more often seen in older patients. For this reason, the worsening of the global performance status, as functional status, mobility, and cognitive status may have a large impact on patient and caregivers' life. The primary objective is to evaluate the impact at three months after hospitalization following major surgery i.e., urology, general surgery, orthopedics, on the performance status as functional status, mobility, and cognitive status of patients ≥ 70 years old. Secondary objectives are to evaluate the necessity of domiciliary care assistance and re-hospitalization or rehabilitation center admissions in three months following surgery and to evaluate the impact of the type of anesthesia used in major surgery i.e., general vs regional anesthesia, on patient performance status.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 70 years old
* Listed for major surgery in general and vascular surgery, urology, orthopedics
* Patient General Practitioner listed in the Local Health Authority of Novara

Exclusion Criteria:

* Barthel index at baseline \< 16 in the activities of daily living section
* Barthel index at baseline \< 11 in the mobility section
* Mini mental state examination at baseline \< 11
Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

Patients with the lower malignant obstructive jaundice planned to do the pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without preoperative biliary drainage), both groups has the similar surgical morbidity, no statistics significance.

Patients with the lower malignant obstructive jaundice divided into two groups:early surgery, preoperative biliary drainage + surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the lower malignant obstructive jaundice
* Total bilirubin: 150-350 umol/L

Exclusion Criteria:

* age less than 18
* emergency operation
* biliary tract stent placed
* past history of operation on pancreas
* intraoperative unresectable tumor with pancreaticoduodenectomy
* unresectable tumor or potential resectable tumor with pancreaticoduodenectomy
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.

This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
* Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
* Acceptable candidate for venipuncture and intravenous (iv) infusion
* At least 1 partial seizure with motor component per 90 days
* Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type

Exclusion Criteria:

* Previous use of lacosamide
* History of primary generalized seizures
* History of status epilepticus within last 12 months
* History of cluster seizures during 8 week period prior to screening
* Non-epileptic events, including psychogenic seizures that could be confused with seizures
* Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
* Received any rescue benzodiazepines more than once during the 28 days prior to screening
* Concomitant treatment of felbamate or previous felbamate therapy within last 6 months
* Prior or concomitant vigabatrin use
Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole

The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent, or assent with parental or guardian written consent\*
2. Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
3. Living in an onchocerciasis endemic area.
4. Age ≥4 years
5. All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). \* Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to \<6 years

Exclusion Criteria:

1. Pregnant or breast-feeding.
2. Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
3. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
4. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
5. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients.
6. Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.
7. Infection with Loa loa.
8. Height \<90 cm.
Low Risk Acute Coronary Syndrome

A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. A well-designed, randomized trial is warranted to determine if stress testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the investigators hypothesize, healthcare expenditures could be reduced and patients may not be exposed to the harms associated with more invasive cardiac testing such as coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

1. TIMI score \< or = to 2(12)
2. TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels
3. Normal cardiac biomarkers (3 sets over 12-88 hours)
4. No evidence of acute ischemia on electrocardiograms
5. Normal ejection fraction (\>40%) on echocardiography
6. Age 30-75
7. Ability to complete noninvasive stress test
8. Ability to provide informed consent

Exclusion Criteria:

1. Presence of another medical condition to explain chest pain or non-cardiac chest pain (i.e. pneumonia, costochondritis)
2. Any patient who is initially classified as low risk but whom develops recurrent symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia
3. Evidence of ischemia on electrocardiogram
4. Abnormal cardiac biomarkers
5. History of medical noncompliance or social circumstances preventing compliance
6. Life span estimated at \<1 year
7. Pregnancy
8. Refusal to sign consent
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker (closed loop stimulation \[CLS\]) which can potentially identify an incipient attack and prevent syncope by pacing.

The treatment of patients with recurrent syncope of vasovagal origin, not precipitated by usual vasovagal factors, and not associated with structural heart disease, is unsolved. The limitations of the conducted 5 pacemaker studies are a significant placebo effect of pacemaker treatment, underpowering and lack of double blinding. The pacemaker intervention has been accelerated dual chamber pacing at the time of bradycardia, which may be too late. However, a pooling of all data indicate a beneficial effect of pacing.

Vasodilatation is an obligate element of all vasovagal syncopal episodes and in many also an early sign associated with the hyperkinetic empty left ventricle which triggers the reflex wave. The principle in closed loop stimulation (CLS) is a continuous surveillance of the impedance in the right ventricle which correlates highly with myocardial contractility. When contractility is increased significantly atrial pacing with prolonged AV delay is commenced. This principle has been used in chronotropic incompetent patients and in one small study of patients with vasovagal syncope with a positive outcome. The hypothesis is that the CLS will potentially identify an incipient vasovagal attack and be able to prevent the drop in cardiac output and bradycardia by early accelerated pacing.

Patients will be treated 12 months with active pacing (CLS) and then crossed over to 12 months with passive pacing (VVI, 30 bpm).

The study will be double blinded, only a technician will know the status of the pacemaker.

Eligibility Criteria:
Inclusion Criteria:

* A clinical problem with vasovagal syncope which motivates considerations concerning pacemaker treatment.
* A positive tilt-table test.
* Exclusion of other causes for syncope by a complete diagnostic work-up allowing only minor cardiac abnormalities
* Syncope for \>= 2 years.
* Number of syncopal episodes \>= 3
* At least 1 instance of syncope within the last 6 months.
* A positive tilt-table test which reproduces the clinical syncope and is associated with a clearly abnormal haemodynamic response:

  * Vasovagal Syncope International Study (VASIS) type 1 with bradycardia \< 40 bpm, or
  * VASIS type 2A, or
  * VASIS type 2B
* Stable clinical condition
* Able to accept and follow the protocol and give written consent.

Exclusion Criteria:

* Conventional indication for pacemaker (i.e. atrioventricular \[AV\] block)
* Indication for cardiac resynchronisation therapy (i.e. left bundle branch block \[LBBB\])
* Documented atrial fibrillation or flutter
* Epilepsy
* Congestive heart failure
* History of myocardial infarction (MI) or angina pectoris
* Serious chronic disease, life expectancy \< 3 years.
* Age \< 25 years
* Pregnant and lactating women
* Participating in other investigation