cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster

The purpose of this study is to evaluate the efficacy and safety of Foscarnet Sodium and Sodium Chloride Injection in patients with herpes zoster, and observe incidence of Postherpetic neuralgia


Eligibility Criteria:
Inclusion Criteria:

1.Patients with clinical diagnosis of Herpes Zoster, and able to be enrolled into the study ≤ 72 hours from appearance of rash; 2.18-65 years old, men and women; 3.VAS score≥4; 4.Patients haven't receive any antiviral medication before enrollment; 5.Patients able to understand the study procedures, agree to participate and give written consent.

Exclusion Criteria:

1. Patients with history of allergy to Foscarnet Sodium or Acyclovir;
2. Other combined infection (bacteria, fungi)
3. Severe decline in immune function, or long-term use of corticosteroid and immunosuppressor
4. Serious liver or renal function abnormalities (Aspartate Transaminase(AST) or alanine transaminase(ALT) ≥ 2.5x upper limits of normal(ULN), Creatinine(Cr) or Blood urea nitrogen(BUN)≥ 1x ULN)
5. Women who are pregnant or lactating, and women of childbearing potential failed to use an adequate method of contraception to avoid pregnancy;
6. Patients using other antiviral drugs;
7. Long-term use of non-steroid anti-inflammatory drug, tricyclic antidepressant, anti-epileptic drugs or analgesic
8. Current malignant tumor;
9. Patients investigators consider as inappropriate to participate in the study
The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis

This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis.

Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis.

Design: a prospective, single-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with hyaluronic acid under ultrasonographic guidance plus PT) and group 2 (PT alone). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, Shoulder Pain And Disability Index, and the Short Form-36

Eligibility Criteria:
Inclusion Criteria:

1. a duration of complaints more than 3 months
2. a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.

Exclusion Criteria:

1. prior manipulation of the affected shoulder under anesthesia;
2. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
3. neurologic deficits affecting shoulder function in normal daily activities;
4. shoulder pain caused by cervical radiculopathy
5. a history of drug allergy to hyaluronic acid;
6. pregnancy or lactation;
7. received injection into the affected shoulder during the preceding 3 months
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia

The purpose of the study is to evaluate efficacy and safety of argatroban in the patients with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The reason of the lower initial dose is that the approved dose of argatroban in Japan (for the treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the relationship among the dose, aPTT, and blood drug concentration.


Eligibility Criteria:
Inclusion Criteria:

1. Males of non-pregnant females \>=20 and \<=80 years of age
2. Those with the diagnosis of HIT or HITTS made by the following diagnostic criteria, or those who have positive results of HIT antibody

   * diagnostic criteria of HIT
   * a fall in platelet count to less than 100,000/μL or a 50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT
   * diagnostic criteria of HITTS

     * those who met the diagnosis criteria of HIT
     * presence of an arterial or venous thrombosis documented by appropriate imaging technique (ultrasound, angiography etc.) or supported by clinical evidence such as a myocardial infarction, stroke, pulmonary embolism, or other clinical indications of vascular occlusion(absence of pulse, cold, cyanotic extremities, etc.)
   * patients with history of HIT/HITTS with positive test results (HIT antibody or platelet function test) could be enrolled without present thrombocytopenia
3. patients willing and able to give informed consent

Exclusion Criteria:

1. any condition which in the investigator's opinion, contraindicated the use of argatroban or endangered the patient if he or she participated in this trial
2. clinically significant or uncontrolled endocrine, renal, pulmonary, gastrointestinal, or psychiatric disorder of sufficient severity that the investigator deemed antithrombotic therapy with argatroban to be contraindicated
3. unexplained aPTT\>200% of control at baseline
4. documented coagulation disorder or unexplained bleeding diathesis unrelated to HIT
5. lumbar puncture within the past 7 days
6. known clinical site of bleeding. Patients with a known site of clinical bleeding could be enrolled if the investigator deemed the risk of continued thrombosis outweighed the potential bleeding risk
7. serious liver disfunction
8. females of known or suspected pregnancy
9. breast feeding females
10. participation in other clinical drug trials within the past 30 days
11. history of hypersensitivity to argatroban
12. concomitant use of cimetidine
13. previous participation in this trial
Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression

The investigators plan to conduct a randomized controlled trial to examine whether a Smartphone-based Intervention improves subthreshold depression symptoms compared to no intervention.

The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Males and females
* Center for Epidemiologic Studies Depression Scale score ≥16
* Written informed consent prior to participation
* Owns a smartphone with the iOS® operating system

Exclusion Criteria:

* Lifetime history of psychiatric disorders
* Currently receiving treatment for a mental health problem from a mental health professional
* Experience of a major depressive episode in the 2 weeks prior to the study, as ascertained using the Mini-International Neuropsychiatric Interview
* Vision or hearing deficits that negatively impact everyday life
Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

To study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.

The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients. It had been showed that DA inhibit prolactin secretion by binding to and activating dopamine D2 receptors.PET-MR combined MR images with PET function images is substantial to evaluate the expression of dopamine D2 receptors.The aim is to study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of DA.

Eligibility Criteria:
Inclusion Criteria:

1. Hyperprolactinemia;
2. Enhanced pituitary MRI shows sella regional tumor;
3. Aged between 18 and 65 years old, either sex;
4. Karnofsky performance status ≥ 70;
5. The patient has signed the informed consent.

Exclusion Criteria:

1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
2. Patients with parkinson disease and is taking dopaminergic agents;
3. Patients with prolactinoma who received Gamma knife treatment;
4. Pregnant or lactating women, or women preparing pregnant;
5. Patients with poor compliance, who cannot implement the program strictly.
6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabergoline.
7. Patients with claustrophobia
Digestive Properties of Carbohydrate-based Foods

Gastric emptying rate, glycemic response, fermentation, and appetitive response are being assessed after consumption of traditional West African carbohydrate-based foods (pearl millet couscous, pearl millet thick porridge) and Western type carbohydrate-based foods (wheat couscous, white rice).

Anecdotal evidence suggests that couscous made from pearl millet (Pennisetum glaucum), hereby referred to as millet couscous, is highly satiating in populations living in the West African Sahel. Results from a previous human study conducted the investigators indicated that traditional West African foods made from pearl millet and sorghum (millet couscous, millet thick porridge, and sorghum thick porridge) exhibit markedly delayed rates of gastric emptying compared to Western foods (pasta, boiled potatoes, and white rice) in a population from Mali, Africa. The delayed gastric emptying rate of the thick porridges can be attributed at least partially to the impact of viscosity, while the cause of the delayed gastric emptying rate of the millet couscous remains unclear. The overall aim of this research is to determine why millet couscous exhibits a delayed rate of gastric emptying, while also assessing other digestive properties to gain a better understanding of the factors that could be contributing to this outcome. Therefore, gastric emptying rate, glycemic response, fermentation, and appetitive response are all being assessed for West African and Western foods in a population residing in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index (18.5 \< BMI \< 25 kg/m2)
* Normal fasting blood glucose

Exclusion Criteria:

* Diabetes
* Allergy to millet
* Allergy or sensitivity/intolerance to gluten
* History of gastrointestinal disease
* Pregnant or nursing
Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Sensor Augmented Insulin Pump in Children

The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed system significantly reduces hypoglycemic excursions and thus provide proactive protection to the user.

This is randomized two-arm parallel controlled open label study that will be conducted at two sites, in Slovenia and Israel. It is an investigator initiated pediatric clinical study.

Study will be conducted on pediatric population during two weeks, following a 3 day Run-in period that will allow the patients to get familiar with study device and CGM (SmartGuard OFF).

Patients will be asked to continuously wear the study device for 14 days, which will be set up by study staff according to randomization in the specific group. They will be provided with a diary for entering their daily activity, food consumption (carb count) and eventual adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry
* Diagnosed with Type 1 DM at least 12 months prior to signature of Patient Informed Consent (PIC).
* Age between 8-18 years old (inclusive) at signature of PIC
* Treated by CSII with or without CGM at least 3 months prior to signature of PIC, but no use of LGS for last two weeks prior to signature of PIC.
* HbA1c value at screening visit ≤10%
* Knowledgeable on the use of CSII, administering treatment, adjusting insulin according to diet and exercise
* Performance of an average of four (4) SMBG per day, as evidenced from patient files, or latest insulin pump or glucose meter download
* Treated by the investigator's centre for at least 6 months prior signature of PIC.
* Willing to undergo all study procedures

Exclusion Criteria:

* Hearing or vision impairment so that glucose display and alarms cannot be recognized.
* Alcohol or drug abuse.
* Non-compliance with diabetes self-monitoring and disease management
* Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
* Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g. chronic corticosteroid therapy),
* Eating disorders and morbid obesity (defined as adults: BMI\>35 and children BMI \> 2 SD for age) as assessed by the investigator.
* Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
* Patient that does not have a reliable support person.
* Participation in another clinical study, on-going or completed less than 2 months prior to signature of PIC.
* Pregnancy (per investigator judgment, including pregnancy test if necessary)
Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization

A double-blind within person randomized controlled trial study was conducted on 90 wounds in 22 subjects. All wounds were randomized to receive either sodium fusidate ointment or petrolatum following cauterization.

All eligible participants were randomized to be applied sodium fusidate ointment (intervention) or white petrolatum (control) on the lesions on their face with 1:1 ratio. Allocation sequence was generated by a statistician with a computer and it was concealed from the researchers and participants. The ointment was prepared and packaged by a pharmacist. Each pot was numbered in accordance with the allocation sequence.

Electrosurgery was carried out using Ellman® Surgitron. Prior to the cauterization, we performed infiltration anesthesia around the lesion with Pehacain® (containing 20 mg of lidocaine and 0.0125 mg/ml epinephrine). The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment or petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. This sheet contained information on how to wash the face or body properly, how to apply the ointment properly, what to avoid after procedure (rubbing the wound excessively, use make up, sweating excessively, and use other topical agents on the wound), and follow-up instructions (on the 3rd, 7th, and 14th day). Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

Wound monitoring, which includes erythema, edema, crusting, re-epithelialization, total wound healing score, pus, and subjective symptoms was performed on the 3rd, 7th, and 14th day. Erythema scores was also monitored immediately after electrosurgery. Monitoring can be done 1 day earlier or later than schedule in some cases since the wound healing phase is expected still the same. Clinical grading of each site was carried out using a 5-point analog scale for erythema, edema, crusting, re-epithelialization, and total wound healing score.

Eligibility Criteria:
Inclusion Criteria:

* age over 20 years
* clinically diagnosed with seborrheic keratosis or acrochordon
* having minimum of two lesions and maximum of four lesions with diameter of 4-10 mm on face or neck and minimum distance between lesions of 5 cm
* providing consent to participate into the study

Exclusion Criteria:

* a skin bacterial infection on the other parts of body's skin
* benign tumor lesions with inflammation or secondary infection
* history of antibiotics use in the last 2 weeks or long-acting penicillin injections within the past 1 month
* history of corticosteroids and immunosuppressants use in the past 2 weeks
* using a pacemaker
* infected with Coronavirus disease 2019 (Covid-19).
Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial

The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-30 years old or 31-46 years old
* Have reoccurring panic attacks

Exclusion Criteria:

* Suicide prone
* Alcohol addiction
* PTSD
* OCD
* Ongoing psychological treatment
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study

This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non- pregnant female ≥ 18 years of age
2. Life expectancy ≥ 1 year
3. Ejection Fraction (EF) \>15% and ≤ 40%
4. Scheduled for an elective high risk percutaneous coronary intervention

Exclusion Criteria:

1. Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from a previous value OR ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure
2. Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation
3. Cardiogenic shock
4. Left ventricular (LV) mural thrombus
5. Presence of a prosthetic valve or a heart constrictive device
6. Aortic stenosis
7. Moderate or severe aortic regurgitation (≥ 2+ by echo)
8. Severe peripheral vascular disease that will preclude the use of a 12F access sheath, which is required for the insertion of the CSI pVAD catheter
9. Severe aortic tortuosity
10. Severe aortic calcification
11. Vasculature will not tolerate a right heart catheterization
12. Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis
13. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate dehydrogenase (LDH) \> 2.5X ULN
14. Uncorrectable abnormal coagulation parameters
15. History of heparin induced thrombocytopenia
16. Sustained ventricular tachycardia
17. Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit
18. Chronic anemia (hemoglobin \< 8 g/dL)
19. Subject may require long term support with a commercially available hemodynamic support device
20. Active systemic infection requiring oral or intravenous antibiotics
21. Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
22. Allergy or intolerance to system components
23. Participation in another investigational drug or device study
Postprandial Differences After Herring and Beef

While observational studies often find that diets rich in fish reduce the risk of disease, and that diets including a high intake of red meat are associated with increased risk of cardiovascular disease and cancer, the difference in health effects between red meat and fish are rarely researched in intervention studies.

The investigators hypothesise that the post-prandial plasma response of lipids and markers of cardiovascular disease risk will be more favourable after intake of herring compared to beef.

In addition, while pickling herring in a brine/sugar solution is a common form of preparation, little is known if there is a difference in potential health effects based on the preparation of herring. The investigators will compare baked and pickled herring to understand if preparation is potentially an important factor to be considered when looking at intake of fish and health.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 35-67 years
* BMI \>30 kg/m2
* Normally eats lunch and dinner

Exclusion Criteria:

* Smoke or oral tobacco use
* Use of prescription or recreational drugs likely to interfere with primary outcome
* Change in body weight in the month prior to the study
* Abnormal blood biomarker values (assessed by a clinician)
Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain

This study evaluates whether different explanations given to patients with long lasting back pain influence a physical therapy treatment technique. Half of the patients will receive an explanation of the proposed treatment technique focusing on how their joints are moving and not moving. The second half of the group will receive the same treatment technique as the first group, but their explanation of the technique's purpose will focus on how their brain interprets the information. The study aims to determine if patients have a different response to the treatment based on the words chosen to explain the technique.

Traditional treatment provided by physical therapists to patients with chronic low back pain focuses on the biomechanical or anatomical impact to local tissues. Recent research has shown that treatment effects may be more related to the understanding of the structural and functional changes in the brain of someone suffering from chronic low back pain. This research implicates that the patients understanding and interpretation of input to the brain may change the patient's perceived representation and interpretation of output of pain within the brain.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18
* Presenting at Physical Therapy with a primary complaint of Low Back Pain
* Low Back Pain being present for 6 months or more
* Fluent in English and willing to participate in the study.

Exclusion Criteria:

* Medical precautions to the use of manual therapy (metal, skin lesions, etc.)
* Prior spine surgery
* Unable to lay prone for the treatment.
Neuromodulation vs. Electrolysis in Plantar Fasciitis

The aim of the present study will be the implementation of two protocols in plantar fasciitis individuals: a) percutaneous neuromodulation, b) percutaneous electrolysis in plantar fascia. Authors hypothesized that percutaneous neuromodulation may have benefits in: pain, quality of life, muscular structure.


Eligibility Criteria:
Inclusion Criteria:

* Patiens with plantar fasciitis

Exclusion Criteria:

* Lower limb disturbances
* Sistemic diseases
* Not involved in other drug or manual therapy interventions
* Infections