cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cilostazol on Rheumatoid Arthritis Patients

The goal of this study is to evaluate the effect of cilostazol on Rheumatoid Arthritis patients. It aims to answer the questions of :

1. Will Cilostazol improve the disease severity and quality of life in Rheumatoid arthritis patients?
2. Will Cilostazol decrease the oxidative stress, inflammation and endothelial dysfunction in Rheumatoid arthritis patients?

Participants will be randomized into two arms either treatment or control the treatment group will be asked to take Cilostazol 100 mg twice daily in addition to the usual DMARD (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide), while the control group will be taking the usual DMARDs only.

Patients in both arms will be followed-up every 2 weeks through out the 6-month duration of the study.

Rheumatoid Arthritis (RA) is an autoimmune disease affecting joints. It usually affects females more. The available treatment aims to slow down disease progression and control the disease symptoms. Treatment is classified into either the conventional DMARDs (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide) or Biological DMARDs such as an Anti-TNF alpha ( Certolizumab, Infliximab , Etanercept or Golimumab) or non-TNF biologics (Rituximab, Abatacept or Tocilizumab). Both classes have their drawbacks. The conventional DMARDs is not effective for many patients and the biological DMARDs have a high cost making their use limited to patients with medical insurance or patients who can afford it, thus making it necessary to find new medications which can improve the outcomes in patients with RA.

Cilostazol is an antiplatelet agent used mainly for intermittent Claudication. Recently many preclinical trials have shown efficacy of cilostazol in RA via it's anti-inflammatory action. it also decreases the oxidative stress which is high in ٌRA patients.

Patients will be randomized into two arms , one which is treatment and the other is control the treatment group will be asked to take Cilostazol 100 mg twice daily in addition to the usual DMARD (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide), while the control group will be taking the usual DMARDs only.

Patients in both arms will be followed-up every 2 weeks through out the 6-month duration of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients. (\>18 years old).
2. Moderate to high disease activity (DAS28-CRP\>3.2).
3. Patients receiving stable cDMARD regimen for at least 3 months before inclusion in the study.

Exclusion Criteria:

1. Hypersensitivity to cilostazol.
2. Heart failure.
3. Pregnant and lactating women.
4. Patients with liver impairment (ALT or AST \> 3\* ULN).
5. Patients with renal impairment (CrCl\<60 mL/min).
6. Patients receiving any other antiplatelet or anticoagulant
Gastric Preparation of Magnetic-controlled Capsule Endoscopy

By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the investigators hope to find out the optimal gastric preparation plan.

It is a prospective, single-blind, randomized controlled trial. Patients who were conducted by Magnetic-controlled Capsule Endoscopy at Changhai Hospital will be randomly allocated into three different Gastric Preparation group before the procedure. It include clear water group which patient only drink 1000ml clear water before checking; simethicone group which patient drink 950ml clear water and 15ml simethicone before checking; simethicone combined with pronase group which patient drink 900ml lear water and 15ml simethicone and 20，000iu pronase before checking. The result were got from a relevant professional physician's blinded independent image-reading.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 16-75 years, who were scheduled to undergo a Magnetic-controlled Capsule Endoscopy, were eligible for this study.

Exclusion Criteria:

* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
* Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
* Pregnancy or suspected pregnancy;
* Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
* Currently participating in another clinical study.
Controlled Trial of Valacyclovir in Infectious Mononucleosis

The hypothesis is that an antiviral drug (valacyclovir) will reduce the amount of Epstein-Barr virus (EBV) in the mouths of university students with infectious mononucleosis (mono) while being a safe drug. Because EBV is the cause of mono, it is expected that reduction of the amount of virus could result in faster recovery from the disease.

University of Minnesota students 18 years of age or older who are referred by the Boynton student health service during the first 7 days of infectious mononucleosis are eligible to participate. All of the subjects who enroll will be allowed to complete the study, but only the information from those students who truly have mono due to a primary infection with EBV as determined by laboratory tests will be used for the results. The students will be assigned by chance(randomized)either to receive the antiviral drug valacyclovir at a dosage of a 1 gram tablet every 8 hours for 14 days or no antiviral drug. Nine research clinic visits over 180 days are scheduled for clinical exams, histories, and collection of mouth and blood samples. The amount of EBV in the mouth and blood will be measured by a molecular virology research test called real-time TaqMan polymerase chain reaction. The severity of illness will be evaluated using a scale that measures the degree of physical activity and intensity of symptoms. The safety of the drug will be monitored by periodically checking the blood cell counts, and assessing liver and kidney function among other parameters. Personnel who do the lab work and analyze the data will not know the subjects' study drug assignments so that the data can be collected and analyzed objectively. The study will remain open to enrollment until 20 subjects with laboratory-confirmed primary EBV have been enrolled and followed for at least 2 weeks. The study will end when all subjects complete all scheduled study visits.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of infectious mononucleosis with onset no more the 7 days before enrollment; willingness to sign informed consent
* Willingness to provide blood and oral washing samples at regular intervals
* Females must have a negative urine pregnancy test and agree to use effective contraception (barrier or hormonal) for the first 30 days of the study if assigned to valacyclovir
* Corticosteroids are permitted only if prescribed by the subject's primary physisican for treatment of this acute disease

Exclusion Criteria:

* Previous history of mono
* Pregnant or breast feeding
* End-stage renal or liver disease
* Immunosuppressed due to underlying medical disease and/or immunomodulating medications prior to enrollment
* Onset of present illness \>7 days ago
The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars

The purpose of this study was to assess the efficacy of local anesthetic and tramadol combinations in the prevention of pain after the surgical extraction of third molars.

The surgical removal of impacted third molar teeth is a procedure that is frequently encountered in oral and maxillofacial surgery practices. Pain following these operations is one of the most important factors affecting patient satisfaction. Several pain-management strategies are available. An alternative approach to pain control is to maximize drug levels at the tissue injury site by administering drugs locally.

Tramadol is a centrally acting opioid that provides good analgesia. It reduces the transmission of pain impulses by inhibiting serotonin and norepinephrine re-uptake. In addition to the systemic analgesic effects, the local anesthetic effects of tramadol on the peripheral nerves have been presented in multiple clinical and laboratory studies.

The aim of this study is to test the clinical efficacy of local anesthetic and tramadol combinations during and after the surgical extraction of the lower third molars.

Eligibility Criteria:
Inclusion Criteria:

* Score of ASA I-II (American Society of Anesthesiologists Physical Status I or II)
* Patient weights were less than 60 kg

Exclusion Criteria:

* Subjects who had taken a sedative, tranquillizer, or analgesic medication within the last 24 h,
* Sensitive to tramadol,
* Patients who needed an extra dose of anesthetic solution during the surgery
Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim of this study was to evaluate the efficacy of atropine sulfate for prevention of brad arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.

120 candidates, ASA 1 in the age range 18-40 years scheduled for elective diagnostic gynecological laparoscopic surgery were randomly assigned into 4 groups to receive either atropine sulfate or normal saline solution (as placebo).

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18-50 years scheduled for elective diagnostic gynecological laparoscopic surgery

Exclusion Criteria:

* Cardiac
* Diabetes Mellitus
* Thyroid disease
* Any endocrine disease
Probiotics in Prevention of Allergies, Obesity and Caries

During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age. The effects of LF19 on gut microbial composition, infections, allergies, immunological development, growth and blood lipids were monitored. Of 179 included infants, 171 completed the study. The study product was well tolerated with no observed side effects. Compliance was excellent.

In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during weaning on allergies, immune programming, overweight, gut microbial composition and oral health in 8-year old children.

The investigators' primary outcome will be to determine whether daily intake of LF19 during weaning results in less eczema at 8 years of age, and if the preventive effect encompasses also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects on gut microbial composition, overweight and metabolic markers will be investigated. Furthermore, the possible preventive effects of LF19 on caries will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants born at term (gestational age 37-42 weeks)
* Birth weight \> 2500 g
* Vaginally delivered
* No atopic manifestation
* A normal diet for age
* No medication that could have affected the intestinal microbiota
First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors

Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024.

This is a first-in-human, open-label, sequential dose escalation study to evaluate AB0024 in patients with advanced solid tumors. The study will consist of two parts: Part A will be a dose escalation, and Part B will be a dose expansion.The primary objective of this study is to characterize the safety, tolerability, and PK of AB0024 after multiple IV administrations in patients with advanced solid tumors. The secondary objectives are to measure the tumor response by modified RECIST and to evaluate the formation of anti-AB0024 antibodies.

Patients will receive infusions of AB0024 every two weeks. Patients will be seen weekly for safety assessments and collection of blood samples. Patients who do not show evidence of disease progression by clinical assessment or by CT or MRI may continue receiving AB0024 every 2 weeks until disease progression (clinical or radiographic), study drug intolerance, or withdrawal of consent.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available
* Measurable or evaluable disease
* ECOG Performance Status of ≤2
* No known active central nervous system (CNS) tumors or CNS metastases
* Adequate organ function

Exclusion Criteria:

* Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association Classification \> Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
* History of surgery within 28 days prior to enrollment or anticipated surgery during the study period
* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 28 days of study Day 1 (six weeks for nitrosoureas, mitomycin C, antibodies, or molecular agents with t½ \>10 days); (concurrent use of hormone therapy for breast or prostate cancer is permitted)
* Treatment with immune modulators including, but not limited to, cyclosporine and tacrolimus within two weeks prior to enrollment
* Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy; (low-dose warfarin \[\<2 mg/day\] for prophylaxis against central venous catheter thrombosis is allowed)
* Patient with tumor that is infiltrating or invading a major blood vessel
Loss of Effect of Aspirin on Platelet Aggregation During Chronic Administration

Aspirin has shown to be beneficial to some patients with certain diseases such as coronary artery disease or stroke. We are investigating how aspirin works on regulating platelets and thromboxane over time at different doses. We hope to find the best dose of aspirin and/or other medications to help people who are at risk for heart attack or stroke.

he purpose of the study is to better understand the mechanism for failure of daily aspirin administration to prevent cardiovascular events in some at risk individuals. We seek to describe the effect of chronic aspirin administration at varying doses on platelet aggregation. This will help to define mechanisms for aspirin failure and to pursue possible alternative therapies in patients who fail to respond to aspirin therapy.

We hypothesize that (1) inhibition by aspirin (ASA) of ex vivo-induced platelet aggregation varies in a predictable time and dose dependent manner, (2) thromboxane and prostacyclin production is inhibited by ASA in a dose-dependent manner and remains relatively constant over time once maximal inhibition has occurred, and (3) granule secretion by platelets during induced aggregation is inhibited by aspirin acutely but this effect does not persist during chronic administration at high doses.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age 18-40 years
* Non-smokers

Exclusion Criteria:

* ASA/NSAID use previous 14 days.
* Evidence of ASA/NSAID use within previous 14 days at baseline visit based on investigator interpretation of platelet aggregation and platelet secretion studies.
* History of chronic NSAID use.
* Currently taking NSAIDs, corticosteroids, or anticoagulants.
* History of coronary artery disease, myocardial infarction, coronary artery bypass grafting, percutaneous angioplasty, diabetes mellitus or stroke.
* History of gastric,duodenal, or esophageal ulcers or serious gastrointestinal bleed.
* History of frequent headaches, pain syndrome, or other condition requiring frequent use of analgesics.
* History of adverse reaction to ASA.
* Initial platelet count \<100K/µl or \>500K/µl.
* Initial hematocrit \<35% or \>50%.
* Weight less than 110 pounds.
Renal Sympathetic Modification in Patients With Heart Failure

The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.

Heart failure is a clinical syndrome of chronic cardiac dysfunction, with high morbidity and mortality. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that partly blocking sympathetic nerves activity contributed to improve cardiac function in patients with heart failure. Renal ablation with sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. The investigators hypothesis that renal sympathetic nerves modification is effective and safe in improving cardiac function. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary anti-heart failure drugs besides expectant intervention, and patients in control group will receive appropriate anti-heart failure drugs only. The investigators aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old, and ≤ 75 years old of age
* more than half a year history of heart failure, except for valvular heart disease
* heart failure patients NYHA Class II III IV
* left ventricular ejection function ≤ 40% or ≥ 45% (that is heart failure with preserved ejection fraction) with Simpson's method
* estimated glomerular filtration rate (eGFR) of ≥ 45mL/min
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* patients with acute heart failure
* patients with acute coronary syndrome
* estimated glomerular filtration rate (eGFR) of \< 45mL/min
* has the history of renal restenosis or renal stents implantation
* has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
* patients with sick sinus syndrome
* pregnant women
* mental disorders
* patients that have allergy to contrast agent
* patients that do not go with follow-up
* others such as researcher considers it is not appropriate to be included into the study
Effects of Telerehabilitation Based Motor and Cognitive Dual Task Exercises in Patients With Parkinson's Disease

The ability to respond to multiple stimuli is impaired in Parkinson's patients. Traditional rehabilitation approaches focus only on balance and gait training, but individuals with Parkinson's disease need to perform multiple tasks in daily life.

The dual-task (DT) methodology aims to perform two tasks simultaneously. There is no study in which motor and cognitive dual-task exercises are given together and followed up remotely in elderly individuals with PD.

Therefore, it was aimed to compare the effects of telerehabilitation method and motor and cognitive dual-task exercises on cognitive function, balance, walking, fall risk and quality of life in individuals with Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with idiopathic Parkinson's Disease

  * Getting at least 21 points from the Montreal Cognitive Assessment Scale test
  * Stability of drug therapy taken in the last 1 month
  * Being in the "ten" period of the patients
  * Being able to walk independently on flat ground (3 and above according to Functional Ambulation Classification)

Exclusion Criteria:

* • Serious hearing or vision problems

  * Having other neurological, cardiovascular or orthopedic disorders that may prevent walking
  * Any other neurological disorder (eg dementia, cerebrovascular disease)
  * Having an education level of less than 5 years
  * Patients with a pacemaker
  * Having vascular lower extremity pathologies
  * Not having internet access with a smart phone or computer
Probiotic Intervention After Surgical Removal of Mandibular Third Molars

Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. Patients were assessed for surgery-derived complications in a follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and eating difficulty in a patient diary.

This was a single-centre, prospective, double-blind, randomized, placebo-controlled, parallel-group study to evaluate whether probiotic supplementation during 1 week after surgery reduced post-surgery complications compared to placebo.

Healthy subjects of both genders aged between 14 and 25 years who required the surgical removal of both mandibular 3rd molars were recruited from the department of Oral and Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital of Barcelona).

Patients were randomly assigned to receive probiotic tablets containing a mixture of L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice a day for 7 days post surgery.

Patients were assessed by trained specialists for surgery-derived complications (fever, oral alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients also provided daily evaluations for pain, swelling and eating difficulties in a patient diary.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy male and female undergoing surgical removal of both third mandibular molars.
* Aged between 14 and 25 years.
* Providing informed consent if 18yr and older, or parents/guardians providing informed consent otherwise

Exclusion Criteria:

* Subjects with gingival index (GI; according to Loe and Silness. 1963) or dental plaque index (PlI; according to Silness and Loe. 1964) above 2 in the CPI Community Periodontal Index) teeth subset.
* Subjects having used probiotics or antibiotics within 30 days prior to study enrollment.
* Tobacco use
* Pregnant and breastfeeding women.
* Known allergies to ingredients in study products.
* Not willing to refrain from using mouthwashes during the study period