cyrilzakka/clinical-trials huggingface dataset:
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease

This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in a crossover design

This study will be conducted in subjects with established Parkinson's disease in 2 parts.

Part A will examine the tolerability, safety, and pharmacokinetics of daily doses of AZ-009 for 5 days followed by 3 doses on each of days 6 and 7 in dose escalation through 3 cohorts

Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in subjects with established Parkinson's disease experiencing regular OFF episodes

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and females between 30 and 85 years of age, inclusive at the time of signing the informed consent document with a clinical diagnosis of Parkinson's Disease
* Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2.
* Willing and able to be confined at the clinical research center for the study period and adhere to overall study visit schedule, procedures and other protocol requirements.
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

Exclusion Criteria:

* Any significant medical condition, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol.
* History of clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions including gastric bypass or other weight loss
Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.

Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the basal/total ratio of daily insulin dose (b/T) in diabetic outpatients type 1 (T1) and type 2 (T2) on basal-bolus regimen, by investigating whether there is a relationship with HbA1c and episodes of hypoglycemia.

The study was commissioned by the Italian Association of Clinical Endocrinologists (Associazione Medici Endocrinologi - AME) and approved by the Ethical Committee of Cuneo Hospital (BASAL Study- OSS 001/2016 - rif ENDO 30). The research was open to all specialists taking care of patients with diabetes in Italy.

The primary endpoint was glycemic control, evaluated by HbA1c levels, according to b/T.

Secondary endpoints were occurrence of major hypoglycemic episodes according to b/T; differences between patients with T1 and T2.

An ad hoc form was developed and used to record all medical findings. The form was emailed to all participating centers who then emailed or faxed it back to our data manager. Data were checked for accuracy.

The following data were required: age, gender, body weight and height, country of origin, type of diabetes and its duration, units of basal and total (basal plus prandial) daily insulin, type of basal insulin (Glargine, Detemir or Degludec), use and dosage of metformin, and number of major hypoglycemic episodes (\<40 mg/dL or requiring caregivers intervention) in the last three months. Serum creatinine and HbA1c levels obtained within the previous two months were also required.

Each participating center recruited between 20 and 40 diabetic outpatients. Inclusion criteria were as follows: adult outpatients (≥20 and ≤80 years) with T1 or T2 diabetes mellitus, on basal-bolus insulin regimen (basal insulin, i.e. Glargine, Detemir or Degludec, plus at least two prandial insulin shots) for at least six months, usually assuming three daily meals, and capable of informed consent.

Eligibility Criteria:
Inclusion Criteria:

* adult outpatients (≥20 and ≤80 years);
* T1 or T2 diabetes mellitus;
* basal-bolus insulin regimen (basal insulin, i.e. Glargine, Detemir or Degludec, plus at least two prandial insulin shots) for at least six months;
* assuming three daily meals;
* capable of informed consent.

Exclusion Criteria:

* pregnancy;
* breast-feeding;
* severe liver or renal failure (eGFR \<30 mL/min/1.73 m2);
* use of OADs (except for metformin);
* hospitalization for any cause in the last six month;
* glucocorticoid treatment in the last six month;
* oncologic treatment in the last six month;
* Ramadan in the last six months.
Assessment and Validation of Electronic Gas and Bloating Diary

The investigator's goal is to improve the patient's compliance and accurate capture of patient reported gas and bloating symptoms, by utilizing a phone application that interactively records each gas and bloating event in addition to bowel events and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. The investigator will compare and validate the electronic gas and bloating diary with the paper gas and bloating diary.

Gas-related symptoms (GRS) such as abdominal bloating, flatulence, and belching are some of the most common gastrointestinal complaints posed by the general population. These are hallmark symptoms in patients with functional gut disorders like irritable bowel syndrome but have also been linked to conditions such as gut hypersensitivity, altered gut microbiota and altered gut motility. The main issue with grasping the full impact of these symptoms on a patients' quality of life is that they are largely subjective and thus almost impossible to standardize. However, given their pervasiveness there is merit attempting to gauge their severity in as objective a manner as possible in order to track disease progress and response to treatment. GRS can be widely irregular and requiring patients to call into the office to answer questionnaires post treatment or keep handwritten logs to turn in later can lead to inaccurate data collection that can hinder accurate diagnosis and management. The ubiquitous nature of smartphones and user-friendly interfaces of electronic applications allow for information to be logged/accessed remotely and securely, each log would have their own time stamp and be recorded in an organized, consistent manner.

Eligibility Criteria:
Inclusion/Exclusion for gas and bloating subjects:

Inclusion:

1. Anyone 18 to 80 years of age, inclusive with gas-related symptoms (GRS) such as gas and bloating, plus any of the following: distension, diarrhea, and/ or abdominal discomfort.
2. Normal upper endoscopy, normal colonoscopy (\<5 years) if patient is \> 50 years of age, normal computerized abdominal tomography scan, or a normal right upper quadrant scan

Exclusion:

1. Women of childbearing age will be asked if they are pregnant, and a negative response will be sufficient. No pregnancy test will be performed.
2. History of previous GI surgeries (except for cholecystectomy, hysterectomy, and appendectomy)
3. Significant co-morbid medical conditions, including stroke, COPD( Chronic Obstructive Pulmonary Disease) and cancers (except for non-melanotic skin cancer)
4. Recent hospitalization within 30 days of enrollment in this study
5. Recent History (within 4 weeks) of antibiotic use
6. Recent History (within one week) of a colonoscopy or barium study

Inclusion/Exclusion for healthy subjects:

Inclusion:

1. Anyone 18 to 80 years of age, inclusive with no medical problems and a negative bowel disease screening questionnaire.
The Effect of Music on Postoperative Anxiety

In this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety.

Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 80 patients scheduled for total knee arthroplasty surgery for will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into two groups as listening patient preferential music, and control. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones.Secondary aim is to assess the effect of listening patient preferred music on Quality of recovery, postoperative pain, MCID (minimal clinically important diffirence), patient and surgeon satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Undergo Total Knee Arthroplasty Under Spinal Anesthesia

Exclusion Criteria:

* Poor vision
* Significant hearing loss
* Dementia
* Active opioid use
* Regular use of anxiolytics or discontinuation of them on the day of surgery
* Unwillingness to participate in the study
* Unwillingness to listening to music
An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group.

Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations.

In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.

The purpose of this project is to set up an international, multicenter registry of patient presenting with defects in long bones. Up to date, treatment remains challenging with little evidenced-based recommendations.

For this purpose, any patient who presents at a study center with a bone defect of the defined expansion of any long bone is eligible for inclusion. Over a 3-year period as many patients as possible are included from the participating sites, at least 600 patients should be included in the registry. Details on any surgical intervention that is used to treat a bone defect will be recorded. Further patient-related and other pre-defined outcome measures will be collected.

There is no formal hypothesis to this registry, hence it will help to identify prevalence and underlying etiologies, evaluate treatment strategies, and highlight possible challenges and complications - and will so help to gather clinical evidence to provide better treatment for patients suffering from a long bone defect.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Skeletally mature
* Post traumatic bone defect \> 2 cm either

  * initially after injury or
  * after surgical debridement
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/ICF
  * Willingness and ability to participate in the clinical investigation according to the registry plan
  * Signed and dated EC/IRB approved written informed consent OR
  * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

Exclusion Criteria:

* Any oblique defect that has less than 8cm expansion when adding the defect size of all four cortices
* Any not medically managed severe systemic disease
* Pregnancy
* Prisoners
* Participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry
Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

The researchers think that the use of advanced MR imaging may help people with this disease, because it may better predict areas within a malignant glioma (brain tumor) that are at a high risk of recurring. WeThe reserchers are doing this study to see whether this advanced imaging is a safe treatment that causes few or mild side effects in people with brain tumors.


Eligibility Criteria:
Inclusion Criteria:

* Suspected or Histopathologically proven diagnosis of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation
* May undergo radiation therapy
* Patient and/or guardian is able to provide written informed consent prior to study registration
* Age ≥ 18 years old

Exclusion Criteria:

* Extreme claustrophobia that precludes MRI scan
* Known allergic reaction to Gd-DTPA
* Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
* Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
* Pregnant or nursing female
* Unable to cooperate for MRI and/or radiation therapy planning
Two Different Tactile Stimulus Methods

This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.

Objectives: This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.

Design: The study was conducted via a randomized controlled design. Setting: The study population consisted of children in the seven to 10 age group admitted to the emergency department of a public hospital (Kahta State Hospital) between February 2019 and July 2019 and who received an IM injection as part of the medical treatment.

Interventions: The study data were collected from the children, who were divided into Palm Stimulator, ShotBlocker, and control groups.

Main outcome measures: The children's pre-procedure fear levels were evaluated using the Children's Fear Scale (CFS), and their pain levels during the procedure were evaluated using the Facial Pain Scale-Revised (FPS-R). The children also reported injection-related pain levels using the Visual Analog Scale (VAS).

Eligibility Criteria:
Inclusion Criteria: children who

* had no diagnosed physical or mental disability or chronic illness;
* had no communication problems;
* received single injection,
* required Ampicillin + Sulbactam group of antibiotics for standardization; and
* received ventrogluteal muscle injection during the study.

Exclusion Criteria:

* Parents who were unable to collaborate in the fear and pain evaluation,
* overweight or underweight children (under the third or above the 97th percentile),
* children with any incision or scar tissue in the injection area,
* children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history
The Efficacy and Safety of SGF200 on Immune Enhancement

This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.

This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into SGF200 group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 50 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 3 months before first intake for test product
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Insulin Tolerance Test Study in Patients With Type 1 Diabetes

The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: Diagnosis of diabetes =\> 4yrs, On Insulin =\> 4yrs, HbA1c\<= 10%, At least one episode of severe hypoglycemia in past 12 months, fasting c-peptide \<0.7 ng/ml

Exclusion Criteria:

* Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet

The goal of this clinical trial is to assess the impact of combination therapy with Naltrexone-Bupropion (NB) in the post-operative period of sleeve gastrectomy (SG). on a) weight loss, b) resolution of comorbidities and c) eating behaviors.

Researchers will compare SG-NB group with SG-placebo group to see if they experience significantly higher excess weight loss (EWL) at 12 and 24 months and if there is a significantly higher percentage of patients with an EWL above 50% in the SG-NB group versus in the SG-placebo group.

Participants will be randomized 1:1 to SG in combination with NB versus SG with placebo. Patients will be started one month after surgery on a progressive dose of Naltrexone/Bupropion extended-release or placebo. Duration of therapy will be 24 months.Both groups will benefit from behavioral and nutritional support.


Eligibility Criteria:
Inclusion Criteria:

* MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.

Exclusion Criteria:

* Revisional or reoperative surgery
* Pregnancy or planned pregnancy in the next 24 months
* Simultaneous use of other weight loss medication
* Uncontrolled hypertension
* Chronic opioid use or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal.
* Use of other bupropion-containing products
* Concomitant administration of monoamine oxidase inhibitors.
* End-stage liver or kidney disease
* Concomitant use of CYP2B6 inhibitors (ticlopidine or clopidogrel)
* Concomitant administration of the antipsychotic thioridazine
* Seizure disorder or a history of seizures
* Cardiac pacemaker
* Current or prior diagnosis of bulimia or anorexia nervosa
Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis

An open-label study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Lupus Nephritis

Tamibarotene is a synthetic retinoid presently approved in Japan for the treatment of APL, and in US, Europe and China it is still under development for APL. Compared to other retinoid drugs available, Tamibarotene has not just a higher activity as a retinoid, but also shows a higher receptor selectivity towards the Retinoic Acid Receptor (RAR) subtypes alfa and beta, but not gamma. All trans retinoic acid (ATRA) and its derivatives are usually pan-agonists to these subtypes, and often are know for the irritation to the skin as one of their major side effects which is due to the RAR gamma subtype. Moreover, unlike ATRA tamibarotene does not cause induction of drug metabolism by CRABP.

Tamibarotene is known to moderate T1/T2 balance as well as Treg/Th17 balance through binding RAR-alfa receptor, and shows efficacy to various autoimmune and inflammatory animal models.

In the preliminary clinical research, patients with lupus nephritis for whom prednisolone treatment was not sufficient enough was treated with oral administration of ATRA to show a remarkable decrease in their protein urea (ref. Kinoshita et al, Am.J.Kidney Dis., 2009 Jul 21).

Based on these results, the investigators plan by this study to evaluate the efficacy of tamibarotene together with the safety to the patients of lupus nephritis.

Tamibarotene is used clinically in Japan since 2005. It's side effects are known to be similar to that of other clinically used retinoids.

Eligibility Criteria:
Inclusion Criteria:

* Steroid refractory lupus nephritis

  * more than 10mg of steroid failed to control disease activity
  * patients who failed to reduce the amount of steroid
  * patients who couldn't increase the amount of steroid due to side effects
* Urine Protein creatinine raio \> 0.5 or RBC in urine \>= 6 /HPF
* Anti dsDNA antibody \> 10 IU/ml or complement C3 \< 84 mg/dl
* Patients willing to take contraceptive measures throughout the study and for female patients two years after the study and for men six months after the study.

Exclusion Criteria:

* Pregnant or breastfeeding female patients
* Hepatic failure patients
* Triglyceride \> 500 mg/dl
* Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 8 weeks prior to test drug administration
* Patients who received cyclophosphamide puls within 6 months prior to test drug administration
* Patients with diabetics (HbA1c \> 8.0%)
* Serum creatinine ≧1.5mg/dL
* CNS( Central Nerve System) Lupus patients
Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients

Study design: Controlled Trial Objective: To evaluate the effectiveness of robotic-assisted training of forearm and hand functions in spinal cord injury patients Setting: Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Turkey Methods: Forty patients were allocated into robotic and control groups. Both groups received conventional rehabilitation program for four weeks. Moreover, robotic group received robotic rehabilitation program tailored to the patient five times a week (each session of 30 min).

Baseline data and post-intervention data was compared.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-50
* Cervical Level of Spinal Cord Injury

Exclusion Criteria:

* Severe upper extremity contractures in the joints
* Intensive spasticity (Ashworth 3-4)
* Shoulder pain that causes exercise intolerance
Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined exclusion criteria may apply.