cyrilzakka/clinical-trials huggingface dataset:
Cognitive Rehabilitation for PD

To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).

Eligible study participants will be randomly assigned to one of two interventions: 1) Cognitive Rehabilitation (Cognitive Symptom Management and Rehabilitation Therapy for Parkinson's disease; CogSMART-PD) or 2) Supportive Care. Interventions are held within a group format consisting of approximately 5 individuals with PD. Groups will meet once per week for 1.5 hours over a 10-week period. Neuropsychological testing will be administered pre- and post-intervention as well as 6- and 12-months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Mild Cognitive Impairment
3. Over 40 years of age
4. Fluent English speaker

Exclusion Criteria:

Other neurological conditions (e.g., stroke) besides Parkinson's disease
SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, when Administered as 30, 50, and 75 mg Once Daily for 12 weeks in Subjects with Chronic Hepatitis C-Related Thrombocytopenia who are Potential Candidates for Antiviral Treatment with Pegylated Interferon and Ribavirin.

Eligibility Criteria:
Inclusion criteria:

* Chronic low platelet count between 20,000 and \<70,000/µL.
* Prior liver biopsy indicating chronic hepatitis within the previous 5 years or radiographic evidence of cirrhosis and / or endoscopic evidence of non-bleeding esophageal or gastric varices.

Exclusion criteria:

* History of heart attack or abnormal heart function.
* History of thrombosis within 1 year.
* History of alcohol or drug abuse or dependence within 1 year.
* Use of aspirin, aspirin-containing compounds, salicylates, antacids.
* History of HIV infection or active infection with Hepatitis B or C.
* Females who are pregnant.
* Patients using non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.
Mesenchymal Stromal Cells for Ischemic Stroke

The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke.

This is a randomized, double-blind, placebo controlled study. . Approximately 48 subjects will be enrolled in the trial, undergo a real or SHAM MSC IV infusion and will be follow out to 1 year. There will potentially be 4 Cohorts with the dose escalation at a 3:1 randomization schedule

Objectives:

* The primary hypothesis' are that intravenous administration of allogeneic bone marrow derived mesenchymal stem cells is feasible and safe in patients with recent ischemic stroke and to determine the maximum tolerated dose (MTD) of IV MSCs when administered sub-acutely between 3-10 days following ischemic stroke.
* The secondary hypothesis is that allogeneic MSC transplantation will improve functional outcome after recent ischemic stroke.

Safety and clinical efficacy points to be evaluated at Day 7 clinic visit, Day 30, Day 60, Day 90, and Day 180. Primary outcome or Primary endpoint of the study is to define the safety or harm of the MSCs

Eligibility Criteria:
Inclusion Criteria:

1. acute ischemic stroke
2. age 18 to 83 years
3. post stroke mRS \> 3
4. NIHSS of 7-25
5. Deficits on the total NIHSS can be lower than 7 provided the patients have moderate aphasia or visual loss (2 on the Best Language or Visual loss NIHSS subcomponent) \*Criteria for mRS not used for this category of subjects
6. Last seen normal st within 3-9 days prior to stroke. Time of onset for wake-up stroke will be defined as the time the patient woke up with symptoms.
7. stem cell transplantation procedure must be performed between 3-10 days after stroke symptom onset

Exclusion Criteria:

1. Ischemic stroke, primary hemorrhagic or traumatic lesion of the brain or myocardial infarction within past 30 days prior to current stroke.
2. Mechanical heart valve
3. Uncontrolled seizure disorder, defined as a seizure within the last 6 months
4. Developmental delay
5. Chronic kidney disease
6. Hepatic disease or altered liver function
7. Pulmonary disease
8. Cancer within 5 years prior to study
9. Prior immunosuppression, including chemotherapy within last 3 years
10. Known HIV
11. Uncorrected coagulopathy or severe anemia
12. Pregnancy
13. Unable to undergo MRI or CT scan
14. Imaging shows clinically significant hemorrhage
Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption

Gabapentin, a structural analog of gamma aminobutyric acid (GABA), was introduced within the us as an anticonvulsant, used clinically to treat epilepsy. The drug causes amino acids release within the medulla spinalis dorsal horn and thus decreasing response to neural inputs and stabilizing the nervous activity. The mechanism of action of gabapentin on neuropathic pain is assumed to bind to the alpha 2 delta subunit of the voltage-dependent calcium channel within the central systema nervosum , reducing calcium influx into the nerve terminals and decreases the release of neurotransmitters like glutamate . Gabapentin, therefore, can be used for controlling chronic pain, as in diabetic neuropathy and other neuropathic disorders . Some studies examined the effectiveness of gabapentin for acute postoperative pain management for gynecological surgery, lumbar spinal surgery, arthroplasty, and thoracic surgery . A recent study concluded that gabapentin has a role in preoperative anxiolysis, attenuation of hemodynamic response to intubation, prevention of postoperative nausea and vomiting (PONV) and finally postoperative delirium . Up to date, the effect of preoperative gabapentin on inhaled anesthetic depth is unknown


Eligibility Criteria:
1. Inclusion criteria:

   * Patients aged from 18 to 60 years.
   * ASA I-II.
   * Undergoing craniotomy for intracranial tumors.
2. Exclusion criteria:

   * Patient refusal
   * Patients younger than 18 or above 60 years old
   * patients with (ASA) physical status ≥ III
   * patients with compromised cardiovascular, renal, hepatic or neurological function
   * Known allergy to study drug.
   * Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs
   * Suffered from severe psychiatric disease or drug addiction;
   * History of parenteral or oral analgesic intake within the last 48hours
Fluidotherapy in Patients With Distal Radius Fractures

Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.

Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase.

Reducing pain and edema after Distal Radius fracture is an important part of postoperative rehabilitation. Various massage and mobilization methods were applied to this patient population in the postoperative period. In a recent study evaluating the effectiveness of Whirlpool treatment, it was reported that studies on the effectiveness of fluidotherapy are also needed. There is no study in the literature evaluating the effectiveness of fluidotherapy in the postoperative rehabilitation program in patients who underwent surgery for distal radius fractures.

This study aimed to evaluate the effect of adding fluidotherapy to the early rehabilitation program on pain, edema, joint range of motion and functionality after the cast is removed in patients who received conservative cast treatment due to distal radius fracture.

Eligibility Criteria:
Inclusion Criteria:

-Treating with a cast due to distal radius fracture being over 18 years old

Exclusion Criteria:

* Presence of polytrauma
* History of previous limb-related surgery
* Hemiplegia in the involved limb
* Contracture in the involved limb
* Arterial and venous occlusions
* Lymphatic system disorders
* Heart and circulatory system disorders
* Hepatitis, Measles, Sepsis infectious diseases or fever
* Open wound on the applied hand.
Multicenter Cohort Prospective Study on Multidisciplinary Treatment of Rectal Cancer

The purpose of this study is to describe the diagnostic and treatment procedures employed for patients with rectal cancer in each participating center. Outcomes to treatment, costs of treatment will be described. Exploratory analyses will be done to identify factor that influence patient prognosis, as well as factors that predict patient response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis rectal carcinoma
* Signed informed consent

Exclusion Criteria:

* Refusal or incapability of providing informed consent
Management and Outcome of Scorpion Sting in Children

To determine the clinical characteristics of children with scorpion sting and implement guidelines for management of those children and observe the outcome

Scorpion envenomation is a severe,sometimes fatal medical condition especially in children .Worldwide,there are more than 1.2 million scorpion stings each year,mostly in tropical and subtropical regions.Every year,more than 420,000 snake bite,scorpion sting and spider bite incidents occur in the Middle East and North Africa (MENA).In the region of Assiut,in the South of Egypt,the annual incidence and mortality by scorpion stings has been reported to be 88 and 5.5 per 100,000 inhabitants.There are 1500 sub species of scorpions in the globe,and 50 of those have venom that is harmful to humans.The most toxic scorpion families are the Buthidae family.The MENA region is home to 27 species of scorpions from three families:theButhidae,Hemiscorpiidae,and Scorpionidae.Significant morbidity and mortality are caused by scorpion stings .In addition to local effectslikeredness,pain,burning,and swelling,scorpion venom exhibits variability among sub species and has a complex structure made up of neurotoxic proteins,salts,acidic proteins,and organic compounds.These components can cause neurological,cardiovascular,hematologic,and renal side effects.Because scorpion venoms are complex mixtures of several toxins,including cardiotoxins,nephrotoxins,hemolytictoxins,and neurotoxins,there is a possible danger of developing severe and frequently deadly clinical consequences.Heart failure and pulmonary edema are the main causes of mortality .As regards management of scorpion sting early antivenom treatment is recommended but its value remains controversial as it may cause anaphylactic reactions .Furthermore the majority of cases need supportive treatment to alleviate the cardiovascular effect.Cardiovascular symptoms respond well to vasodilators such as alpha-1blockers like prazosin.Prazosinis considered a physiological and pharmacological antidote to scorpion venom action.It antagonizes the after-effects of venom-liberated catecholamines.Since the use of prazosin with antivenom the recovery from scorpion sting has been hastened and mortality rate has been reduced from 30% to 1%.Uptill now there are no guidlines implemented at our hospital for the management of scorpion sting so that our study will aim at implementing guidelines for management of children with scorpion sting and observe the outcome of those children.The guidelines used are those recommended from the Egyptian ministry of health and Population with the addition of prazosin as many studies have concluded the benefits of prazosin

Eligibility Criteria:
Inclusion Criteria:

- All children under 18 years with definite history of scorpion sting

Exclusion Criteria:

* Children with no definite history of sting or more than 18 years
Diabetes Virus Detection Project, Intervention With GAD-alum

The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).

The aetiology of type 1 diabetes is unknown. Both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. Increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. New sensitive assays have been developed to detect these viruses and to study the immunological processes, especially T-cell function. Microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. This study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed classical type-1 diabetes
* Positive GAD antibodies
* Fasting C-peptide \>0.1 mmol/l
* Insulin dosage \>0.1 U/kg Bodyweight/day

Exclusion Criteria:

* Pregnancy
* Weaning
* Other chronic diseases than diabetes
* Any regular medication except oral contraceptives
* Psychiatric disturbances
Assessing the Benefits of a Painless Lancing Device Among Diabetes Patients

The purpose of this study is to assess the benefits of a painless lancing device among diabetes subjects in improving self-monitoring frequency and HbA1c compared to the conventional lancing device.

Self-monitoring of glucose forms the cornerstone of diabetes management. There are multiple limiting factors towards efficient self- monitoring of blood glucose, including cost barriers, inconvenience, investment of time, pain associated with pricking etc. Pain has perceived as a major impediment to the self-monitoring of blood glucose.

Genteel lancing device offers a painless pricking experience and hence helps to report blood sugar values at least 4 times a day. The perceived pain sensitivity of the study subjects would be assessed using the 4- point pain screening questionnaire during the course of the study.

The aim of this study is to gather information on the percentage reduction in HbA1c values in diabetes patients as compared to the baseline values after three months and six months respectively brought about by percentage SMBG adherence, defined as the percentage of total recorded SMBG values as compared to the ideal number of readings over the 24-week period. SMBG adherence = actual number of fingerpricks (6 times daily in type 1 subjects or twice weekly in type 2 subjects).

SMBG adherence can be provisionally attained by multiple pricking using painless Genteel lancing device compared to the conventional lancing device. Additionally, the subject is asked about the likelihood they would use the device if available for routine SMBG practice in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Less than or equal to 70 years of age. If minor (\<18 years), accompanied by caretaker.
2. Diagnosed with either Type 1 or Type 2 diabetes including newly diagnosed. 50% of the study participants will be type 1 diabetes subjects and 50% will be type 2 diabetes subjects
3. Presenting with an uncontrolled glycemic status (HbA1c \>8.0%).
4. Ready for Self-Monitoring of Blood Glucose (SMBG) practices.
5. Attending physician prescribed testing at least 2 times per day
6. Judged by the study trainer to be competent to correctly use Genteel AND demonstrated to the trainer that the subject can use the Genteel device properly.

Exclusion Criteria:

1. More than 70 years and less than 5 years
2. HbA1c \< 8.0%
3. Unwilling for SMBG.
The Comparison of Postoperative Pain After Colon Resection in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment

Colon resection is one of the major surgery, the postoperative pain is so severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain effectively. Consequently, it may result in the a lot of rescue analgesics use, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. And the patient's satisfaction to the PCA may be low.

For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects who undergoing colon resection due to colon cancer
2. ASA class Ⅰ-Ⅲ
3. Written consents obtained to participate voluntarily in this clinical trial

Exclusion Criteria:

1. Sudden change of surgical plan
2. Patients who have the hypersensitivity to the pain killers including narcotics
3. Patients who are unable to express the degree of pain
A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain

The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older;
* isolated traumatic injury to upper or lower extremity;
* alert and oriented to name, date, place; patient has a numeric pain score of 5 or higher;
* speaks English as their primary language;
* female patients are on birth control, menopausal, or are sterile (hysterectomy, tubal ligation)

Exclusion Criteria:

* injury isolated to a finger or toe;
* previous nasal or sinus surgery; chronic nasal problem;
* acute nasal problem (ie epistaxis, upper respiratory infection, sinusitis);
* pregnant; prisoner; allergy to sufentanil, fentanyl, or alfentanil; history of analgesic abuse or dependency;
* presence of other painful injuries; systolic Blood Pressure less than 100 mm Hg;
* patient seems or is confused or has a head injury; room air oxygenation less than 95%;
* patient has chronic obstructive pulmonary disease, severe asthma, oxygen-dependent pulmonary disease;
* impaired hepatic or renal function (obtained clinically or by history);
* weight more than 230 lbs (100 kg);
* alcohol or drug intoxication (per patient admission or clinical assessment of physician);
* elderly (\> 70 years)
Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

The main goal is to provide additional information to the risk-benefit assessment of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients who will undergo elective hip or knee arthroplasty.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes

This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female (females must be of non-childbearing potential), between the ages of 18 and 70 years, inclusive.
* Diagnosis of Type 2 diabetes.
* Fasted C-peptide value ≥ 0.8 ng/mL.
* HbA1c ≥ 6.5% and ≤ 10.0% for monotherapy cohorts (study drug only) or HbA1c ≥ 7.5% and ≤ 10.0% for combination cohorts (study drug and on a stable regimen of metformin monotherapy that includes a morning dose for ≥ 8 weeks prior to first dose of study drug).
* BMI ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2
* Additional criteria exist.

Key Exclusion Criteria:

* Recent history (i.e. less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, hepatic, psychiatric, neurologic, dermatologic or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), or other conditions at the discretion of the investigator.
* Significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia.
* History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
* A positive test for drugs or alcohol.
* Active infectious diseases including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Past history and inactive hepatitis B and C, as confirmed by serological testing, are allowed.
* Women who are pregnant or breastfeeding.
* Donation or loss of ≥ 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug.
* Additional criteria exist.