cyrilzakka/clinical-trials huggingface dataset:
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.

This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Males and/or Females between 18-65 years, inclusive.
* Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
* Have type 2 diabetes mellitus.
* On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.

Exclusion Criteria:

* Recent evidence or medical history of unstable concurrent disease.
* Cardiovascular event within 3 months prior to screening.
* History of renal transplant.
* History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.
Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

This study investigates the efficacy of neoadjuvant radiotherapy combined with QL1706 in MSS-type low-grade rectal cancer. This study is a prospective multicohort study, with cohort 1 intended to include patients with low grade early rectal cancer (cT1-3N0M0) and cohort 2 intended to include patients with low grade locally advanced rectal cancer (cT4N0M0 or cTanyN+M0). Each cohort included 30 subjects receiving neoadjuvant radiotherapy combined with QL1706 treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to receive neoadjuvant therapy.
2. Aged 18-75 years, regardless of gender.
3. Diagnosed with low-lying rectal adenocarcinoma (tumor located ≤7 cm from the anal verge) via colonoscopy, endorectal ultrasound, and pelvic high-resolution MRI, without distant metastasis.
4. Histopathologically confirmed rectal adenocarcinoma.
5. Good patient compliance, able to attend follow-up visits as required.
6. ECOG performance status score of 0-1.
7. Laboratory tests meeting the following criteria:

   i. WBC ≥3.5×10\^9/L, ANC ≥1.8×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥100 g/L.

   ii. INR ≤1.5, APTT ≤1.5×ULN, or PTT ≤1.5×ULN. iii. Total bilirubin ≤1.25×ULN; ALT/AST ≤5×ULN. iv. 24-hour creatinine clearance ≥50 mL/min or serum creatinine ≤1.5×ULN.
8. Voluntary signed informed consent.

Exclusion Criteria:

1. History of malignant colorectal tumors.
2. Patients requiring emergency surgery (e.g., intestinal obstruction, perforation, or hemorrhage).
3. Known allergy to capecitabine, oxaliplatin, PD-L1 inhibitors, CTLA-4 inhibitors, or related drugs.
4. Histopathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma.
5. Unstable systemic diseases, including but not limited to:

   Severe infection, uncontrolled diabetes, refractory hypertension, unstable angina, cerebrovascular accident, myocardial infarction, congestive heart failure, life-threatening arrhythmias, or severe hepatic/renal/metabolic disorders.
6. Conditions (e.g., psychiatric disorders, substance abuse) that may increase treatment risk, compromise compliance, or confound study results.
7. Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
8. Pregnancy, lactation, or refusal to use effective contraception during the study.
9. Other conditions deemed unsuitable by the investigator.
Synchronized Cardiac Assist for Cardiogenic Shock

The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.


Eligibility Criteria:
Inclusion Criteria:

Patients in cardiogenic shock in the setting of acute myocardial infarction

or

Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab.

Cardiogenic shock is defined as

* Systolic blood pressure \< 90 mmHg for at least 30 min or
* Inotropes are needed to maintain blood pressure \> 90 mmHg or
* Clinical signs of heart insufficiency with pulmonary congestion or
* Signs of end organ hypoperfusion with at least one of the following criteria:
* Altered mental status
* cold, damp skin or extremities
* oliguria (≤ 30 mL/h)
* serum lactate \> 2.0 mmol/L

Written consent of the patient or the legal caregiver

-

Exclusion Criteria:

* Age \> 85 years
* Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \> 10 min
* Coma with fixed pupils not induced by drugs;
* Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
* Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
* Fever (Body temperature \> 38.0 °C) or other evidence of sepsis
* Onset of cardiogenic shock \> 6 h before enrollment;
* Lactate \> 22 mmol/L;
* Massive pulmonary embolism;
* Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
* Previous known aortic regurgitation greater than grade II
* Contra-indications for anticoagulation
* Severe hemolysis of any cause
* Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
Diabetes Resistance Training Adaptations in Elderly

This study aims to verify the effects of resistance training on neuromuscular, vascular and functional adaptations of elderly diabetics type 2. Half of participants will be the intervention group that will perform resistance training, while the other half will be the control group that will perform stretching sessions.

Resistance training may be an interesting strategy to fight diabetes deleterious conditions, as it is known to increase muscle mass and quality, strength, functional capacity, vascular health, and decrease inflammation status and blood lipids, besides leading to improves in glycemic control. To test this hypothesis, 42 diabetic patients will be recruited and randomized to two groups that will be evaluated before and after 12 weeks of both intervention or control period. The resistance training group will perform all body resistance exercises three times per week, while the control group will perform a stretching session one time per week.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 60 yers and older
* HbA1c \> 6,5%
* BMI from 18,5 kg/m2 - 34,9 kg/m2

Exclusion Criteria:

* Current smoking
* Insulin users
* Hypertension uncontrolled
* Diabetic neuropathy
* Diabetic retinopathy
* Diabetic nephropathy
* Peripheral amputations
* Clinical depression
* Myocardial infarction (within past 6 months)
* Any unstable chronic condition
* Muscle-skeletal complications that limit the practice of the exercises
Study of SystemCHANGE-HIV

The purpose of this study is to assess a new behavioral intervention to help how people living with HIV/AIDS practice self-management skills. Specifically, we want to see if a new educational intervention can improve physical activity, sleep, mental wellness and quality of life in HIV(Human Immunodeficiency Virus)-infected men and women. We hypothesize that those who are in the intervention group will practice more self-management skills than those in the control group.

Sample: The study sample will include 40 HIV+ men and women. Inclusion criteria include: a documented HIV diagnosis; adult (18 years old or greater); and English speaking.

Design: The SystemCHANGE-HIV study will be a 15-week, randomized, two-group experimental design including a 10-week behavioral intervention. In the experimental group, one half of the participants (n=20) will receive the intervention; and in the control group, the other half of the participants will undergo usual care. Both the experimental and control group will complete the same psychometric instrument packet, three times, to give a comparison of self-management before and after intervention and at a four-week follow up visit. This packet includes information on medical history, demographics, HIV self-management,physical activity, social support, social capital, mental wellness, and quality of life.Additionally, all participants will wear an actigraph for seven consecutive days, at each data collection point, to assess sleep.

Analysis:Preliminary data analysis will include descriptive statistics and scatter plots to examine the distribution of each outcome at each time point, as well as each covariate of interest. Although our randomization scheme will ensure balance of baseline variables between the two arms (other than that due to chance alone), we will estimate the standardized magnitude of each baseline difference as well as the correlation between each baseline variable and each outcome of interest at 10 weeks or at 15 weeks to objectively determine baseline variables that will be needed to estimate the unbiased effect of the intervention on each outcome. The primary analysis will be based on intent to treat approach and will investigate the effect of the intervention on continuous outcomes at 10 weeks or 15 weeks. In particular, an Analysis of Covariance model will be used that adjusts for treatment arm and the baseline level of the outcome variable. Such a model will allow us to estimate the effect of the intervention on each outcome, adjusting for the baseline outcome.In addition, linear mixed models will be used to determine if the effect of the intervention on the outcome at 10 weeks differs from the effect of the intervention on the outcome at 15 weeks. If needed, all analyses will be repeated using an as-treated approach. All analyses will be performed using a two-sided significance of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* documented HIV diagnosis
* adult (21 years old or greater)
* English speaking

Exclusion Criteria:
A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-\[(diphenylmethyl) sulfinyl\] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Specific Aims:

1. Determine the safety of modafinil in the treatment of methamphetamine dependence.
2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
3. Assess the effect of modafinil on cognitive function in methamphetamine users.
4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.
5. Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.

Hypotheses:

1. Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
2. Subjects given modafinil will use less methamphetamine than subjects given placebo.
3. Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
5. Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years
* Patient is agreeable to conditions of study and signs consent form
* Fluency in English

Contact site for additional information.
THE EFFECT OF VIRTUAL REALITY APPLICATION ON PAIN, ANXIETY, AND COMFORT DURING CURETTAGE/DILATATION

The problems experienced by women at the stage of deciding to have a miscarriage, during and after miscarriage differ and their anxiety levels vary. It was determined that women experienced fear, thinking that they would sin, guilt, regret and indecision at the stage of deciding to abort. methods are used to relieve the pain and anxiety caused by interventional procedures in patients in direct proportion to the development of technology. Virtual reality (VR), one of these methods, is an innovative, up-to-date and unique application, combining reality and imagination with fictional technology.There is no study in the literature on the application of SG during curettage/dilatation procedure. This study was conducted to determine the effect of SG application on pain anxiety and comfort during curettage/dilatation procedure.


Eligibility Criteria:
Inclusion Criteria:

* 15-49 years old,
* Termination ordered,
* Can speak and understand Turkish,

Exclusion Criteria:

* - Cognitive, effective and without any problem preventing communication,
* No psychiatric problems,
* Diagnosed with epilepsy (due to the risk that SG glasses may trigger epileptic seizures),
* Women who volunteer to participate in the study will be recruited.
Effect of Forward Head and Rounded Shoulder Posture on Hand Grip Strength in Asymptomatic Young Adults

* see if there is significant difference between subjects with forward head rounded shoulder posture and subjects with normal posture in hand grip strength in asymptomatic young adults
* see if there is significant difference between subjects with rounded shoulder posture and subjects with normal posture in hand grip strength in asymptomatic young adults

* in forward head posture there is flexion in lower cervical vertebrae that causes tension on lower cervical nerve roots according to Harrison systemic review and these lower cervical nerve roots supply hand muscles
* also in rounded shoulder posture there is weakness in scapular stabilizers and retractors which affect proximal stability of the arm
* proximal stability is important for distal mobility
* so from this biomechanical point of veiw we conduct this study to see if forward head and rounded shoulder posture can affect hand grip strength in asymptomatic young adults.

Eligibility Criteria:
Inclusion Criteria:

66 subjects from both genders sedentary life.

* 22 subjects with rounded shoulder posture with the distance between on the table and the posterior aspect of lateral part of acromion process ≥ 2.5 cm
* 22 subjects with forward head rounded shoulder posture with craniovertebral angle ≤ 50 and the distance between on the table and the posterior aspect of lateral part of acromion process ≥ 2.5 cm
* 22 subjects with normal posture
* asymptomatic participants
* age range from 19-24 years old
* normal body mass index
* right handed subjects

Exclusion Criteria:

* • Neck or shoulder symptoms

  * Shoulder fracture
  * Shoulder dislocation
  * radiculopathy
  * Recent shoulder surgery
  * athletes
  * musculoskeletal abnormalities
TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques

The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative findings.

* This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
* All patients will undergo the following :

  1. History taking
  2. Clinical examination.
  3. For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.

Eligibility Criteria:
Inclusion Criteria:

1. History of previous cesarean section or hysterotomy.
2. Placenta previa with its lower edge covering the scar of previous cesarean section
3. From 28 wks to Full term.

Exclusion Criteria:

1. Multiple pregnancies.
2. Medical disorder as diabetes mellitus, hypertension.
3. Obese patients. BMI \> 30
4. Intrauterine growth retardation.
Anovo Surgical System in Ventral Hernia

The study is aimed to clinically assess the AnovoTM Surgical System in ventral hernia procedures. Extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old.
* Subjects able to provide written informed consent.
* Subject deemed eligible candidate by surgeon and will comply with the study procedures.
* Subjects with ventral hernia.
* Subjects with ASA grade I to III.
* Subject must sign and date informed consent prior to treatment.
* Subject can undergo general anesthesia per anesthesiologist assessment.

Exclusion Criteria:

* Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation.
* Subject has medical condition, which in the judgement of the investigator makes the subject a poor candidate for the investigational procedure.
* Participation in another clinical trial that is in the active phase.
* Subject unwilling or inability to follow procedures outlined in the protocol.
* Subjects who are not suitable for robotic surgery, the Subject will be excluded from the study and the will be considered a screen failure and the surgeon will proceed with a standard multiport laparoscopic Hernia repair.
* Subjects who present any adverse event before use the Anovo Surgical System ("Anovo") that can affect evaluation of safety and performance of Investigational Device.
Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

The aim of the study is to perform a randomized double-blind placebo controlled prospective study in newborn infants with MRI confirmed Middle Cerebral Artery (MCA) Perinatal Arterial Ischemic Stroke (PAIS) with darbepoetin. It will be investigated whether intravenous administered darbepoetin can induce the formation of neuronal tissue and restore brain function in neonates who suffered from PAIS compared to placebo treated controls. The ultimate goal of this study is therefore to develop a therapy using erythropoiesis-stimulating agents (ESA) such as darbepoetin to reduce or even prevent lifelong consequences of PAIS-related brain injury in this group of term newborns.


Eligibility Criteria:
Inclusion Criteria:

* Newborns ≥ 36+0 weeks of gestation, both male and female
* MRI confirmed diagnosis of acute PAIS, in the MCA region with involvement of the cortical spinal tract (e.g. Posterior Limb of Internal Capsule \[PLIC\] or peduncles) within one week after birth
* Written informed consent from custodial parent(s)

Exclusion Criteria:

* Moderate -severe Hypoxic-Ischemic Encephalopathy (HIE) with or without hypothermia therapy
* Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;
* Presence of a serious infection of the central nervous system;
* No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
* Infant for whom withdrawal of supportive care is being considered.
Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity

The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.

This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will be offered the EndoBarrier device after 12 months on study at the investigator's discretion if treatment of the device subjects indicates adequate efficacy. This study will be conducted at three (3) investigational sites.

The primary efficacy endpoint is:

* Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline between the two groups.

Secondary endpoints are:

* Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit from baseline.
* Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or discontinued at week 24 or last visit from baseline.
* Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from baseline.
* Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.
* Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12 months.
* Compare physical component summary (PCS), mental component summary (MCS) and quality adjusted life years (QALYs)via analysis of the SF-36v2 QOL.

Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM demonstrated an acceptable safety profile with clinically significant improvements in glycemic control and body weight when compared to a similar diet controlled group of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 65 years
* Male or Female
* Subjects with Type 2 Diabetes who have been treated for ≤10 years
* BMI\> 30 - \< 50
* Subjects with an HbA1c level \> 7.5 and ≤ 10.0%
* Subjects taking a combination of metformin and sulfonylureas and/or insulin (other than pre-mixed long and short acting insulins, ie. NovoMix 30)
* Patients willing to comply with study requirements
* Patients who have signed an informed consent form

Exclusion Criteria:

* Subjects taking oral medications to control their diabetes other than sulfonylureas and metformin
* Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
* Subjects on insulin \> 10 years
* Subjects requiring insulin \> 70 units per day
* Subjects on pre-mixed insulin (ie. NovoMix 30)