cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18-80 yrs
* Lower limb spasticity
* Time since stroke greater than 3 months
* Need for 400 U Botulinum toxin type A

Exclusion Criteria:

* Body weight below 50kg
* Fixed contractures of the lower limb
* Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
* Infection at the injection site
Cerebral Oximetry As an Auxiliary Diagnostic Tool in the Diagnosis of Brain Death

Aim: To investigate the efficacy of cerebral oximetry (CO) as an auxiliary diagnostic tool in confirming brain death (BD).

Materials and Methods: This observational and interventional study was performed on patients with suspected BD in emergency departments and intensive care units. CO monitoring was performed for at least 6 h, and cerebral tissue oxygen saturation (ScO2) was recorded. Basal ScO2 values (basal ScO2), ScO2 values after 6 h (end ScO2), mean ScO2 values during monitoring (mean ScO2), and minimum (min ScO2) and maximum (max ScO2) ScO2 values observed during monitoring were recorded for all patients. Patients with diagnosis of BD confirmed by the organ transplantation and brain death committee were enrolled as the BD group and other patients as the non-BD group, and cerebral oxygen parameters were compared.

Brain death (BD) means the irreversible loss of all brain and brain stem functions and physiopathologically the cessation of intracranial circulation. BD is a clinical diagnosis that can be made with various clinical tests. However, in order for BD to be definitely established, clinical tests performed initially need to be repeated after 24 h or to be confirmed by corroboratory tests. In addition, the obligation to confirm BD using corroboratory tests varies in current guidelines from country to country but has been eliminated except for certain specific circumstances. However, considering the adverse effects on patients awaiting donor and organ donations of the time lapse between initial and repeat tests in order to confirm BD, more rapid confirmation of definite BD is commonly made using corroboratory tests.

This study was planned with the hypothesis that this non-invasive technique using NIRS technology can be an auxiliary tool in the diagnosis of BD.

This study was performed with patients with suspected BD in emergency departments and intensive care units and was intended to evaluate the effectiveness of cerebral oximetry as an auxiliary diagnostic tool in patients with suspected BD.

Eligibility Criteria:
Inclusion Criteria:

1. All patients monitored and treated in the emergency department of intensive care units with a GCS score of 3 and evaluated as brain-dead at consultation with the Organ Transplantation Brain Death Committee on suspicion of BD
2. Aged over 18 years

Exclusion Criteria:

1. Cause of coma being undetermined
2. Lack of confirmation of brain injury being diffuse and irreversible
3. Central body temperature being lower than 32°C
4. Presence of a picture of hypotensive shock
5. Coma after drug effects and intoxications
6. Presence of metabolic, electrolyte or acid-alkaline disorders
Safety Study of AMG 557 in Subjects With Lupus Arthritis

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
* Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;
* Other inclusion criteria may apply.

Exclusion Criteria:

* Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
* Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
* Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
* Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
* Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
* Other exclusion criteria may apply
Sleep and Girls' Emotions Study

This study evaluates whether increasing sleep duration can increase neural and behavioral response to rewards and decrease depressive symptoms in 18- to 22-year-old women with insufficient sleep and depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Insufficient sleep (total sleep time \< 8 hours per night, with sleepiness scores ≥ 6 on the Epworth Sleepiness Scale OR ≥ 16 on the PROMIS Sleep Related Impairment Scale)
* Symptoms of depression (≥ 15 on the Center for Epidemiological Studies for Depression Scale)

Exclusion Criteria:

* Current insomnia, hypersomnia, sleep disordered breathing, sleep movement disorder, or circadian rhythm disorder
* History of head injury with loss of consciousness within the past two years
* History of head injury with loss of consciousness two or more years ago and meet criteria for post concussion syndrome
* Neurological disorder
* Use of psychiatric medications
* Current psychotic symptoms
* Active suicidal ideation
* Conditions that are contraindicated for MRI (e.g., ferromagnetic material in the body)
* Meet criteria for current substance use disorder with greater than mild severity
Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :

1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.

Participants will undergo routine postoperative care:

1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
2. Postoperative visit twice a day for at least seven days


Eligibility Criteria:
Inclusion Criteria:

* elective surgery for lobectomy or segmentectomy

Exclusion Criteria:

* local allergy to anesthetics;
* patients with a clear preoperative history of nervous system and mental system diseases or long-term use of sedatives or antidepressants;
* history of alcoholism, drug abuse or drug dependence;
* have a history of brain surgery or injury;
* epilepsy and associated mental and cognitive dysfunction, long-term stress stimulation, or psychological disorders;
* sick sinus syndrome, second-degree or greater atrioventricular block or other contraindications for use of α2 adrenergic agonist;
* liver and kidney insufficiency.
Early Detection of Disability and Health Promotion for Community-dwelling Elderly

This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.

Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality.

Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 50 years
* able to follow simple instructions
* willing to participate and sign consent form

Exclusion Criteria:

* unstable angina or epilepsy
* severe visual deficits
* cognitive dysfunction
* other musculoskeletal conditions that will limit mobility
Comparison Between Primary and Secondary Implant Stability of Hybrid Versus Resorbable Blast Media (RBM) Surfaces Using Resonance Frequency Analysis

• To compare primary stability (during initial loading of implant) and secondary stability (after 12 weeks of implant loading) which are denoted as ISQ value of Hybrid (DIO UFII) versus Resorbable blast media (RBM) (Osstem TSII) implant surfaces.

An approval from the hospital ethical committee will be obtained for this study. As a protocol all patients presenting to Institute of Dentistry, CMH Lahore Medical College will be examined in general OPD and those patients who fulfill the inclusion and exclusion criteria will be referred to Prosthodontics department. After history, complete oral examination and informed consent. Patients will be divided into two groups by lottery method; In Group 1 Hybrid (sand blasted acid etched implants) will be place. In Group 2 Resorbable Blast Media (RBM) implant surfaces will be placed. On the basis of randomized study the patients will be selected for the study to measure implant primary stability with a resonance frequency analyzer at the time of initial loading of implant, starting with an assessment immediately following implant placement with insertion torque of 30 Ncm and then secondary stability at 12 weeks post operatively by using Ostell Mentor. This instrument on each implant by inserting a standardized abutment (Smartpeg) of fixed length into each implant. The transducer probe (Osstell mentor probe) will be held so that the probe tip was aimed at the small magnet on top of the Smartpeg at a distance of 2-3 mm in both the buccal and lingual directions, and the mean of these measurements will then be calculated. The probe will be held still during the pulsing time until the instrument beeped and the displayed the ISQ value. ISQ1 will be evaluated immediately during initial implant loading which will be primary stability and ISQ2 will be evaluated after 12 weeks of implant placement when implant is properly osseointegrated, which will be secondary stability of an implant.

The implant fixtures will be DIO UF II for the Hybrid implants and the Osstem TSII plus system for the RBM implants. Data would be stratified for age, gender and implant site to address the effect modifiers.

Eligibility Criteria:
Inclusion Criteria:

* o Age between 20 to 50 years.

  * Both male and female patients will be selected.
  * Patients suitable for implant restorations on CBCT will be diagnosed by;

    1. Bone height (minimum of 12mm)
    2. Bone width (minimum of 5mm)
    3. Proximity with vital structures (nerves, blood vessels)

Exclusion Criteria:

* o Patients with diabetes, Parkinson's disease, myasthenia gravis and bulbar palsy

  * Diseases with either a strong connection to emotional stress or impairing mental health like depression, anxiety, sleeping disorder on history examination.
  * Patients with poor oral hygiene.
  * Patients with parafunctional habits of severe clenching habit, bruxism.
  * Heavy smokers
  * Patients who had undergone radiotherapy or chemotherapy.
  * Patients with osteoarthritis, osteoporosis.
  * Patients taking bisphosphonates
A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with sorafenib versus treatment with sorafenib alone in subjects with metastatic hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to assess overall tumor response rate and evaluate disease progression

Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment. This trial will study an intravenous Vitamin C treatment for persons with liver cancer that has spread, who are also receiving Sorafenib (a standard cancer drug), to see whether the combination of Vitamin C and Sorafenib is safe and well tolerated. Phase I will involve 6 persons who will receive the Vitamin C for 8 weeks to more specifically assess the safety of getting Vitamin C in combination with Sorafenib. Phase II will be randomized to receive either Vitamin C plus Sorafenib or Sorafenib alone for 16 weeks. If Vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Metastatic hepatocellular carcinoma
* G6PD (glucose-6-phosphate dehydrogenase) status \> lower limit of normal
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper limit (if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine clearance will be obtained); transaminase (AST/ALT) ≤2.0X upper limit of normal; bilirubin levels ≥ 2 mg/dL; ANC ≥1,500/mm3; Hemoglobin \> 8g/dL; platelet ≥ 100,000/mm3
* Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study.
* Willing and able to provide informed consent and participate in the study procedures.

Exclusion Criteria:

* Patients with evidence of a significant current psychiatric disorder that would prevent completion of the study as determined by the PI will not be allowed to participate.
* Co-morbid medical condition that would affect survival or tolerance as determined by the PI. This includes patients who have not fully recovered from toxicities associated with prior therapy. It also includes subjects who, as determined by the PI, are at risk of experiencing fluid overload (i.e., congestive heart failure).
* Patients who currently abuse alcohol or drugs.
* Patients with known glomerular filtration rate of \<60ml/min or with nephrotic range proteinuria.
* Pregnant or lactating women
* Enrollment in active clinical trial/ experimental therapy or IND study within the prior 30 days.
* Contraindication for CT or PET/CT as per the PI.
Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice

Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.

Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.

Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.

Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.

In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.

Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.

Cluster randomised pragmatic controlled trial in general practice

Eligibility Criteria:
Inclusion Criteria:

* Treated High blood Pressure patients with at least two other cardiovascular risks

Exclusion Criteria:

* Secondary prevention
Transfusion Strategies in Pediatric Cardiothoracic Surgery

The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.

Objective: To compare mean post-operative arterial lactate levels, oxygen utilization, and outcome measures in pediatric patients undergoing cavopulmonary connection managed with two different red blood cell transfusion strategies.

Methods: We propose a prospective, randomized clinical trial of sixty-six pediatric patients with cyanotic, complex congenital cardiac disease undergoing cavopulmonary connection as their operative repair. Thirty-three patients will be randomly assigned to a low Hb strategy of transfusion, in which red cells are transfused if the hemoglobin concentration falls below 9.0 g/dL, and hemoglobin concentrations are maintained about 8.5 g/dL. Thirty-three additional patients will be randomly assigned to the high Hb transfusion strategy, where red cells are transfused if the hemoglobin concentration falls below 13.0 g/dL, and hemoglobin concentrations are maintained about 12.5 g/dL. The primary endpoint will be comparison of mean arterial lactate levels from 8 to 72 hours post-operatively. The secondary endpoints will be oxygen utilization reflected by the arterio-venous oxygen difference (AV-difference) and arterio-cerebral oxygen difference (AC-difference). Measures of oxygen utilization will be derived from arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), and cerebral oxygen saturation (ScO2) collected at various time points throughout the study. Tertiary outcome measures will be length of mechanical ventilation, length of oxygen use and of vasoactive agent administration, length pediatric cardiac intensive care unit (PCICU) admission, volume of blood transfused, and mortality. Data from each group will be compared using analysis of variance to assess for the presence of a difference between the two transfusion strategies. If a significant difference between the two groups exists, T-tests will be performed to compare data points between each group to assess for a significant difference.

Hypothesis: A more restrictive (low Hb) strategy of red cell transfusion will be as effective as, and possibly superior to, the historical (high Hb) approach. Allowing a lower Hb concentration will decrease RBC donor exposure and may decrease the known complications of RBC transfusions. We postulate that no significant difference will exist between the two transfusion groups in regards to hemodynamic and cardiopulmonary status (as evidenced by mean lactate levels) and oxygen utilization.

Eligibility Criteria:
Inclusion Criteria:

* 4 months to 6.99 years of age
* surgical candidates for cavopulmonary connection
* English speaking

Exclusion Criteria:

* presence of known bleeding disorder
* presence of known coagulopathy
* age \< 4 months
* age \> 7 years
* non-English speaking
Lung Function Tests in Adolescents With Anorexia Nervosa

The investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa.

Anorexia Nervosa in adolescents holds adverse effects on different body systems as the cardiovascular, central nervous, endocrine, bone and gastrointestinal systems. There is paucity of information regarding the adverse effects of this tenacious illness on the lungs of adolescents at the hypocaloric stage of their illness. Based on previous clinical observations we postulate that lung function tests would be adversely effected by the hypocaloric nutrition of adolescents with anorexia nervosa and that they may improve during short refeeding in an inpatient setting of a general pediatric ward. To examine our hypothesis we would check lung function by various parameters of adolescents suffering from AN and a control group of adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with anorexia nervosa
* Ability to preform lung function tests
* Parents signing informed concent and adolescents signing informed ascent

Exclusion Criteria:

* A history of a lung disease
* Intercurrent lung illness