cyrilzakka/clinical-trials huggingface dataset:
TENS and Spasticity in Stroke Patients

study aims to evaluate the efficacy of high and low frequency TENS on spasticity, strength and functional status in stroke patients. It may provide further knowledge concerning the use of TENS for motor impairments in stroke patients and may clarify ambiguities to some extent.

Despite the positive effects of electrical stimulation proved on motor impairments of affected limb, the evidence is still not conclusive. There still remains a question mark regarding the effectiveness and optimal stimulation parameters of TENS. there has been conflict regarding the TENS parameters (frequency, duration, intensity) among different studies. To date TENS parameters used in different studies to reduce spasticity range from frequency of 1.7-100 Hz, duration from 15-60 minutes and sessions from 1-30. The use of different parameters may account for the contradictory results related to effectiveness of TENS.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female aged 40-70 years
* Middle cerebral artery (MCA) stroke
* 6 months after stroke
* Mini-mental state examination (MMSE)more than 24
* Modified Ashworth scale score between1 and 2

Exclusion Criteria:

* Patients with multiple sclerosis, spinal cord injury or with other pre-existing neurological disorders.
* Patients with orthopedic condition affecting upper extremity
* Patients with contraindication to TENS, like skin damaged etc.
POM-MP: PeriOp Metabolic & Mitochondrial Phenotype

Patients scheduled for bladder or bowel resection will receive assessments at three time points:

1. Preoperatively up to 30 days prior to scheduled surgery
2. Postoperatively in hospital up to 5 days
3. Postoperatively up to 30 days following scheduled surgery

At all time points the subjects will have blood samples drawn for mitochonrial function analysis and a muscle ultrasound (MuscleSound) performed. In addition, a cardiopulmonary exercise test (CPET or 'VO2 max') will be performed at the 30 day pre/post evaluation time points.

Cardiorespiratory fitness (CRF) is a measure of the efficiency to use oxygen. One method used to measure CRF is the cardiopulmonary exercise test (CPET), otherwise known as 'VO2 max'. Previous studies have shown that individuals assessed with CPET-derived parameters, such as VO2 max or anaerobic threshold (AT), below specific thresholds are at greater risk of post-operative complications, which can occur in up to 40% of surgical patients.

This study wants to determine if other methods of fitness or well-being, such as mitochondrial oxygen consumption and muscle ultrasound to determine muscle characteristics, can be combined with CPET assessment to improve the ability to identify surgical patients who develop postoperative complications, as measured by the validated tool, POMS.

The objective of the study is to create a method to identify the metabolic and mitochondrial phenotype of the perioperative patient, termed the POM-MP.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged \>18 undergoing bladder or bowel resection
* Able to speak English
* Ambulatory (assistive devices OK)
* Able to consent
* Willing to perform Cardiopulmonary Exercise Testing

Exclusion Criteria:

* Unable to perform CPET
* Pregnant
* Prisoner
* Patients with diagnosed Dementia
* Unable to ambulate independently
The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation

The main objective of this study is to evaluate, after surgery for chronic anterior shoulder instability using a Latarjet technique with positioning of the bone block via an SEM positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery in the decision to return to activity early as conditioned by the quality of the bone block consolidation.

The secondary objectives of this study are to assess:

A. the position of the block according to a shoulder scan at 3 months post-surgery

B. functional scores (Constant, Walch-Duplay) at 6 weeks, 3 and 6 months post surgery.

C. Complications: osteoarthritis, lysis of the block.

D. pain.

E. date of return to full activity.

F. patient satisfaction concerning care (visual analog scale at 6 months post-surgery).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient was operated for chronic anterior shoulder instability (defined by a history of at least two true dislocations and an ISIS score\> 2) 6 weeks ago (+/- 5 days)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients

This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.

Candidates will be screened with medical history and blood tests.Then, 2 groups of 20 patients (with or without CMV reactivation) matched for CMV status will be compared for their immune system against CMV.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18-year-old
* Informed consent

Exclusion Criteria:

* minors,
* pregnant or lactating women,
* adults under guardianship,
* immunosuppression at the entrance to resuscitation,
* AIDS
Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 14 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study

The purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.


Eligibility Criteria:
Inclusion Criteria:

* PSRA patients under 18 who were diagnosed at least one year prior to the study

Exclusion Criteria:

* PSRA patients under 18 who were diagnosed less one year prior to the study
* patients who do not fulfill PSRA criteria
* patients who fulfill Jones criteria
* patients with a known heart defect
A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without clinically significant medical conditions or laboratory abnormalities
* Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent
* Non-smokers
* Body mass index of 18.0 to 29.0 kg/m2 inclusive

Exclusion Criteria:

* Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.
* Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
* Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.
* Alcohol, drug, or medication abuse within one year before the study.
* Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
* Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.
A Randomised Comparison on the Dose Requirement Between, Levobupivacaine, Ropivacaine and Bupivacaine in Intrathecal Anaesthesia

To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and bupivacaine for 50% of patients in lower limb surgery


Eligibility Criteria:
Inclusion Criteria:

* body weight=40-90kg,
* height higher than 145cm

Exclusion Criteria:

* Known hypersensitivity to amide local anaesthetics,
* patients who do not understand English and Chinese,
* Body mass index higher than 35 kg per sq metre
Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset.

We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age of the patient.

Latanoprost is a topical ocular hypotensive medication with a well established safety and efficacy profile. Its effect is mediated by an increase in uveoscleral outflow, due to enzymatic degradation of the extracellular matrix within the ciliary muscle. Since the amount of extracellular matrix within the human eye increases with age, and uveoscleral outflow decreases with age, it would be expected that there should be a difference in the efficacy of latanoprost in patients of different ages. This has not been demonstrated in studies assessing the overall effect of latanoprost across adult age groups using multivariate analysis. (Camras CB et al, 1996).

However, a difference in timing of onset of drug effect may get overlooked in clinical studies and in clinical practice as well, as patients tend to be seen from two to eight weeks after initiation of treatment, by which time any differences in response time may have already occurred and leveled off.

To our knowledge, there are no studies specifically looking at the timing of onset of drug effect of latanoprost in different age groups. Because of the theoretical plausibility of this effect based on the mechanism of action of latanoprost, this represents an opportunity to further elucidate the characteristics of this medication in a manner which has clinical and scientific relevance.

Our aim is thus to determine if there is a difference in timing of onset of the ocular hypotensive effect of latanoprost in glaucoma patients of different age groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of open angle glaucoma,
* pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes;
* IOP above their target pressure as determined by a glaucoma specialist;
* willingness to participate in the study.

Exclusion Criteria:

* hypersensitivity to any of the components of the treatment medication;
* previous use of topical prostaglandins;
* documented ocular infection or intraocular inflammation within the past year;
* previous filtering surgery or complicated cataract surgery;
* active corneal disease;
* presence of cystoid macular edema;
* laser trabeculoplasty or any other ocular laser procedure within the past three months.
MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients

To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

Adenocarcinoma of the rectum, ability to understand written and oral information, written consent.

Exclusion Criteria:

Colon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.

This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.

Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.

* Measurable disease according to RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Able to provide the most recent archival tumor tissue samples.
* Adequate cardiovascular, haematological, liver and renal function.
* Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
* Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
* Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

Exclusion Criteria:

* Pregnancy, lactation, or breastfeeding.
* Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
* History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
* Participants with another invasive malignancy in the last two years.
* Participants with known active or uncontrolled infection.
* Positive HIV test at screening.
* Positive for Hepatitis B and C.
* Vaccination with live vaccines within 28 days prior to C1D1.
* Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion.
* Participants with wound healing complications.
* Dementia or altered mental status that would prohibit informed consent.
* History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
* Active or history of autoimmune disease or immune deficiency.
* Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
* Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
* Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).
A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection

Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.

A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with ribavirin in treatment-naïve participants with genotype 4 hepatitis C infection. The study will test the safety and effects of this alternative treatment for up to 12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic genotype 4 hepatitis C infection and HCV RNA ≥ 10\^4 IU/mL at screening
* Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening
* Absence of cirrhosis as defined by one of the following:

  * A liver biopsy performed within 24 calendar months of Day 1 showing absence of cirrhosis
  * Transient elastography (FibroScan®) performed within 12 calendar months of Day 1 with a result of ≤ 12.5 kPa
  * A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during screening

Exclusion Criteria:

* Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2
Neurofeedback and Working Memory Training for Children and Adolescents With ADHD

The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.

This study investigates two types of Neurofeedback (NF), one well-established and well-researched protocol called Slow Cortical Potential NF (SCP), and a newer and less researched, yet popular among private clinicians, the so-called live z-score training (LZT). These methods are compared to working memory training (WMT) and a passive control condition, treatment-as-usual only (TAU). The active conditions (SCP/LZT/WMT) are delivered high frequent, with 5 sessions/week, for a total of 25 sessions.

Outcomes measures are taken at Preintervention and Postintervention, as well as at a 6-month follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical AD/HD diagnose according to DSM-IV-TR and K-SADS interview, 9-17 years old, unmedicated or under stable medication with stimulants or corresponding since at least one month.

Exclusion Criteria:

* IQ \<70 (WISC-IV or WAIS-IV), clinically instable psychiatric state e.g. severe depression, OCD, self-injurious behaviour, bipolar disorder, severe somatic (neurologic) disease, very limited knowledge in the Swedish language.
A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection

The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks in patients with chronic hepatitis C genotype 1 infection.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be 18 to 65 years of age, inclusive.
* Primary diagnosis of chronic HCV infection.

Exclusion Criteria:

* Patients who did not respond or relapsed following therapy with interferon.
Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy

This study is to explore the relationship between intravenous infusion of dextrose during emergence from anesthesia and the incidence of PONV in patients undergoing gynecology laparoscopy (GL).


Eligibility Criteria:
Inclusion Criteria:

1. ASA I or II;
2. Performing gynecologic laparoscopic procedures under general anesthesia;

Exclusion Criteria:

1. age \<18 or \>75
2. severe hypertension,diabetes mellitus, significant hepatic or renal disease
3. inability to follow protocol
4. refusal to participant
Correlating the Measure of Retinal Vascular Density Through Angio-OCT with Calcium Score

Recent case-control studies have proven that the retinal vascularization mirrors the cardiac vascularization: more the coronary network is altered, more the density of retinal vessels is reduced. No studies have yet been realised in primary prevention. This study aims to demonstrate a link between the density of the retinal vascularization and the calcium score, which is currently the gold standard for the classification of cardiovascular risk in primary prevention. Thus, a simple image of the retinal vascularization could predict the cardiovascular risk of a patient. OCT angiography would become a major aid in the classification of cardiovascular risk in asymptomatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for a calcium score as part of their standard treatment and volunteers for an ophthalmologic consultation

Exclusion Criteria:

* Pregnant women
Trilostane for Androgen-Independent Prostate Cancer

The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.

* Patients will take trilostane orally once a day for three days, then twice a day thereafter.
* Patients will complete a daily drug log recording the date, time and number of capsules taken.
* Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
* While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
* Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
* Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* Disease progression despite androgen depravation therapy and antiandrogen withdrawal
* Progressive measurable disease or bone scan progression or PSA progression
* Serum total testosterone \< 50ng/ml
* Creatinine \< 2.0 mg/dl
* ALT \< 2 x ULN
* CALGB performance status of 0,1, or 2

Exclusion Criteria:

* Radiation therapy within 4 weeks
* Antiandrogen within 8 weeks
* Other secondary hormonal therapy or investigational agents within 4 weeks
* Prior chemotherapy for androgen-independent prostate cancer
* History of adrenal insufficiency
* Known brain metastases
* Severe liver or renal disease
Healthcare Cost and Resource Utilization Related to Metastatic Renal Cell Carcinoma Treatment With Intravenous and Oral Agents

A retrospective study to evaluate healthcare cost and resource utilization for patients with metastatic renal cell carcinoma who have been treated with IV or oral agents


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with metastatic renal cell carcinoma
* Prescription/administration of one of the IV or oral agents examined in the study

Exclusion Criteria:

* Patients with other primary cancer diagnosis before RCC diagnosis
* Patients with pregnancy or HIV/AIDS