cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.

The aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.

The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.

Eligibility Criteria:
Inclusion Criteria:

* STEPPAGE foot walking in a patient with a central neurological disease
* can walk for 50 meters with or without technical assistance
* stable disease for at least 1 year
* possible walk with a brace-type reliever
* verification of possible nerve stimulation
* age greater than or equal to 18 years and under 75 years
* no toxin for 4 months
* no alcohol for 6 months
* no neurotomy for 1 year
* patient who agreed to sign an informed consent to participate in the study

Exclusion Criteria:

* cons-indication to general anesthesia
* wearing a stimulator implanted for other reasons
* patients taking neuroleptics, benzodiazepines, or antidepressants or other drugs that interfere with the quality of walking
* advanced peripheral neuropathy
* excessive restriction of passive range of ankle
* poorly controlled epilepsy
* pregnant or lactating
* non-membership of a social security scheme
* wearing orthopaedic shoes including the malleolus
Intraperitoneal Lidocaine in Ovarian Cancer Surgery

The main objective of this trial is to improve the postoperative analgesia effect and prognosis of patients with ovarian cancer after laparotomy surgery. This is a randomized, double-blind, controlled trial to evaluate analgesia and patient outcomes after local peritoneal anesthesia after surgery.

This is a prospective, randomized, controlled clinical study. Sixty patients were expected to participate in a centralized randomized study method divided into two groups of 30 patients per group: the intraperitoneal analgesic group and the normal saline control group. Standard routine anesthesia was performed in both groups using the same method, and intravenous analgesia pump was routinely used in clinical use after surgery. The intraperitoneal analgesic group was continuously pumped with local anesthetics into the abdominal cavity, while the control group was pumped with normal saline. Visual analogue pain score (VAS), amount of remedial analgesia and use of analgesia pump were recorded at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours after operation. Record the time when the patient began drinking and eating, and the time when gastrointestinal function (defecation or exhaust) recovered. The time of starting to walk on the ground (including the time of needing attendant assistance or not) and the time of meeting the standard of postoperative discharge preparation. Perioperative peripheral blood samples were collected for five times (T0 before anesthesia induction, T1 after tracheal extubation, T2 on the morning of the first postoperative day, T3 on the morning of the second postoperative day, and T4 on the morning of the third postoperative day), and inflammatory factors and tumor-related indicators were monitored. Adverse reactions were recorded. The prognosis of the patients was followed up 5 years after operation.

Eligibility Criteria:
Inclusion Criteria:

* The American Society of Anesthesiologists (ASA) rated them as grade I to II, aged 18 to 75 years.
* Patients undergoing elective laparotomy for ovarian cancer reduction (surgical resection includes the whole uterus with or without double adnexa, lymph node biopsy, dissection, appendectomy, etc.).

Exclusion Criteria:

* Suffering from mental illness or unable to cooperate with pain and related index scoring, unable to use automatic pump.
* Peritoneal infection existed before surgery
* Past history of arrhythmia
* Severe liver and kidney dysfunction existed before surgery
* Known allergy to local anesthetics
* Do not agree to participate in the research
Ellipse Intramedullary High Tibial Osteotomy Nail Study

The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.


Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with the Ellipse IM HTO Nail System for osteoarthritis and varus malalignment of the knee
* Patient signs informed consent for the use of their personal private data.

Exclusion Criteria:

* Patient is currently enrolled in another clinical trial for high tibial osteotomy.
High Risk Populations Among COPD Patients in Japan

The patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary objectives are To explore the features of history of COPD exacerbations, symptoms, eosinophilic inflammation and patient background in patients with ACOS, to clarify the history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in patients with COPD. This is a cross-sectional study targeting COPD patients receiving outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and DBL would be locked by 3Q 2015.

Study Site(s), number of subjects planned Number of study sites planned for this research study (scheduled) 60 (undetermined) Number of subjects planned for this research study (scheduled) 1,100 patients

Eligibility Criteria:
Inclusion criteria

* Patients with a diagnosis of COPD (FEV1/FVC\<0.7 confirmed based on the past medical records)
* Patients aged 40 years and over at the diagnosis of COPD
* Outpatient
* 10 or more pack-years of current or former smokers
* Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year
* Patients who meet any of the following two criteria

  1. Patients who have medical records of the results of spirometry at more than two different time points excluding the time point of COPD exacerbations\* for the past 3 years
  2. Patients who can provide the results of reversibility testing for respiratory tract
* Patients who give written informed consent regarding the participation in this study

Exclusion criteria

* Patients currently with COPD exacerbations
* Patients who currently enroll in the other interventional study including clinical trials
* Patients who concurrently develop or have a history of lung cancer
* Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse)
Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder

The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of major depressive disorder
* Must be able to swallow tablets
* Must be at least 18 years of age.

Exclusion Criteria:

* Clinical diagnosis of other psychiatric disorders
* Significant risk of suicide
* Unstable medical conditions.
Pain Research: Innovative Strategies With Marijuana

This study tests the effects of cannabinoid levels in blood on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use edible cannabis. Over a two-week period, participants use an edible product of their choice. Blood levels of 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) will be measured before, during, and after the two-week exposure period to determine whether there are associations with pain, inflammation, sleep, physical activity, anxiety/depression, and cognitive dysfunction. After the two-week self-administration period, participants will be followed for six months to collect self-report data on cannabis use, pain levels, sleep quality, and mental health symptoms.

The National Center for Health Statistics reports that approximately 76 million Americans suffer from chronic pain, affecting the lives of more Americans than cancer, diabetes, and heart disease combined. Perhaps because of its ubiquity and the challenge to its treatment, relief from chronic pain is by far the most commonly cited condition by patients for use of marijuana, with 87%-94% of medical marijuana users reporting using for relief of a pain condition.

Although the mechanisms are still unclear, marijuana and its constituent cannabinoids, including 9-delta-tetrahydrocannabinol (THC), are thought to be involved in reducing pain and associated inflammation. However, THC is also associated with harm in the form of cognitive dysfunction. Synergistic interactions of multiple cannabinoids are believed to produce different effects on both pain relief and cognitive function as compared to THC alone. For example, cannabidiol (CBD) is another primary cannabinoid that may work synergistically with THC in a multi-target analgesic approach.

This study examines the effects of cannabinoids in edible form on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use marijuana in the context of a short-term (2 weeks), patient-oriented, observational design and a mobile pharmacology and phlebotomy lab.

Eligibility Criteria:
Inclusion Criteria:

* Intent to initiate use of marijuana to treat chronic pain
* At least one episode of lifetime marijuana use, but infrequent marijuana use for prior six months
* Self-reported non-specific chronic low back pain for at least three months
* Health eligibility approved by study physician
* At least mild to moderate pain intensity OR pain interferes with important life functions

Exclusion Criteria:

* Other drug use (cocaine, methamphetamine, etc.) in the past 3 days and/or actively seeking or in treatment for any substance use disorder
* Use of marijuana to treat pain at any time in lives
* Current use of psychotropic medications (other than SSRIs and ADHD meds), or use of antivirals, steroids, or regular use of maximal doses of NSAIDS
* A daily tobacco user
* Are currently pregnant or trying to become pregnant
* Acute illness (other than chronic pain) or any immune-related disease (e.g., HIV)
Prospective Randomised Study of a New an Uncemented Stem.

Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoartritis Secondary osteoartritis

Exclusion Criteria:

* Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated

Depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders

Eligibility Criteria:
Inclusion Criteria:

* a psychiatric disorder in which available treatment are either ineffective or not tolerated

Exclusion Criteria:

* implantable active devices
Evaluate Safety, Efficacy and Pharmacokinetics

The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Patients will receive CT-P6 or Herceptin.

Eligibility Criteria:
Inclusion Criteria:

* Are females
* Have a Her 2 over-expression
* Have Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

* Current clinical or radiographic evidence central nervous system (CNS) metastases
* Current Known infection
* Pregnant or nursing mother
Iron Status and Myelination in Premature Infants

Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.


Eligibility Criteria:
Inclusion Criteria:

* Babies less than or equal to 33 weeks gestational age

Exclusion Criteria:

* Infants with cranio-facial malformations
* Torch infections
* Infants with hearing disorders
* Infants receiving erythropoietin
* Infants with subnormal vitamin E levels
* Infants with severe anemia
* Infants who are not on full feeds
* Infant with in-utero exposure to cocaine
Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation

To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length 45-48mm)
* Single gestation
* Mean pulsatility index of the uterine arteries above the 95th percentile for our population

Exclusion Criteria:

* Pre-existing hypertension, renal or cardiovascular disease
* previous history of pre-eclampsia
* Pregestational diabetes
* Systemic lupus Erythematosus
* Gastric ulcer
* Acetylsalicylic acid or lactose hypersensitivity
* Bleeding disorders
* Fetal disorders (including chromosomal abnormalities)
* Administration of low molecular weight heparin
* Concomitant treatment with aspirin
Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas

The purpose of this study is adapt an evidence-based intervention for stigma-related stress, mental health, and HIV risk for bay, bisexual, and other men who have sex with men (MSM) of color in small urban areas.

This study has two specific aims. Aim 1 will focus on the modification of an existing intervention manual (created by the study PI) using feedback from previous qualitative interviews with MSM in New Haven and Hartford, CT. Also incorporated will be recent qualitative research on MSM of color's resilience. Specifically, the ways in which racial minority stigma impacts the mental health of MSM in small urban areas and adaptive coping skills that MSM can use in the face of these health threats.

Aim 2, will consist of the deliver of the adapted intervention to approximately 30 young MSM (15 HIV-negative and 15 HIV-positive) to gather data on the feasibility and acceptability of the newly adapted program. The evaluation of the new program will be conducted using pre-post comparisons of quantitative assessments and from qualitative interviews hoped to provide information regarding intervention feasibility, acceptability, and any needed refinement.

This project integrates expertise in culturally-sensitive evidence-based interventions for MSM's HIV risk into a community-based HIV prevention and care context at the Fair Haven Community Health Center, where the intervention will be delivered to the existing patient population.

As of April, 2019, the study protocol was updated and approved by the Yale IRB such that the two intervention cohorts did not differ by HIV serostatus. This decision was made: (1) because of the greater number of HIV-negative men, compared to HIV-positive men, who expressed interest in the study and (2) because participants could decide whether or not to disclose their serostatus in the group, as they do in other real-life interactions with other MSM, as reviewed during the consent process. Thus, there was no group assignment based on HIV serostatus.

Eligibility Criteria:
Inclusion Criteria:

Participants must:

* Report anticipated 6-month residential stability in New Haven county
* Self-identify as a gay or bisexual man or report being a man who has had past-12-month sex with a man
* Self-identify as an ethnic or racial minority, including Black, African American, Caribbean American, Hispanic, and Latinx
* Speak fluent English

Exclusion Criteria:

* Participants not meeting the inclusion criteria will not be eligible to participate.
Clinical Pharmacist Anticoagulant Stewardship

Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.

The Hadassah Hebrew University Medical Centers' Clinical Pharmacy team initiated a hospital-wide program, in collaboration with the institutions' coagulation specialists, including two hematologists and a clinical pharmacologist, for monitoring and promoting safe and effective prescription of direct oral anticoagulants (DOAC) during hospitalization. Electronic medical records throughout the hospital are screened for DOAC orders. All DOAC orders are assessed by a clinical pharmacist for potentially-inappropriate prescribing. When potentially-inappropriate prescribing or a drug-related problem is identified, the clinical pharmacist provided consultation on management options. In specific cases, additional guidance is provided by coagulation specialists. Consultations are recorded in the electronic medical record. Performance measures are collected and summarized.

Eligibility Criteria:
Inclusion Criteria:

Patients hospitalized in Hadassah Medical Center with a physician's order for direct oral anticoagulants (apixaban, rivaroxaban, or dabigatran).

Exclusion Criteria:

Patients hospitalized in departments without computerized physician order entry.
D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.


Eligibility Criteria:
Inclusion Criteria:

* suspected deep vein thrombosis
* history of previous DVT or PE

Exclusion Criteria:

* comorbid condition limiting survival to less than 6 months
* contraindication to contrast medium (allergy, renal dysfunction, creatinine \> 150mcmol/L)
* receiving long-term warfarin or heparin therapy
* received full-dose heparin therapy for more than 48 hours
* pregnancy
* symptomatic for pulmonary embolism
* absence of symptoms within 5 days of presentation
* geographic inaccessibility which precludes follow-up
Impact of Bevacizumab on Symptom Burden and Neurological Deficits in Patients With Recurrent Glioblastoma

This retrospective non - interventional patient chart review will be utilizing real world clinical data from patients treated for rGBM at the University Regensburg Medical center either with or without bevacizumab. Only patients will be analyzed who were potentially eligible for bevacizumab treatment. The study is designed to investigate the potential effects of bevacizumab treatment on the functional status, symptom burden, neurological deficits, time to tumor progression and overall survival between cohorts potentially eligible for bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of recurrent glioblastoma

Exclusion Criteria:

Severe neurocognitive deficits
Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir

A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.

Bioequivalence of the new valcyclovir formulation will be tested according to the EMA guideline for bioequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 and not older than 55 years of age at screening.
* Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing
* Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject has signed the Informed Consent Form prior to screening evaluations.
* Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
* Subject has a normal blood pressure and pulse rate, according to the investigator's judgement.
* Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or is of childbearing potential with adequate contraception (e.g. hysterectomy, bilateral tubal ligation, (nonhormonal) intrauterine device, total abstinence, double barrier methods, vasectomized partner).

Exclusion Criteria:

* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Positive HIV, hepatitis B or C test.
* Therapy with any drug (for two weeks preceding dosing), except for acetaminophen.
* Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to the first dose.
* Donation of blood within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose.
* Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the first dose) or breast-feeding female.