cyrilzakka/clinical-trials huggingface dataset:
EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease

The main goal of this study is to evaluate, via EMG (electromyography) system, the muscle activity in the lower limbs, to understand the contribution of the muscle activity to FOG (freezing of gait) in Parkinson's patients. The phenomenon of FOG appears in advanced cases of Parkinson's disease (PD) and can lead to an increased risk of falls. There are several approaches claiming that there is abnormal activity in the calf muscles and the freezing events in Parkinson's patients. In the clinic, monitoring FOG is done subjectively, usually through observations or through questionnaires. As a result, the information about the phenomenon may be biased and insensitive. With an electromyographic monitor (EMG), objective information about the muscular activity during normal walking and during unusual events can be obtained.

The subject will arrive independently at the Tel Aviv Medical Center. After explaining the course of the study and signing a consent form, the subject will be administered the MoCA questionnaire to assess the cognitive state.

During this session, the patient will undergo gait evaluation using motion sensors and an EMG device.

This meeting will last up to an hour, according to the following breakdown:

Explanation of the test (10 min) Preparing the skin (light disinfection with alcohol) for EMG adhesion (10 min.) Performing of the test (20 minutes) Summary and discharge (5 min).

Eligibility Criteria:
Inclusion criteria for patients:

1. Men and women aged 40-89.
2. Patients with idiopathic Parkinson's disease according to the diagnosis of a neurologist, who are able to walk with or without a walking aid for at least 5 minutes.
3. 21 or above in MoCA test.
4. people who gave their written and oral consent to participate in the study.

Inclusion criteria for healthy people:

1. Men and women aged 40-89.
2. 24 or above in MoCA test.
3. Without a neurological, cardiovascular or orthopedic disorder, which could affect the normal walking pattern, and all within the researcher's decision.

Criteria for exclusion from the experiment:

1. The patient has serious side effects that are not suitable for continuing in the study.
2. The patient does not wish to continue his participation in the study.

Exclusion criteria for Parkinson's patients:

1. Neurological or other psychiatric disorder (such as MSA, PSP, after a stroke with neurological signs, dementia diseases, clinical depression) at the researcher's decision.
2. History of head injury - traumatic brain injury or cerebrovascular accident (CVA)
3. This study will not include pregnant women and children.
Pilot Study of Haploidentical Natural Killer Cell Infusions for Poor Prognosis Non-AML Hematologic Malignancies

The prognosis of pediatric patients with hematologic malignancies whose disease is primarily refractory or those who experience a chemotherapy resistant bone marrow relapse is extremely poor. When new agents or chemotherapeutic regimens are unable to induce remission in this patient population, hematopoietic stem cell transplant (HSCT) is also a poor alternative. Thus, in this very high risk group, additional attempts at remission induction with various combinations of chemotherapy alone will unlikely improve outcome and will contribute to overall toxicity. Alternative therapies are needed in these patients with chemotherapy resistant disease.

Immunotherapy with natural killer (NK) cell infusion has the potential to decrease toxicity and induce hematologic remission. NK cells can kill target cells, including leukemia cells, without prior exposure to those cells. In patients undergoing allogeneic HSCT, several studies have demonstrated the powerful effect of NK cells against leukemia. Furthermore, NK cell infusions in patients with primary refractory or multiple-relapsed leukemia have been shown to be well tolerated and void of graft-versus-host disease effects. In this high risk group, complete leukemic remission has been observed in several of these patients after NK cell infusion.

With the current technology available at St. Jude, we have developed a procedure to purify NK cells from adult donors. This protocol will assess the safety of chemotherapy and IL-2 administration to facilitate transient NK-cell engraftment in research participants who have chemotherapy refractory hematologic malignancies including acute lymphoblastic leukemia, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, or non-Hodgkin's lymphoma. In this same cohort, we will also intend to explore the efficacy of NK cells infused in those participants who have chemotherapy refractory disease.

This study will evaluate the persistence, phenotype and function of donor NK cells as well as exploring the efficacy of the infusion in research participants with chemotherapy refractory hematologic malignancies.

Eligibility Criteria:
Inclusion Criteria:

* At least two weeks since receipt of last biological therapy, chemotherapy, or radiation therapy.
* Has a suitable adult family member donor available for NK cell donation.
* No current pleural or pericardial effusion.
* HIV negative
* Adequate clinical standing as evidenced by being within multiple renal, hepatic, pulmonary, and neurological required testing parameters.

Exclusion Criteria:

* Pregnant or lactating
Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation

New extended depth of focus intraocular lenses (IOLs) are being used in a broader spectrum of patients than trifocal IOLs. The purpose of this study is to evaluate visual improvement after cataract surgery in patients with glaucoma or ocular hypertension undergoing simultaneous cataract surgery with i-Stent implantation with the implantation of a Vivity IOL. Results will be compared with a group of glaucoma or ocular hypertension undergoing isolated cataract surgery with Vivity implantation, as well as with patients with no pathology undergoing cataract surgery and Vivity implantation

The purpose of this study is to report in detail visual function and patient satisfaction, as well as the need for spectacle correction, in patients with glaucoma and ocular hypertension undergoing cataract surgery with bilateral implantation of an extended depth of focus IOL, the Vivity IOL. The study also seeks to determine if there are differences in the speed of visual improvement between patients undergoing isolated cataract surgery and patients undergoing simultaneous i-Stent implantation. Results will also be compared with a group of patients with no ocular pathology undergoing cataract surgery with Vivity implantation.

Patients will be asked to join the study once the type of surgery (isolated phacoemulsification versus phacoemulsification combined with i-Stent implantation) and the type of lens to be implanted (monofocal, EDoF, trifocal) has been agreed between ophthalmologist and patient. Therefore, inclusion in the study will have no influence on surgical indication.

Once informed consent has been signed, the patient will be included in the study.

Explorations specific for the study will be performed 3 and 12 months after surgery and include:

Defocus curves Contrast sensitivity Self-reported photic phenomena Need for spectacle correction Satisfaction measured with the Catquest SF9 questionnaire

Besides study-specific procedures, the following explorations which are standard of care will be performed one day, one week and one month after surgery:

Uncorrected binocular visual acuity for distance, intermediate and near distances Monocular distance corrected and uncorrected visual acuity Residual subjective refraction Slit-lamp examination Intraocular pressure and number of hypotensive drugs required Description of any intra- or postsurgical complications

Eligibility Criteria:
Inclusion Criteria: Bilateral cataract surgery with Vivity implantation with or without i_STent implantation

Exclusion Criteria: Ocular disease other than glaucoma
SPC3649 Multiple Dose Study in Healthy Volunteers

The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine

To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.

All subjects who participated in the primary vaccination study, where subjects who received GSK Biologicals' hepatitis B vaccine and who will consent to participate in this long-term follow-up study, approximately 5 to 6 years after the primary vaccination study. The study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study.
* Written informed consent obtained from the subject for the long-term follow-up.
Early Versus Traditional Oral Hydration After Cesarean Section

this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs while the control group will get 200 ml of sugar free water 6 hours after cs

Traditionally, patients are not given fluids or food after cesarean sections until bowel function returns as evidenced by bowel sounds, passage of stool or flatus since , uneventful (uncomplicated) cesarean sections have no effect on intestinal functions and with putting in minds the need of the mother for early hydration , movement , breast feeding and early discharge; that is why we are investigating the effectiveness and safety of early oral hydration after cesarean sections

Eligibility Criteria:
Inclusion Criteria:

* Term Singleton Pregnancy.
* Uncomplicated Elective Cesarean Section.
* Time of Cesarean Section doesn't exceed 90 minutes.
* Average blood loss during and after cesarean section (doesn't exceed 1000cc).
* All patients will be under spinal anesthesia.

Exclusion Criteria:

* Postpartum Hemorrhage.
* Surgical Complications Such as intestinal injury.
* Medical disorders such as Diabetes and Hypertension
* Factors that may influence postpartum blood loss as anemia, multiple pregnancy and polyhydraminos.
* Use of tocolytic drugs
A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.

Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged at least 18 years at time of Screening.
* Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
* Other protocol defined inclusion criteria may apply. Please refer to the protocol.

Exclusion Criteria:

* Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
* Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they use effective contraception
Long Term Follow up Study of Predictive Markers in GHD and TS Children

Primary objective is to assess the relationship between changes from serum biomarkers observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner Syndrome (TS).

This study is an observational study that will collect data from patients enrolled in a previous study (PREDICT, NCT 00256126). Data such as auxological parameters (height, weight, Tanner stage, bone age will be collected as well as GH treatment use (including dose and adherence to the treatment).

Because for some countries the start of this long term follow up study will take place more than one year after subjects have completed the initial study (PREDICT) retrospective data may be collected (if subjects agree) as well as prospective data.

When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected.

This data will be collected yearly during the normal follow up visits during 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Have completed the PREDICT study (NCT 00256126)
* Followed up at least 1 year when still under treatment after completion of PREDICT Trial
* Parent's or guardian's written consent given before any data collection

Exclusion Criteria:

* Use of an investigational drug or participation in another interventional clinical trial since discontinuation of PREDICT trial
Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation

The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years.
2. Both genders.
3. American Society of Anesthesiologists' (ASA) physical status I or II.
4. Undergoing single level lumbar spine fixation.

Exclusion Criteria:

1. Patient refusal.
2. Pregnant females.
3. Renal, lung, heart, or liver disorders.
4. Communication difficulties which might prevent a reliable postoperative assessment.
5. Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics).
6. BMI more than 30 kg/m2.
A Community-based Advance Care Planning Programme for Patients With Advanced Disease

Advance care planning has been recommended as an integral part of care for patients with life-limiting disease, but relevant development in Hong Kong is still in its infancy. This proposed study attempts to address this service gap by promoting advance care planning to patients with advanced disease. It is hypothesized that the proportion of patients whose end-of-life care preferences were known in the experimental group will be significantly higher than that in the control group.

This study aims to evaluate the impacts of a community-based advance care planning programme on end-of-life care of patients with advanced disease. A mixed-method approach, including a randomized controlled trial and qualitative interviews, will be used. Participants in the experimental group will received a structured advance care planning programme delivered by a trained facilitator. It includes an educational component, reflection and a family meeting.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above
* meet one of the three triggers for supportive /palliative care as suggested in the Gold Standards Framework
* living at home
* being communicable

Exclusion Criteria:

* mentally incompetent
* cannot nominate a family carer
* have already signed an advance directive
* have been referred to palliative care service
Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue

In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the programming of obesity in early stages of life. This can be achieved by studying pregnant women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how these conditions could impact on fetal growth and development; the risk of obesity in the offspring during the first 3 years of life will be also assessed (genetic polymorphisms of the most recognized genes related to obesity; gene expression of placental biomarkers indicators of early programming, polyunsaturated fatty acids, immunological and pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies \& neurodevelopmental assessment...). Moreover, the interaction of pathological maternal conditions with confounder factors that could have a role in the proposed outcomes will be also studied (maternal and child dietary intake, medical history and socioeconomic \& environmental factors).


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women aged between 18 and 42
* singleton pregnancies
* pregnancy stage at recruitment: 12 weeks of pregnancy

Exclusion Criteria:

* Women who wish to participate in the study should not simultaneously participate in other research studies.
* Must be completely enclosed in one of the study of the groups without any possibility to be simultaneously incorporated on more groups of the study
* Mothers which are receiving any drug treatment, folate more than the 3rd first months, or DHA +/- vitamin supplements during pregnancy.
* Mothers affected by any disease other than those referred to the inclusion criteria, such hypertension or pre-eclampsia, foetal IUGR, mother infection during pregnancy, hypothyroidism / hyperthyroidism, hepatic diseases, renal disease,...
* Mothers following an extravagant diet or vegan diet.
Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project

Low back pain is one of the most common health problems seen in the primary care. Chronic low back pain is localized between the inferior limit of the ribs and the sacral region, and persist more than 12 weeks. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). No previous study has included a multimodal supervised program in patients with NSCLBP. The primary aim of this study is to determine the effectiveness of exercise + behaviour change + education + mindfulness programs (intervention 1) and an intervention including intervention 1 following functional resistance training (Intervention 2) on endogenous pain modulation, disability, muscle strength/endurance, quality of life, gait parameters, levels of physical activity, sedentary behaviour and psychological health in patients with NSCLBP.


Eligibility Criteria:
Inclusion Criteria:

* Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al1.
* Intend to participate in the intervention and perform all the tests included in the study.
* Able to read and understand informed consent, as well as the objective of the study.
* Able to walk and move without outside help.
* Able to communicate without problems.

Exclusion Criteria:

* Be under 20 years or over 65 years old.
* Having acute or terminal illness.
* Having medical prescription that prevents the performance of the tests.
* Having injury or circumstance that makes it impossible to perform the tests correctly.
* Having other physical or mental illness that prevents participating in the intervention.
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1

Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion.

The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants diagnosed with Myotonic Dystrophy, Type 1 (DM1).

The secondary purpose is to evaluate the potential of ERX-963 treatment to reduce excessive daytime sleepiness / hypersomnia and improve cognitive function in DM1 participants compared to placebo treatment.

This study is evaluating single administration of two dose levels of ERX-963 to explore the relationship between dose, safety, tolerability, exposure and clinical benefit. This is a multi-center, randomized, double-blind, placebo-controlled, two-treatment period crossover study in two cohorts of participants with DM1.

Participants who have consented and meet eligibility criteria will receive two treatments, placebo and ERX-963, in a randomized crossover fashion with a washout period between the treatments. On treatment days, participants will receive treatment followed by repeated blood collection for pharmacokinetic analysis and administration of a battery of outcome measures relevant to sleep and cognition.

Eligibility Criteria:
Key Inclusion Criteria:

* 18 to 65 years of age
* DM1 defined by genetic testing or clinical-confirmation
* Epworth Sleepiness Scale (ESS) of \> 11 or participants who have long sleep periods of an average of \> 10 hours a day
* Age of onset of DM1 greater than 16 years

Key Exclusion Criteria:

* Significant respiratory compromise
* Significant cardiac disease
* Diagnosis of symptomatic Restless Leg Syndrome or significant untreated nocturnal hypoxias
* Significant moderate to severe hepatic insufficiency
* Clinically active depression, anxiety, or other medical condition that, in the investigator's opinion, would interfere with the safety and efficacy assessments
* History of seizures
* History of panic disorders
(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?

Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results.

To help understand why sweat chloride was unresponsive, the investigators will use a newly developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil.

The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days) will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.

Cystic fibrosis (CF) is a genetic disease caused by malfunctioning of a protein called CFTR.

CF affects various organs including the sweat glands and the lungs. An FDA approved drug called ivacaftor helps some people with CF, and laboratory tests show that it produces further improvement when combined with an investigational drug called lumacaftor. However, results from clinical tests of the two drugs used together gave mixed results: lung function improved but sweat gland function did not improve. This study will measure CFTR-dependent sweat rate to test the hypothesis that CFTR in the normal sweat glands might be functioning at peak efficiency, and so can't be improved further with ivacaftor, thus accounting for the apparent discrepancy between lung function and sweat gland results. CFTR-dependent sweat rate is important to understanding CF because it is a very accurate measure of CFTR function.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults without a Cystic Fibrosis (CF) mutation
* Carriers with a known CF mutation

Exclusion Criteria:

1. Documented liver disease
2. Participants should not be taking:

   * medicines that are strong CYP3A (Cytochrome P450, family 3, subfamily A) inducers, such as:

     * the antibiotics rifampin and rifabutin;
     * seizure medications (phenobarbital, carbamazepine, or phenytoin); and
     * the herbal supplement St. John's Wort, substantially decreases exposure of ivacaftor and may diminish effectiveness.