cyrilzakka/clinical-trials huggingface dataset:
A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)

A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

This multicenter, double-blind, placebo-controlled, randomized (1:1) discontinuation study is a 4-part study designed to evaluate the efficacy and safety of multiple dose administration of amifampridine phosphate in patients with LEMS. Data from parts 2 and 3 (the double-blind parts of the study) are presented in this record.

Eligibility Criteria:
Inclusion Criteria: Individuals eligible to participate in this study must meet all of the following inclusion criteria:

* ≥18 years of age
* Confirmed diagnosis of LEMS
* Normal respiratory function
* Normal swallowing function
* If receiving peripherally acting cholinesterase inhibitors a stable dose is required for at least 7 days prior to Screening.
* If receiving oral immunosuppressants a stable dose is required for at least 90 days prior to Screening.
* Negative pregnancy test for females of childbearing potential
* If sexually active, willing to use 2 acceptable methods of contraception
* Willing to perform all study procedures as physically possible.
* Willing and able to provide written informed consent after the nature of the study has been explained and prior to the start of any research-related procedures.

Exclusion Criteria: Individuals who meet any of the following exclusion criteria are not eligible to participate in the study:

* History of epilepsy or seizure.
* Known active brain metastasis.
* Use of Fampridine (4-aminopyridine), and any form of 3,4-diaminopyridine other than the IP provided, such as amifampridine base or Firdapse, during the study.
* Use of medications known to lower the epileptic threshold within 7 days or 5 half-lives.
* Use of medications which inhibit neuromuscular junction function within 7 days or 5 half-lives.
* Use of IVIG, plasmapheresis (plasma exchange), or immunoadsorption within 90 days
* Use of guanidine hydrochloride within 7 days
* Use of rituximab within 12 months
* History of drug allergy to any pyridine-containing substances or any amifampridine phosphate excipient(s).
* Use of any other investigational productwithin 30 days
* Treatment with a concomitant medication that prolongs the QT/QTc interval within 7 days or 5 half-lives.
* Treatment with sultopride (4-amino-N-\[(1-ethylpyrrolidin-2-yl)methyl\]-5-ethylsulfonyl-2-methoxybenzamide) within 7 days.
* An abnormal electrocardiogram (ECG).
* Documented history of arrhythmias.
* History of additional risk factors for torsade de pointes.
* Breastfeeding or pregnant or planning to become pregnant (self or partner) at any time during the study.
* Likely or expected to require treatment for cancer within 3 months (90 days) after entering.
* History of severe renal impairment or evidence of severe renal impairment
* Any condition that places the patient at high risk of poor treatment compliance or of not completing the study.
* History of uncontrolled asthma.
Home Based Computer Gaming Hand Exercise Regimen for People With Arthritis Affecting the Hands

The purpose of the study is to determine whether a novel computer gaming hand exercise regimen would improve hand function, decrease pain/ stiffness and be feasible in people with Rheumatoid arthritis or Osteoarthritis affecting the hands.

A novel computer gaming hand exercise regimen has been designed for people with Rheumatoid arthritis (RA) or Osteo arthritis (OA) affecting the hands. The design allows a broad range of common objects of daily life to be seamlessly transformed into 'therapeutic' input devices by instrumenting with a small motion sense mouse. Based on individual abilities and treatment needs, objects are selected to train specific fine/ gross dexterous functions. The object manipulations (therapeutic exercises) are then used to control and play any commercially available computer game, making practice challenging and engaging.

The study is of six weeks duration comparing the computer gaming and conventional hand exercises in thirty people diagnosed with RA or OA affecting the hands. The investigators hypothesize that the game based exercises will improve hand function and reduce pain/stiffness and be feasible compared to the conventional hand exercises.A mixed-effect repeated measures analysis of variance will be conducted to test pre to post treatment outcomes. This will be the first study to evaluate the therapeutic effects and feasibility of the computer gaming hand exercise regimen in people with RA or OA.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged between 30-70 years
* Clinical diagnosis of Rheumatoid arthritis or Osteoarthritis of hands according to American college of rheumatology criteria
* Must own a home computer and have basic working knowledge of computers.
* Present with scores ranging from 0-75 on self-reported hand function ability with the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire

Exclusion Criteria:

* Severely deformed finger joints
* Neurological conditions of dominant side upper limb
* Trauma in wrist or hand
* Upper limb surgeries in previous six months
* Co-existing hand conditions in the dominant hand
* Problems with vision or hearing
* Recent changes in drug regimen (Disease modifying anti-rheumatic drugs (DMARDs) or corticosteroids \<3 months)
* Major diseases of heart or lungs or liver
* DASH scores 0-75.
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides


Eligibility Criteria:
Inclusion Criteria:

* Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory

Exclusion Criteria:

* No samples from outside Makerere's Domain
Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)

The purpose of this study is to determine the antioxidant effect of prolonged use of sorghum bicolor (jobelyn) to increase the level of plasma superoxide dismutase and glutathione reductase in patients with sickle cell disease and to determine if there is any improvement in the quality of life of the patients.

Jobelyn is an extract of sorghum bicolor that is popular in Nigeria as a herbal food supplement. This extract has been shown to have a high oxygen radical absorbance capacity (ORAC 37,622micro mole TE/g) compared to other botanical preparations 1. A second proven property is its anti inflammatory effect with a selective COX 2 inhibition 2. It has also been shown to correct anaemia induced in experimental rabbit by trypanosome brucei brucei 3.

Jobelyn is being consumed as a herbal nutritional supplement in many disorders including sickle cell disease in Nigeria without complaint in over 15 years. The toxicology profile is impressive with a wide therapeutic range.

Nigeria is one of the countries with the largest burden of sickle cell disease. It is a chronic genetic disorder that accounts for absenteeism at school and at work place. There is also a significant shortening of the life span of the affected patients. Sickle cell anaemia presents with recurrent bone pains and progressive organ damage that affects negatively the quality of life of the patients. Available measures that have been in use include use of hydroxyurea, chronic and acute red cell transfusion and haematopoietic stem cell transplantation. These have limitations in terms of adverse effects, cost and availability.

The pathogenesis involves intracellular precipitation of the mutant haemoglobin, rigidity of the cell, adhesion of cells to the endothelium. These cause recurrent tissue hypoxia and reperfusion which cause release of reactive oxygen series and agents of inflammation. The extract of sorghum is therefore expected to improve the quality of life of these patients.

Previous work done, have not investigated the long time effect of the extract on the quality of life of sickle cell patients. This study is therefore designed to compare the quality of life of patients on 500mg daily, 250mg daily and 2mg daily of jobelyn using adjusted standard tools. The secondary outcomes to study are changes in indicators of inflammation and systemic antioxidants in these patients. The study period is 12 months so that the period shall involve all the weather conditions in the region.

Eligibility Criteria:
Inclusion Criteria:

1. AGE : 14 To 40 years
2. SEX: Both sexes
3. Homozygous for the S gene (SS)

Exclusion Criteria:

1. Age below 14 years and above 40 years
2. Evidence of organ failure i.e heart failure, renal failure
3. No consent for study
4. Poor adherence to treatment and irregular visit to the clinic
5. Presence of chronic inflammation
6. Pregnancy
Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use

The purpose of this study is to evaluate the ability of Neuro-Stim System, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.

Pain is a complex problem that complicates recovery and rehabilitation after traumatic injury and surgery. The physician must balance pain management therapies against the potential for side effects and complications. Most of the treatment options for pain are pharmacological and have the potential for serious side effects and drug interactions. A non-pharmacological treatment would reduce the risk of adverse events and likely enhance the overall multimodal pain plan. The purpose of this study is to evaluate the effectiveness of Neuro-Stim System (NSS), a non-pharmacological option that uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system, to treat pain and improve sleep. Pain patients will be asked to participate in a study to evaluate the ability of Neuro-Stim System to reduce pain and to treat insomnia. NSS is a Federal Drug Administration (FDA) approved device intended to be used for chronic and acute pain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be inpatients (at Walter Reed National Military Medical Center) at the time of study enrollment and study device placement.
* Any patient experiencing post-operative pain (visceral, somatic, or neuropathic) and has a pain score (measured via DVPRS v2.0) equal to or greater than 4 for at least 3 hours in the past 24 hours.
* Has an intact external ear where device can be placed
* The skin of the ear at placement site must be free of infection
* The participant cannot have been on regularly scheduled central acting opioids for more than 30 days continuously leading up to the initiation of the study. However, intermittent, breakthrough opioids are permissible, but the potential subject must have a current opioid prescription.
* The participant must have vital signs (HR/breathing/blood pressure) within normal limits.
* Able to understand English and verbalize their pain level.

Exclusion Criteria:

* Have inconsistent vital signs (fluctuating, extremely low blood pressure, tachycardia, etc.)
* Wear any time of implanted electrical device such as a brain shunt, vagal stimulator, pace maker, spinal pain pump, etc.
* Pregnant (by results of preoperative Human Chorionic Gonadotropin or hCG urine or blood testing)
* Has a history of skin allergy to metals
* unwilling to voluntarily participate
* hemophilia
* Psoriasis vulgaris on ears
Impact of Positive End-expiratory Pressure on Hepatic Venous Flow

The purpose of this study is to determine the difference in the impact of moderate positive end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac surgery: conventional versus protective ventilation strategy The possible changes in forward and backward flows (Doppler profiles) of hepatic venous flow at different degrees of PEEP in conventional and protective ventilation strategies are analyzed by using intraoperative transesophageal echocardiography (TEE) in patients undergoing cardiac surgery .

Following data would be determined after 5 min-exposure volume controlled ventilation employing tidal volume of 10 ml/kg and 6 ml/kg with low PEEP (with 2 mmHg) and moderate PEEP (7 mmHg) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=12)

1. sum of forward hepatic venous flow
2. sum of backward hepatic venous flow
3. peak velocity of diastolic hepatic venous flow
4. lung compliance
5. peak airway pressure
6. mean airway pressure
7. other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery
* Patients provide written informed consents

Exclusion Criteria:

* Re-do or tri-do surgery
* Patients with active infection
* Patients with endocrine disease
* Patients ischemic heart disease
* patients with tricuspid valve regurgitation greater than mild degree
Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: Pilot Study of Multidimensional Effects

The goal of this clinical trial is to measure the effects of a speech therapy protocol combining anomia therapy and executive function training on naming and discourse in people with chronic aphasia, and to study the related brain changes.

The main questions it aims to answer are:

* Does the protocol improve naming skills ?
* Do the improvements observed transfer to discourse abilities ?
* Are there any brain changes induced by this protocol ?

Researchers will compare anomia therapy alone to anomia therapy + executive function training to see if the latter works better.

Participants will:

* Have a whole language assessment and a Magnetic Resonance Imaging (MRI) scan in the hospital before and after the protocol
* Receive 18 sessions of the protocol, 3 times a week during 6 weeks, in the hospital
* Have several naming assessments during the protocol


Eligibility Criteria:
Inclusion Criteria:

* Adult (18-80 years old) with post-stroke aphasia (\> 6 months post-stroke)
* Participant or legal representative able to understand the aims of the study
* Participant or legal representative who have signed an informed consent form

Exclusion Criteria:

* Aphasia with severe anarthria (mutism), comprehension disorders or alexia, incompatible with the purpose of the study
* Contraindications for MRI
* History of head trauma, brain tumor, neurodegenerative disease, or any other neurological or psychiatric condition
* Non-affiliation to social welfare
Treatment of Pelvic Ring Fractures in the Elderly

Pelvic ring fractures in the elderly are associated with high morbidity during standard conservative treatment due to immobility. Furthermore the risk of long term dependence even after the fracture has united is high. In analogy to the treatment of hip fractures in a similar patient population, patients might benefit from surgical treatment due to a reduction in pain and early mobilization.

Comparison of surgical vs conservative treatment with respect to mobility, pain, morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* CTI/MRI verified fracture of the sacrum affecting the posterior ring or both posterior and anterior ring
* age\>65 years, ambulatory with/without walking aids before Trauma
* ambulatory with/without walking aids before trauma
* postmenopausal status in women
* informed consent for study participation and surgery

Exclusion Criteria:

* Refusal of consent by the patient or legal representatives to participate in the study
* Other fractures or
* Unstable pelvic fracture (type B or C according to classification of 'Arbeitsgemeinschaft für Osteosynthesefragen' (AO)/OTA) requiring surgical stabilisation after high- or low-energy trauma
* Suspicion of a pathological fracture in the context of known or unknown malignancy
* Previous surgery of the pelvis with metal obstructing the planned paths of the ilio-sacral screws
* Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
* Comorbidity that precludes undergoing general or spinal anaesthesia
* Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient being in a wheel chair)
Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients

The current study focused on ultrasound guided brachial plexus block (BPB) which plays an important role in patients with hand trauma either in pain control or for surgical intervention. The brachial plexus can be blocked by several techniques but the most commonly used are the supraclavicular (SCB) and axillary (AXB) blocks. Aim of this study is to compare between the two techniques as regard performance time, needling time, anesthesia related time, block related complications, number of needle pass, and block related pain. 80 patients were allocated randomly into two equal groups, under ultrasound guidance the SCB and AXB were done for the two groups respectively. The needling time, performance time, anesthesia related time, onset time, number of 1st needle pass in each group and block related complications were noted.


Eligibility Criteria:
Inclusion Criteria:

* patients with ASA physical status II and III, and body mass index (BMI) between 20 and 35, aged 40-70, undergoing emergency crushed hand surgery

Exclusion Criteria:

* Patients with significant coagulopathy, infection or trauma at the injection site of local anesthetics, allergy to local anesthetics, refusal to participate, known neuropathies patients, mentally retarded patients, severely trauma patients who required general anesthesia from the start in the pre-induction room, and unconscious patients due to the accident. Also, shocked patients and patients with chronic obstructive airway disease
Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)

The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Either one of the following risk factors is sufficient for inclusion (high risk patient)
* Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), \>30 days prior to randomization)
* Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
* Symptomatic congestive heart failure
* Impaired left ventricular systolic function
* Diabetes mellitus; Hypertension requiring anti-hypertensive treatment
* In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy

Exclusion Criteria:

* Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
* Conditions associated with increased risk of major bleeding
Local Potential Measurement In PFA: A Pilot Study

This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure indicated by investigator for the treatment of atrial fibrillation.

Male or non-pregnant female aged ≥18 years.

Able and willing to provide written informed consent prior to any clinical investigation related procedure

Exclusion Criteria:

* Pregnant or nursing subjects.
* Current participation in another investigational drug or device study that interferes with this study.
* Subjects who, in the opinion of the investigator, are not candidates for this study.
* Patients who have had a prior ablation procedure
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
* Life expectancy is less than 12 months, in the opinion of the investigator
* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Facial Cosmetic Acupuncture on Skin Rejuvenation

Facial Cosmetic Acupuncture technique includes wrinkles, acupoints and muscle points on the face, head and neck. This study is designed to determine the efficacy and safety of Facial Cosmetic Acupuncture on skin rejuvenation.


Eligibility Criteria:
Inclusion Criteria:

* Patient age of 40 to 59 years
* Glogau photoaging scale III-IV

Exclusion Criteria:

* Who had undergone any dermabrasion, deep skin peels, laser resurfacing (ablative or non-ablative), botulinum toxin or filler injection, topical steroid within 6 months prior to study entry
* Patient with obvious skin disease
* Patient with a history of chronic skin disease
* Keloidal or hypertrophic scar tendency
* Pregnant or lactating patients
A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group

The digital health tool is an application ("app") available on iOS and Android enabled mobile phones. Health Care Providers ("HCPs") configure algorithms which can be tailored to individual patient's needs and then prescribe the app to support optimal basal insulin titration and dosing. In this study, participants will be recruited from a medical practice in which an HCP has prescribed a once-daily basal insulin. Participants will be trained on the use of the app utilizing their own mobile phone. During training, a brief self-assessment survey will be administered. After 90 days of usage, a telephone survey will be conducted. The baseline A1C results and the end of study A1C results will be collected from the patients' routine clinical care records. Data from the retrospective control group will be collected from a chart review of the same practice.


Eligibility Criteria:
Inclusion Criteria:

- Prospective cohort: The participants will be patients with type 2 diabetes mellitus who are not at goal on their current dose of prescribed basal insulin (e.g. Lantus, Toujeo, Levemir, Tresiba, or Basaglar). Participants shall be age 21 or older, prescribed basal insulin within the past 18 months, own a compatible mobile phone, able to receive/make calls and read messages on their phone. There is no predefined gender or ethnic group. Participants should be generally healthy and not expected to be hospitalized for surgery or other medical care during the study period.

- Retrospective cohort: This will be a chart review. Participants will be matched to the prospective cohort for age, gender and baseline A1C. Patients should have been prescribed one of the basal insulins above.

Exclusion Criteria:

- Prospective cohort: Participants with stage 4 or 5 kidney disease, active malignancies, variable glucocorticoid doses during the study period, severe visual impairment, or dementia will be excluded. Also, participants prescribed rapid-acting or premixed insulins (any insulin not on the above list) will be excluded.

- Retrospective cohort: Same as above.