cyrilzakka/clinical-trials huggingface dataset:
Study of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A

To evaluate the safety and efficacy of ORGN001(formerly ALXN1101) in neonate patients with MoCD Type A


Eligibility Criteria:
Patients must meet all of the following inclusion criteria to be considered for enrollment in this study:

1. Male or female neonatal patient (1 to 28 days of age \[inclusive\] at the time of ORGN001 administration, with day 1 of age corresponding to the day of birth) or infant (29 days to \<2 years of age) or child (2 to 5 years of age \[inclusive\]) with MoCD Type A, previously untreated with ORGN001 or treated with ORGN001 through Compassionate Use/Individual Named Patient access
2. In neonates, diagnosis of MoCD Type A, based on:

   Prenatal genetic diagnosis, or Onset of clinical and/or laboratory signs and symptoms consistent with MoCD Type A (eg, seizures, exaggerated startle response, high-pitched cry, axial hypotonia, limb hypertonia, feeding difficulties, elevated urinary sulfite and/or SSC, elevated xanthine in urine or blood, or low or absent uric acid in the urine or blood) within the first 28 days after birth
3. In infants or children, diagnosis of MoCD Type A, based on:

   Confirmed genetic diagnosis (genetic confirmation of the diagnosis of MoCD Type A may be obtained after initiation of ORGN001 therapy in certain cases), biochemical profile, and clinical presentation consistent with MoCD Type A
4. Parent or legal guardian must have signed the informed consent form (ICF) prior to any study procedures being performed

Patients will be excluded from participating in the study if they meet any of the following criteria:

1. Diagnosis other than MoCD Type A (may be determined after the initiation of study drug)
2. Condition that is considered by the treating physician to be a contraindication to therapy, including evidence of abnormalities on brain imaging not attributable to MoCD Type A, or that might otherwise interfere with the patient's participation in the study, pose any additional risk for the patient, or confound patient assessments
3. Antenatal and/or postnatal brain imaging prior to initiation of treatment with ORGN001 that indicates cortical or subcortical cystic encephalomalacia, clinically significant intracranial hemorrhage, or other abnormalities on brain imaging determined by the treating physician to be clinically significant
4. Modified Glasgow Coma Scale (mGCS) for Infants and Children score of less than 7 for more than 24 hours (does not apply to children less than 1 day in age).
Critical Incident During Anaesthesia

A multicenter study in Ukrainian hospitals on compliance with the requirements for responding to critical cases in the operating room, and the availability of relevant documentation and checklists.

Timely information and response to emergencies are important both in the context of patient safety and in the context of the hospital economy. The availability of information systems is one of the security requirements of the Helsinki Declaration of Patient Safety.

Ukraine has only just begun its path to implementing the Declaration of Helsinki in Ukrainian hospitals. The level of adherence to the recommendations can vary considerably depending on the region, the provision of the hospital and the effectiveness of the institution's internal management. In our survey of Ukrainian hospitals, only 74% of hospitals kept records of anaesthesia complications in general, with only 46% having separate electronic or paper documents to record complications; Also, the majority of respondent physicians (62.9%) reported the absence of checklists or algorithms for actions in case of emergencies or emergencies during anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* critical incident during anaesthesia: massive hemorrhage \>1000ml, difficult intubation, severe hypotension, severe bradycardia, desaturation, cardiac arrest, high spinal block, anesthetic toxicity, miocardial ischemia, severe arhytmia etc

Exclusion Criteria:

* critical incidents without aneasthesia
A Clinical Study of ONO-1110 in Patients With Hunner Type Interstitial Cystitis

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis


Eligibility Criteria:
Inclusion Criteria:

* Japanese (both sexes)
* Age (at the time of informed consent): 18 years and older
* Outpatient
* Patients who are considered capable of understanding the study procedures and completing the pain diary, bladder diary, and questionnaires appropriately by the investigator (sub-investigator）
* Patients given a diagnosis of HIC by cystoscopy
* Patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria

Exclusion Criteria:

* Patients with a history and presence of chemical cystitis
* Patients with a history of bladder augmentation or radical cystectomy
* Patients with pain other than HIC that may affect assessments in this study
* Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
* Patients receiving medications for psychiatric disease
Tapering Off Antidepressants

The purpose of this study is to compare two ways to stop taking an antidepressant medication and determine whether a faster or slower taper is better tolerated.

As abrupt cessation of antidepressant medication can cause distressing symptoms (including and not limited to worsened mood, irritability/agitation, anxiety, dizziness, confusion, and headache), the aim of this study is to compare the tolerance of two tapering regimens with the hypothesis that tapering the antidepressant dose over the course of two weeks will yield less discontinuation symptoms than a one week taper regimen. Additionally, it is suspected that discontinuing medications that inhibit the serotonin transporter , such as selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitors (SNRI) will have a greater difference in the frequency of discontinuation symptoms between the two and one-week tapering regimens versus antidepressants that don't inhibit serotonin transporter.

Demographic and clinical features will also be identified that may predict discontinuation symptoms with the hypothesis that patients on SSRIs and SNRIs may experience more discontinuation symptoms versus patients on non-SSRI/SNRI medications. Whether or not the treatment duration is positively associated with the number of discontinuation symptoms will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* Currently taking an FDA-approved antidepressant for at least four weeks on the list of approved medications: SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone or vortioxetine), SNRIs (desvenlafaxine, duloxetine, levomilnacipran, venlafaxine) and other classes (amitriptyline, bupropion, desipramine, doxepin, mirtazapine, nefazodone, nortriptyline, phenelzine, selegiline, or tranylcypromine). Clomipramine, a tricyclic antidepressant approved for the treatment of OCD, will also be included, but will be classed as an SSRI for this study because inhibition of the serotonin transporter is its primary therapeutic mechanism.
* No longer wish to take the antidepressant medication they are currently prescribed, due to one of the following reasons: 1) ineffective for symptoms; 2) intolerable side effect; 3) improvement of their illness for sufficient duration that it is clinically appropriate to consider tapering the medication.
* Primary psychiatric diagnosis of major depressive disorder, an anxiety disorder, OCD, or PTSD.
* Ability to read and understand English language.

Exclusion Criteria:

* Has met criteria at any time during their life for a primary psychotic disorder (e.g. schizophrenia), or dementia.
* Meets criteria for DSM-5-defined substance use disorder within three months of the screening visit.
* Currently taking two or more antidepressants.
* Presents with a clinically significant suicide risk, as assessed by a study physician.
* Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
* Women who are currently pregnant or lactating, or plan to become pregnant during the study.
A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis

In this study we will compare two electronic goniometric gloves to see if they can be used in research on joint movement in arthritis.

One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other is a glove that we have specially designed and developed for use in people with arthritis. Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints.

We aim to find out if the gloves are accurate and if they can be worn and used without too much discomfort by people with arthritis.

This is an open pilot study to assess the usability and accuracy of two electronic goniometric gloves in measuring finger joint movement in patients with Rheumatoid Arthritis.

We will use questionnaires to assess pain, stiffness and disability. We will be using an inner disposable glove worn under the electronic goniometric gloves as this will be important for infection control in clinical use.

We will calibrate the electronic goniometric gloves using wooden blocks at predefined angles using our own software calibration process to optimise the accuracy of the glove for the individual patient.

The patient will flex and extend their fingers repeatedly to get measurements of the minimum and maximum angle of flexion in their joints. During these movements we will also capture the dynamic characteristics of movement such as maximum velocity. In this study a laptop will be used to capture and record all of the measurements from the electronic goniometric glove and record the time at which the measurements were taken.

Each electronic goniometric glove will be refitted for a second set of tests to assess variability due to the fitting process. We will record a full set of data from each set of movements for later analysis.

Finally, we will assess usability and establish if patients have a preference between the two electronic goniometric gloves.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 to 80
* Diagnosis of Rheumatoid arthritis
* Patients who have significant pain and stiffness in their hands
* Correct hand size to achieve a good fit to the electronic goniometric glove

Exclusion Criteria:

* Poor fit for the disposable surgical glove
* Severe pain in the right hand
* Severe swelling in the right hand (rated as such by the investigator)
* Major permanent deformities in the right hand
* Active hyperextension \>30 degrees in any joint of the right hand
* Broken or infected skin in the right hand
* Known to have tested positive for Methicillin resistant staphylococcus aureus (MRSA) skin infections in the past
* Unable to don the lining disposable glove without significant discomfort
* History of Latex allergy
QoL Between CIEDs With and Without Rate Adaptive Pacing

Clinical implantable electronic devices, such as permanent pacemaker, implantable cardioverter defibrillator and cardiac resynchronization therapy are used in current daily practice for patients with bradycardia, ventricular arrhythmia, or heart failure. The rapid progress of permanent pacemaker function is growing to replace human's degenerating electrophysiology of heart.

The ability of physical work is an important cornerstone of quality of life. In daily activities, rate response to higher rate is importance for patients with bradycardia who can not accelerate their heart rate. And rate-adapting pacing of permanent pacemaker is a design to increase heart rate pacing according to physical activity or emotional activity. Patients with rate-adaptive pacing will get more cardiac output and overcome the physical activity such as stair climbing. But there are few studies to evaluate whether the rate-adaptive pacing of permanent pacemaker will improve the quality of life in people with bradycardia. The aim of this study is to compare turn-on with turn-off this function (DDDR vs DDD) whether rate-adaptive pacing will improve quality of life in patients with permanent pacemakers.


Eligibility Criteria:
Inclusion Criteria:

* sick sinus syndrome for permanent dual-chamber pacing
* pacemakers are implanted for ≥30 days with no complications.

Exclusion Criteria:

* (1) patient or legal representative could not provide written informed consent
* (2) unwillingness or inability to return for follow-up visits or reason to believe that adherence to follow-up visits wound be irregular,
* (3) current or scheduled enrollment in other, conflicting studies,
* (4) concomitant disease or other medical condition likely to result in death within 6 months, and
Clinical Massage Therapy as a Treatment for Carpal Tunnel Syndrome

Once participants have been recruited, their grip strength shall be tested and they will all complete baseline questionnaires to assess functional status and symptom severity.

Following the recruitment stage, participants will be asked to attend Medway Maritime Hospital once a week for four weeks, to receive the massage protocol. At the first session participants shall be asked to rate their pain (NPRS), before receiving a massage treatment. This will be followed by instructions on how to perform self-massage, which they will be asked to complete daily over the four-week period, and record in a diary. At the remaining three sessions, participants shall just complete the NPRS prior to receiving the massage treatment.

After four weeks the group will be reassessed at the same Orthopaedic Clinic they attended prior to recruitment. They will be asked to complete a final pain score, record any changes in their condition, repeat the initial symptom questionnaire, and finally preform a grip strength test. The duration of four weeks was chosen as this is the time-frame within which the specific massage protocol advises a 'significant symptom improvement' should be seen.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above.
* Pain paraesthesia and/or hypoesthesia in the hand, in the area innervated by the median nerve.
* Participants must have a clinical diagnosis of Carpal Tunnel Syndrome (CTS).
* Participant must be able to comply with the study procedures.
* Participant must have attended the Medway Maritime Hospital (Kent), for assessment of the present condition.
* Participant is willing and able to give informed consent for participation in the study.
* Participant must not be contra-indicated for the receipt of massage.
* Participants must be able to speak and read English fluently.

Exclusion Criteria:

* Participants who are receiving any additional treatment for their carpal tunnel pain that is not part of standard care (topical pain relief, bracing).
* Participants that have had any surgery on the anatomical sites relevant to the condition and/or treatment (neck, shoulder, arm, wrist, hand).
* Participants that have any suggestion of an additional condition related to carpal tunnel pain (i.e. previous trauma, pregnancy, etc).
* Planning to undertake any activities or lifestyle changes which may affect their levels of carpal tunnel pain (e.g. changing/ceasing occupation, alternative symptom therapy, adopting/ceasing a hobby).
Patient's Perception of Complications in Implantology.

To assess the influence that the complications of implant treatment have on the patient's perception and satisfaction on treatment.

The study is carried out in 5 dental centers with similar socio-professional characteristics.

The perception of patients with complications in implantology will be evaluated using a questionnaire.

All patients who present some type of complication in a dental treatment with implants will be included. Patients will be included both if they are aware of the complication, that is, they come to the consultation for it, and patients who are diagnosed with a complication in a routine check-up.

Patients will be informed of the complication and before explaining the treatment possibilities, their inclusion in the study will be formalized by signing the Informed Consent document.

Subsequently, they must fill out a questionnaire consisting of 5 questions about their perception of the complication and its influence on their quality of life.

The researcher will record the technical data of the implant treatment as well as the patient's responses in the Data Table.

After collecting a sufficient number of data, around 400 patients, the collaborating researchers will send their corresponding data tables to the main researcher who will be in charge of the statistical analysis together with obtaining the results.

Eligibility Criteria:
Inclusion Criteria:

Patients form 18 to 95 years old. Patients with dental implants supporting one o more implant prosthesis. Patients presenting one treatment complication affecting either dental implant or implant prothesis.

Exclusion Criteria:

Patients who does not accept informed consent and do not want to fill the questionnaire.

Patients with cognitive impairment. Patients under psychiatric treatment.
Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice


Eligibility Criteria:
Inclusion Criteria:

* All patients who are initiating treatment with Yervoy

Exclusion Criteria:

* Not Applicable

Other protocol defined inclusion/exclusion criteria could apply
Evaluation of the Efficacy of Ambu® aScope for Intubation in Cancer Tongue

This study compares the ascope with standard fiberscope using the nasal route of intubation in patient having sever difficult airway (having posterior one third cancer tongue with fixed mobility)

patient will be allocated into two group according to the type of endoscope used group (F) fibro scope group and group (A) the ambu ascope group The timer will be started (T0), when touching the fiberscope or a scope. The standard fiberscope or a scope2 will be introduced through the nostril and advanced through the vocal cords, once carina identified the time will be recorded ( T1) When correct positioning of the trachea confirmed by detection of the end-tidal co2 curve on capnography (T2).

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients of ASA physical status I and II who will be scheduled for posterior third fixed cancer tongue with severe difficult airway requiring naso-tracheal intubation
2. aged 18-70 years

Exclusion Criteria:

1. ASA 2 or 4
2. pregnant
Infective Endocarditis in the Elderly

ELDERL-IE is a multicenter national prospective observational study.

The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE).

The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

Population monitoring:

Clinical, therapeutic, biological, microbiological, echocardiographic and geriatric data are collected. (M-2/3 before inclusion; D-15 before inclusion; D0; M3; vital status at 1 year)

Eligibility Criteria:
Inclusion Criteria :

* all patients older than 75 years are eligible if they are considered and treated as a case of IE by physicians ensuring their medical care.
* the patient should be treated in one of the clinical sites participating at the study.
* the patient should benefit during initial hospitalization of a geriatric assessment, in addition to the usual clinical and therapeutic management of such patients.

Exclusion criteria :

* patients not fulfilling the criteria of definite or possible endocarditis according to Duke modified by Li diagnostic classification that will be applied after collection of all the data at the discharge of the patient.
The TracTOR (Tracking and Tracing Operations Research) Study -- Zimbabwe

This study evaluates the effectiveness of an enhanced package of support for activities described in the "Standard Operating Procedures (SOP) for Patient Tracing in Health Facilities in Zimbabwe". This package is intended to increase the effectiveness of active patient tracing activities by developing tools, providing mentorship and implementing systematic review of processes to improve communication, coordination, and supervision between community health workers and facility-based staff.

This study consists of a pre-/post- intervention rapid assessment of SOP implementation in study health facilities. The rapid assessment includes a facility audit, and the cross-verification of Mother-baby pair service records, and scheduled appointments. Following the baseline rapid assessment, the research team implements the proposed intervention package in health facilities randomly assigned to the intervention arm of the study. Data collectors conduct monthly visits to study facilities in order to extract appointment attendance information from PMTCT, ART, pharmacy, HIV exposed infants (HEI), and early infant diagnoses (EID) service registers.

Eligibility Criteria:
Inclusion Criteria:

Mother-baby pair (MBP):

1. Mother is HIV-positive
2. Infant was born between October 1st, 2013 and March 30th, 2015, or initiates HIV exposed infant services within the first seven months of the data collection period
3. Mothers and infants are assigned unique facility-issued ID numbers that can be used to pair their records, and link service attendance between clinical units, and over time
4. Enrolled in post-natal PMTCT, ART, or EID services at a study health facility
5. Based on guidelines in the SOP, MBP cannot be classified as lost to follow-up at beginning of data collection period

Community Health Workers (CHW):

1. CHW or facility-based staff working at selected study sites
2. Participated in the implementation of MBP tracking and tracing activities for a minimum of three months
3. Participant in district-level or selected facility-level CHW meetings
4. Above age of consent (18 years or above)
5. Able and willing to provide informed consent to participate in the study

Exclusion Criteria:

* If inclusion criteria not met