cyrilzakka/clinical-trials huggingface dataset:
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)

The primary objective of this extension study was to further assess the safety and tolerability of talimogene laherparepvec. Secondary objectives were to assess objective tumor response rate and survival.

This was an extension study to the multicenter, open-label, phase 2 Study 002/03 (NCT00289016). Participants who had received the maximum 24 treatments under Study 002/03 and met the inclusion and exclusion criteria were eligible to enroll.

Participants continued to receive talimogene laherparepvec until discontinuation criteria were met. The discontinuation criteria were complete response, clinically significant progressive disease that rendered further dosing futile, receipt of 24 treatments or 12 months on treatment (whichever was longer), occurrence of an unacceptable toxicity, death, investigator determination that other treatment was warranted, or another criterion for withdrawal from treatment (participant request, noncompliance with study procedures, or sponsor request).

Eligibility Criteria:
Inclusion Criteria:

1. Previously participated in Study 002/03 and met 1 of the following:

   1. Received the maximum 24 treatment injections in Study 002/03 and had not yet achieved a complete response (CR) and whose response to OncoVEX\^GM-CSF indicated that treatment beyond 12 months was warranted, or
   2. Did achieve a CR in Study 002/03 and developed disease progression within 12 months of achieving a CR, or
   3. Terminated treatment in Study 002/03 to allow for treatment of brain metastases. Treatment for brain metastases was no longer ongoing and the patient was able to return to OncoVEX\^GM-CSF injections within 3 months of completing treatment for brain metastases.
2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.

Exclusion Criteria:

1. Prior Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 or 4 toxicity related to OncoVEX\^GM-CSF of any organ system (with the exception of injection site reactions, fever and vomiting);
2. History of Grade 3 fatigue lasting \> 1 week while on OncoVEX\^GM-CSF treatment;
3. History of Grade 3 arthralgia/myalgias while on OncoVEX\^GM-CSF treatment;
4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other OncoVEX\^GM-CSF-related non-hematological toxicities while on OncoVEX\^GM-CSF treatment that required a dose delay or discontinuation of OncoVEX\^GM-CSF therapy;
5. Symptomatic malignant disease progression that required alternative melanoma treatment;
6. Primary malignancy disease progression despite treatment with OncoVEX\^GM-CSF;
7. Patient requested to be withdrawn from or was unable to comply with the demands of Study 002/03.
8. Patient was withdrawn from Study 002/03 at the discretion of the Investigator.
Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.

Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.

Eligibility Criteria:
Patients must meet all inclusion criteria:

1. Between the ages of 18 and 90 years old
2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines.
3. Weight more than 30 kg
4. Full code

Exclusion Criteria:

1. Not diagnosed with severe sepsis or septic shock
2. Younger than 18 or older than 90 years old
3. With a history of nephrolithiasis
4. Who are pregnant
5. Weigh less than 30 kg
6. Not located in the ICU
7. Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort measures only (CMO)
8. Currently on dialysis
Effect of Hand Exercises on Hand Grip Strength and Manual Ability in Children With Visual Impairment

Development of the visual system immediately starts after birth via visual stimuli and interactions with the environment. The World Health Organization (WHO) has categorized visual impairments with respect to the best-corrected visual acuity as follows: blindness (Snellen visual acuity of 3/30), severe visual impairment (Snellen visual acuity between 6/60 and 3/30), moderate visual impairment (Snellen visual acuity between 6/18 and 6/60), and mild or no visual impairment (Snellen visual acuity of 6/18). The proper function of hands, particularly in delicate activities, depends on the interaction between the various regions of the brain, particularly, the sensory and motor cortex. Sensory stimulation can be used in such children to improve their manual dexterity and therapeutic interventions can be applied to gain hand strength. Developing skillful hands is a necessity in blind children as it often compensates for their missing vision. This study will focus on effectiveness of hand grip strength and manual ability with sensory stimulation in children with moderate to severe visual impairment.

Theraputty hand exercises and sensory stimulation techniques will be used.

Randomised control trial will be conducted with sample size 20. 20 participants will be included in the study. There will be 10 individuals who will receive hand exercises along with sensory stimulation to improve hand grip strength and manual ability and 10 Individuals who will only receive hand exercises to improve hand grip strength and manual ability. Grip strength and will be analyzed using hand dynamometer. For manual dexterity, box and block test will be used. Grip strength and manual dexterity will be analyzed before and after the intervention.Group A individuals will only receive hand exercises to improve hand grip strength and manual ability. Group B individuals will receive hand exercises along with sensory stimulation to improve hand grip strength and manual ability.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with moderate (Snellen visual acuity between 6/18 and 6/60) to severe (Snellen visual acuity between 6/60 and 3/30) congenital visual impairment. (9)
* Children diagnosed with bilateral congenital visual impairment. (9)
* No prior exposure to therapeutic interventions given to hands. (9)
* Children who can understand English or regional Urdu language. (9)
* Children aged above 6-12 years (9)
* Children of either gender will be included.

Exclusion Criteria:

* Children with any orthopedic problem related to hand. (9)
* Children who went through any surgery of hands or eyes. (9)
* Children with any neurological issues related to hand. (9)
* Those who were unable to communicate or unable to hear well .(5).
* Children diagnosed with complete blindness (Snellen visual acuity of 3/30) .(5).
* Non-co-operative patients
The Analysis of the Risks of the Personnel Working in Anesthesiology Departments in Turkey

The aim of the study was to investigate the analysis of the risks faced by the personnel working in the field of Anesthesiology and Reanimation in Turkey

There are many potential risks in operating room such as anesthetic gas exposure, chronic noise, fair, intensive working conditions, frequent guardians of the doctors and anesthesia staff. Those are effects the staff of anesthesia such as doctors, anesthesia assistants, anesthesia nurses. They usually suffer from hard working, fatigue and exposing anesthetic gases effects them as well. These reasons cause some undesirable adverse effects. The scientific dates are really limited in uour country. We aimed to ask questions the anesthesia staff and determine the environment conditions and the other risk in operating room that effects the staff. For t his purpose we prepared a questionaire and send to their e-mail address.

Eligibility Criteria:
Inclusion Criteria:

* anesthesia doctors anesthesia nurses anesthesia technic personal

Exclusion Criteria:

-
Prevention of Postprandial Hyperglycemia by Acarbose May be a Promising Therapeutic Strategy for Reducing the Increased Risk for Cardiovascular Disease

The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus
* Age \>/= 18 years
* Naive to acarbose (minimum 3 months before inclusion)

Exclusion Criteria:

* Hypersensitivity to acarbose or any of the excipients
* Age \<18 years
* Pregnancy and in nursing
* Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
* Chronic intestinal diseases associated with marked disorders of digestion or absorption
* States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach\] and larger hernias)
* Hepatic and severe renal impairment (creatinine clearance \<25 mL/min/ 1,73m2)
A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.

This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Participants are eligible to be included in the study only if all the following criteria are met:

  1. Male or female, age ≥18 years on the day of signing informed consent.
  2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
  3. Life expectancy ≥3 months, per the investigator's evaluation.
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  5. Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC.
  6. Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.

Exclusion Criteria:

* Participant must be excluded from participating in the study if the participant:

  1. Is pregnant or a nursing female.
  2. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
  3. Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention.
  4. Before the first dose of study intervention:

     * Had received prior systemic antineoplastic chemotherapy and targeted, biological therapy
     * Had prior treatment with any other anti-PD-1, PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against TIGIT, IDO, PD-L1, CTLA-4, and LAG3.
     * Has participated in any other BAT3306 study and has been treated with BAT3306.
     * Had major surgery \<3 weeks prior to first dose
     * Received radiation therapy to the lung that is \> 30 Gy within 6 months of the first dose of study intervention.
     * Completed palliative radiotherapy within 14 days of the first dose of study intervention.
  5. Is expected to require any other form of antineoplastic therapy while participating in the study. and so on
Physical Activity and Social-media Support

This study is a 3-arm randomized intervention to provide exercise education through Instagram. The primary outcome is trust in the content presented.

Social media is an interpersonal-level technology that can provide physical activity support through social support and behavioral education. One popular social media platform is Instagram. However, there is limited data on whether participants trust the content delivered through this platform. There is also limited information on whether the social-media account holder plays a role in the acceptance of the content. The purpose of the proposed study is to determine participants perceptions of physical activity related information and social media account. The design for this study is a 3-arm randomized intervention through Instagram. Participants (n=60) will be randomized to one of three Instagram accounts (control, student, and scientist). Recruitment will be on a rolling basis for 2 months; once participants are deemed eligible, they will be enrolled for 4-weeks and will receive a weekly questionnaire to determine their perceptions. Participants will also be encouraged to participate in follow-up questionnaires at 2 and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* less than 150 minutes of moderate-to-vigorous exercise per week
* active Instagram account

Exclusion Criteria:

* physical activity is inadvisable based on the PAR-Q+
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as a monotherapy for Major Depressive Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 65 years, inclusive.
* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
* Current major depressive episode.

Exclusion Criteria:

* Any current and primary psychiatric disorder other than Major Depressive Disorder.
* Severe alcohol or substance use disorder.
* History of bipolar I and II disorder, psychosis, and/or mania.
* Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
* Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
Improvement of Support to Caregivers of Cancer Patients in Basic Palliative Care at Home

The aim of the project is to evaluate the use of the caregiver-led 'CSNAT intervention' to identify, prioritize and address support needs among caregivers of cancer patients who are starting in basic palliative care at home in Denmark


Eligibility Criteria:
Inclusion Criteria:

* The patient should have advanced cancer
* The caregiver and patient should be able to read and understand Danish
* The caregiver and patient should give written informed consent
* The patient should be newly referred to basic palliative care (BPC) by home nurses in the municipality.

Exclusion Criteria:

* The caregiver is viewed by the practitioners as being too distressed to be asked about participation
* The caregiver has a known cognitive impairment precluding participation (based on the practitioners' clinical judgement)
Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate

This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).

This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study. In this ST-003 (OF-CALISTA) study, the occurrence of delayed adverse events, standard of care treatments for calciphylaxis (medications \[including Sodium Thiosulfate Injection and pain medication\], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) will be recorded during an 8-week observation period following patient participation in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).

Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled as a patient in ST-001 CALISTA study
* Willing to provide written informed consent
* Willing and able to adhere to all study-related procedures
* Willing to authorize release of medical records
* Willing to authorize collection of medical data from health care providers
* Provide email, home address and phone number where he/she can be reached

Exclusion Criteria:

• Patient did not participate in ST-001 CALISTA study
Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)

Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias.

The aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness.

Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses.

The investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.


Eligibility Criteria:
Inclusion Criteria:

* Subject from 18 years-old to 45 years-old
* Affiliated to social security
* Written informed consent

  \* CASE specific inclusion criteria :
* NREM parasomnia diagnosed according to the International Classification of Sleep Disorders 3rd edition (ICSD-3) criteria and confirmed by polysomnography assessment
* Frequent symptomatology (at least 1 episode by week in the past 3 months)

  \* CONTROL specific inclusion criteria :
* No medical history of NREM parasomnia

Exclusion Criteria:

* Known skin allergy to metal
* Use of psychotropic drugs during the 15 days before the inclusion
* Use of analgesic drugs during the 15 days before the inclusion
* A diagnosis of sleep apnea syndrome, periodic limb movements or restless legs syndrome present more than twice a week
* Medical history of epilepsy
* Non stable psychiatric disorder
* Pregnancy, breastfeeding
* Subject deprived of liberty or protected by law (tutorship, curatorship).
Association Between Tumor Size and Prognosis in Patients With Small Bowel adenocarcinoma-a SEER-based Study

The goal of this observational study is to learn about in small bowel adenocarcinoma patients. The main question it aims to answer is the association between tumor size and prognosis in patients with small bowel adenocarcinoma. Participants will be compared for the relationship between tumor size and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. pathology confirmed as SBA;
2. received surgery and complete postoperative follow-up data;
3. histology type code 8140-8380.

Exclusion Criteria:

Cases with unknown tumor location, size, TNM staging, race, and degree of differentiation were excluded. Finally, 8,163 eligible patients were included in the analysis
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients

This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).


Eligibility Criteria:
Inclusion Criteria-

* Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin
* Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin
* Patient is willing and able to provide consent

Exclusion Criteria-

* Female patient of childbearing potential
* Patient has a clinically significant concurrent medical illness
* Patient is judged by the treating physician to be inappropriate for the study.