cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
* Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
* Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
* At least a 1-year history of migraine with or without aura consistent with a diagnosis
* Age of the participant at the time of migraine onset \< 50 years
* History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

* Difficulty distinguishing migraine headaches from tension-type or other headaches
* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
* Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
* ≥ 15 headache days per month on average across the 3 months prior to Visit 1
* Usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
* Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test
* Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
* Hypertension as defined by sitting systolic blood pressure (BP) \> 160 millimeter of mercury (mm Hg) or sitting diastolic BP \> 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
* At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
* History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.
Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer

1. To explore tissue-based biomarkers to select patients who do not respond to neoadjuvant immunotherapy (non-responders) at the point of diagnosis
2. To explore blood-based non-invasive biomarkers to predict pathological complete response (pCR) before surgery

1. Construction of a neoadjuvant chemoimmuntherapy cohort of resectable stage 2-3 lung cancer patients and acquisition of clinical-pathological-radiological data.
2. Plasma from individual patient will be collected at preneoadjuvant and postneoadjuvant stages and ctDNA analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven clinical stage II-III lung cancer patients
* No driver mutations (EGFR mutation and ALK alteration)
* Whole body performance (ECOG) 0-1
* Those over 19 years of age
* Subject who submitted Informed consent form

Exclusion Criteria:

* Under 19 years of age
* If there is a history of causing infection or other serious medical problems that impair the patient's function and make it difficult to comply with the study protocol.
* Patients for whom the investigator determines that the patient should not participate in the clinical trial because the patient is judged to be unable to comply with the clinical trial procedures and requirements (a person lacking medical capacity)
* Other patients (pregnant women, etc.) determined by the clinical trial director to be unsuitable for this clinical trial.
Maternal Variables Associated With Adherence in Children With Asthma

A questionnaire will be used in order to find out the reasons for poor adherence for long-term treatment in children with asthma. The hypotheses is maternal factors including the knowledge that asthma is a chronic disease and fear to administer inhaled steroids are major obstacles for appropriate adherence.

Parents to children aged 2 - 12 years with moderate to severe asthma who need long-term treatment with inhaled steroids will be included in the study. Three weeks after their visit in the clinic, they will be requested to answer a questionnaire by telephone.

Eligibility Criteria:
Inclusion Criteria:

* Parents to children aged 2 - 12 years with moderate to severe asthma to whom inhaled steroids was described for a period of at least 4 weeks.

Exclusion Criteria:

* Parents who will not agree to sign the consent form and parents who do not speak and understand the Hebrew language.
Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized Scleroderma

The study aims at evaluating the efficacy of the fractional carbon dioxide laser as a new modality for treatment of localized scleroderma and to compare its results with the well established method of UVA 1 phototherapy.

The study includes 20 Cases presenting with one or more lesions of morphea (plaque, linear and atrophic). Each case will be subjected to:

1. -Informed consent. 2-Detailed history 3- Clinical examination to assess type, site, extent. 4-Clinical evaluation before treatment, in the follow up period and after treatment ( 24 sessions of UVA1) (one month after last CO2 laser session) using a scoring system:

   * Skin thickness: 0-3, 0: normal; 1: thickened skin; 2: decreased ability to move the skin; 3: unable to pinch or move skin (according to the Modified Rodnan skin score)
   * Dermal atrophy: 0-3, 0: none, 1: shiny, 2: visible vessels, 3: obvious atrophy
   * Dyspigmentation (Hypo or hyper pigmentation): 0-3, 0: none, 1: mild, 2: moderate ,3: marked C- Digital Photography before, follow up and after treatment using the same digital camera , at fixed distance and constant settings for standardization .

     5-Investigations: A- Punch biopsy: A punch biopsy will be taken before and after treatment to be stained with haematoxylin and eosin.

B-Immunohistochemical assessment of

* MMP1 (matrix metalloproteinase 1) in the pre and post treatment skin biopsies.
* TGFß ( transforming growth factor beta)in the pre and post treatment skin biopsies.

  6-Treatment intervention: Two lesions with identical scoring will be chosen for the treatment interventions.
  1. Lesion number (1) will be subjected to: localized UVA1 phototherapy (340-400 nm), low dose irradiation, at a rate of 3 sessions per week , total of 24 sessions with full clinical evaluation and investigations before and after treatment and clinical follow up one month after treatment.
  2. Lesion number (2) will be subjected to: Fractional carbon dioxide laser (10,600 nm), a session once per month, total of 3 sessions with full clinical evaluation and investigations before and one month after the last session of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Types of morphea: plaque, linear and atrophic.
2. Patients are either new or discontinued systemic treatment for at least two months

Exclusion Criteria:

1. Morphea profunda and systemic scleroderma (diagnosed by: Rayaund's Phenomenon and sclerodactyly +/- internal organ affection)
2. Contraindications to phototherapy: eg: photosensitivity, systemic lupus, melanoma, skin cancer, or porphyria.
3. Contraindications to laser: Use of systemic retinoids in the last 6 months.
Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients

The study involves assessment of hearing and visual complications along with headache after accidental dural puncture in patients receiving epidurals. Hearing loss will be assessed by clinical examination and audiometry testing, while visual complications will be assessed by clinical examination. The patients will receive standard treatment for headache in the form of drugs and if required an epidural blood patch ( injecting patient's blood in the epidural space). The course of these complications and response to treatment will be investigated over a period of time.

Audiometry results from patients with dural puncture will be compared to those of patients who also had epidurals, but without a dural puncture.

The investigators hypothesize that audiovisual complications occur more frequently in patients having accidental dural puncture with epidural needle and that the symptoms resolve with the administration of epidural blood patch.

Although many studies have reported auditory complications after spinal, none have been done in obstetric patients with accidental dural puncture with epidural needle. Long term follow up of these complications has been unknown. The incidence of both auditory and visual complications is likely to be high in patients getting accidental dural puncture with 17G Touhy epidural needle as compared to small gauge spinal needles. Several case reports have been reported with such temporary and permanent hearing and visual loss. A prospective study to understand these complications is required. The study will provide us with the true incidence of audiovisual complications of dural puncture with an epidural needle. Early intervention in cases of dural puncture may alleviate or halt symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Parturients having accidental dural puncture during epidural placement for labour analgesia.
* Patients who give written informed consent to participate in the study.
* Dural puncture with 17G Touhy needle with/out headache
* Postural headache after 24 hours of epidural
* Labouring women undergoing vaginal or Cesarean delivery
* For the control group, patients with no dural puncture during epidural placement

Exclusion criteria:

* Patients refusing to consent
* Dural puncture with spinal needle
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer
* Participant has radiologically and endoscopically evaluable disease.
* Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment

Exclusion Criteria:

* Participant has distant metastatic disease.
* Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer.
* Participant has any history of interstitial lung disease or pneumonitis
* Participant has experienced any of the following with prior immunotherapy: any irAE of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary.
* Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers.
* Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
* Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients.
* Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).
Longitudinal Study of Children With Concussions

For children and adolescents who have had a concussion resulting in prolonged symptoms (\>3 months), the investigators will:

1. Measure post-concussion symptoms, cognitive and emotional function during the 3 years post-injury.
2. Determine length of recovery and frequency of return to prior level of sports participation.
3. Determine the incidence of and risk factors for subsequent concussion during the 3 years post-injury.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 8-17 years old who present to one of the Lurie Sports Medicine clinics for care of a concussion.
2. English-speaking patients

Exclusion Criteria:

1. Patients outside of the 8-17 years old age range
2. Patients who show structural abnormalities on neuroimaging.
3. Non-English speaking patients
Effect Of Local Cold Applıcatıon On Paın and Vıtal Sıgns Durıng Port Catheter Needle Insertıon

In this study, the effect of cold application on the pain experienced during port catheter needle insertion and the change in the patient's vital signs will be evaluated. It is thought that with this application, patients will experience less pain during port catheter needle insertion. The change in the patient's vital signs and pain status will also be evaluated. The research will be conducted in the outpatient chemotherapy department of a Hospital.

The effects of lidocaine cream, cryotherapy (cold application to the skin), cutaneous stimulation therapy (pressure and massage) methods , virtual reality application and aromatherapy applied via inhalation on reducing pain were investigated in order to reduce the pain during port catheter needle insertion. In this study, the effect of cold application on the pain experienced during port catheter needle insertion and the change in the patient's vital signs will be evaluated. It is thought that with this application, patients will experience less pain during port catheter needle insertion. The change in the patient's vital signs according to the pain status will also be evaluated. The research will be conducted in the outpatient chemotherapy department of Necmettin Erbakan University Faculty of Medicine Hospital. The universe of the research will consist of all patients with port catheters in the outpatient chemotherapy department of Necmettin Erbakan University Faculty of Medicine Hospital. The sample of the research will consist of patients who meet the inclusion criteria and agree to participate in the research.

Eligibility Criteria:
Inclusion Criteria:

Patients between the ages of 18-65, who are pain-free, receiving treatment in an outpatient chemotherapy unit, who have a port catheter, who have a Huber port needle of L (large) 20 mm-20 gauge, and who can read and write in Turkish.

Exclusion Criteria:

Patients taking "oxaliplatin" Patients aged 65 and over Patients who have started using a port catheter but whose stitches have not yet healed Patients who have not passed 30 days since the port catheter was inserted Patients with any redness, swelling or tenderness in the port catheter area
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older.
* Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems.
* Hepatic dysfunction \[Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin \> 3 times upper limit of normal range values\].
* Severe renal dysfunction (creatinine clearance \< 30 ml/min).
* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (NO-BACT)

Patients with negative blood cultures represent 85-90 % from all patients with a blood culture taken during hospital admissions. This population usually includes an heterogeneous group of patients that are admitted because of an infectious diseases or febrile syndrome in which performing a blood culture is required. There is scarce evidence about the clinical characteristics and the antibiotic treatment given to these patients. This project will be developped in two phases with an specific target in each one:

* Phase I (a cohort study of patient with blood cultured taken): the investigators aim to analyse the clinical and therapeutics characteristics, outcomes and antimicrobial stewardship oppotunities in a population of patients with negative blood culture. The investigators aim to compare the outcomes and antimicrobial stewardship opportunities with those in patients with positive blood culture.
* Phase II: The investigators will develop a cluster randomised control trial to evaluate the implementation of a targeted antimicrobial stewardship intervention in patients with negative blood culture (based on 3rd and 5th day audits). The effect of the intervention on the quality of antimicrobial use (duration and de-escalation), long of stay and mortality will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Health professionals in charge of patients with negative hemoculture and active antibiotherapy within 48 hours of extraction; and that belong to a clinical unit that has been assigned to the intervention arm.

Exclusion Criteria:

* Health professionals in charge of patients who, even if they meet the criteria described above, will not be considered to have a foreseeable death within \<72hrs from the hemoculture extraction or a positive hemoculture in the seven days prior to the extraction of the negative hemoculture.
Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age

The WIL-33 study aims to determine the efficacy, pharmacokinetics, immunogenicity and safety of wilate as routine prophylaxis in up to 12 paediatric patients (eight evaluable) with severe von Willebrand Disease VWD (defined as screening von Willebrand factor ristocetin cofactor activity \[VWF:RCo\] \<20%) under the age of 6 years, over a period of 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged \<6 years at the time of screening
2. Type 3 (at least four patients), severe type 2 (except 2N) or severe type 1 VWD (any of which with VWF:RCo \<20%) according to medical history, requiring substitution therapy with a VWF-containing product
3. Minimum body weight 12.5 kg at the time of screening
4. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted (obtained from the patient's parent(s)/ legal guardian(s))

Exclusion Criteria:

1. History or current suspicion of VWF or FVIII inhibitors
2. Injection of DDAVP or VWF-containing product within 72 hours prior to inclusion
3. Medical history of a thromboembolic event
4. Platelet count \<100,000/µL at screening (except for VWD type 2B)
5. Patients receiving, or scheduled to receive, immunosuppressant drugs (other than antiretroviral chemotherapy), such as prednisone (equivalent to \>10 mg/day), or similar drugs
6. Treatment with any investigational medicinal product (IMP) in another interventional clinical study currently or within four weeks before enrolment
7. Other coagulation disorders or bleeding disorders
8. Known hypersensitivity to any of the components of the study drug
Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors

Matrix-Rhythm-Therapy(MRT) has been included in neuro-rehabilitation program for stroke patients to regulate increased muscle tone.

There are no controlled studies with large sample size on the efficacy of MRT on spasticity. In this context,to the best of our knowledge, our study is the first study on this subject. The results of the study will develop a new perspective for management of spasticity and will ensure more common use of MRT.Further studies are needed on superiority of MRI over other treatment methods used in gait and balance rehabilitation of hemiparetic individuals. The aim of this study was to investigate the effectiveness of combining Bobath therapy (BT) and MRT on muscle tone,balance and gait parameters in stroke individuals with spastic hemiparesis.


Eligibility Criteria:
Inclusion Criteria:

* aged between
* to discharge from the hospital,
* to have single-sided hemiparesis for the first time,
* to have hemiparesis at least four weeks earlier.
* to have Modified Rankin Score of ≤3, Modified Ashworth Scale score between 1-5 for the lower extremity.

Exclusion Criteria:

* to use a cardiac pacemaker,
* to have aphasia, open wound in the area to be treated,
* to have circulatory problem, skin lesions, other neurological, psychiatric and/or orthopedic problems other than hemiparesis affecting gait.