cyrilzakka/clinical-trials huggingface dataset:
Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients

A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant.

Objectives: Chronic pain is associated with insomnia. The objective of this clinical study is to compare the efficacy and safety of different prescribed doses of Zopiclone and Clonidine; for the management of insomnia in patients with chronic pain.

Methods: A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant. Data were analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients
* good treatment compliance
* severe chronic insomnia
* failure of non-pharmacologic sleep therapy
* regular zopiclone therapy for 3 months or more
* regular sleep diary
* regular pain diary
* informed consent for diary review
* consent for clinical record quality assurance review.

Exclusion Criteria:

* obstructive sleep apnoea
* body mass index (BMI) ≥40
* organ insufficiency
* cognitive disorder
* inability to provide consent
* major neuropsychiatric disorder
* unreliable diary
* cannabis use
* regular alcohol intake
* stimulant use
* substance abuse
* poor treatment compliance
* high dose opioid
* gabapentinoid use
* sedative use
* mild insomina
* irregular zopiclone intake
* regular zopiclone therapy for less than 3 months
* previous adverse/allergic reactions to clonidine or zopiclone.
Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section

This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided. Combined spinal-epidural anesthesia has become the favorable technique for both elective and emergency cesarean sections. Various local anesthetics have been used, but ropivacaine is the drug of choice in most hospitals in Greece. However, chloroprocaine is a preferable local anesthetic in USA due to its quick and predictable onset of action. Chloroprocaine was initially used in 1980, but it became obsolete in those years due to neurological symptoms associated with its use caused mainly by the presence of sodium bisulfite and disodium ethylenediaminetetraacetate (EDTA) in the early formulations. Nowadays, new formulations of the drug without EDTA makes chloroprocaine safe for use.

The aim of the current randomized controlled trial will be to compare the effect of an intrathecal fixed dose of chloroprocaine versus an intrathecal fixed dose of ropivacaine in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* adult parturients, American Society of Anesthesiologists (ASA) I-II,
* singleton gestation\>37 weeks
* elective cesarean section

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) \> III
* age \< 18 years
* singleton gestation \<37 weeks
* Body Mass Index (BMI) \>40 kg/m2
* Body weight \<50 kg
* Body weight\>100 kg
* height\<150 cm
* height\>180 cm
* multiple gestation
* emergency delivery
* fetal abnormality
* fetal distress
* pregnancy-induced pathology such as preeclampsia, eclampsia, premature labor, placental abnormalities
* pregnancy- induced diseases such as hepatic failure, pseudocholinesterase deficiency, neuromuscular diseases
* lack of informed consent
* contraindication for regional anesthesia such as thrombocytopenia, coagulation abnormalities, allergy to local anesthetics
A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751

This study will determine the safety and tolerability of PF-06649751 given orally to healthy volunteers. To determine the optimal dose for future studies, the concentration of the drug over time will be determined by periodic blood samples. The rate of eye blinks will be measured as an indicator of PF-06649751 action on the receptors of interest in the brain.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
* Female subjects of non childbearing potential that meet at least one of the following criteria: Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal status; Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption.
* Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of EEG with epileptiform activity. Subjects with a history of childhood seizures, and history of head trauma with loss of consciousness requiring hospitalization overnight will be excluded as well.
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
* Intention to perform strenuous exercise to which the particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Predictors of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain

The goal of this clinical trial is to investigate about the characteristics that predict response to physiotherapy treatment in patients with nerve related neck arm pain. The main question to answer is whether there is a subgroup that responds better to physiotherapy treatment.

Participants will be assessed for clinical and neurophysiological characteristics prior to treatment. Afterwards they will receive 6 sessions of manual physiotherapy treatment along with home nerve gliding exercises once a week. Baseline measurements will be taken again after treatment to know if there have been any changes.

During the first visit, socio-demographic data will be collected. Then, participants will be assessed using the quantitative sensory testing (QST) to evaluate the excitability of the nervous system. In addition, questionnaires and scales will be used to obtain information on the psychosocial factors involved, neuropathic pain characteristics and on the disability caused by their situation.

Finally, various clinical tests will be carried out to obtain information on neck movement and irritability at closure of the intervertebral foramen, mechanosensitivity of the upper limb with neurodynamic testing and alterations in sensitivity, strength and myotatic reflexes. Also they will be asked for permission to access to their imaging tests.

Once the pre-treatment data has been obtained, the manual physiotherapy and exercise treatment will begin, which aims to reduce the irritability of the nervous system.

Once the treatment is completed, the initial measurements will be repeated along with a global rating of change scale to classify patients as responders vs. non-responders.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with unilateral cervicobrachial pain

Exclusion Criteria:

* Signs of severe disease, cervical myelopathy, tumour, rheumatic diseases or a neurological pathology of central origin.
* Cervicobrachial pain of traumatic origin or as a result of whiplash.
* Previous surgical intervention of the cervical spine.
Endoscopic Submucosal Dissection Registry

This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.

Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.

Eligibility Criteria:
Inclusion Criteria:

* epithelial pre-neoplastic (eg. adenoma, dysplasia) lesion on the esophageal, gastric, duodenal or colorectal mucosa
* non-epithelial (eg. neuroendocrine tumor) lesion on the esophageal, gastric, duodenal or colorectal mucosa
* age \> 18 years old
* informed consent

Exclusion Criteria:

* age \< 18 years old
* no informed consent
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection

This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:

1. Incidence and conditions of occurrence of adverse reactions in the clinical setting
2. Factors that may affect the safety and effectiveness of Kaletra (QD)


Eligibility Criteria:
Inclusion Criteria:

- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.

Exclusion Criteria:

* Participants with a history of hypersensitivity to any ingredient of this drug.
* Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.
Assessing Everolimus in Fist Line Treatment on Patients With Metastatic Kidney Cancer

It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis.

92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic kidney cancer, regardless of histology (except Bellini carcinomas), with measurable or evaluable disease
2. Age \>= 18 years
3. With Karnofsky ≥ 60
4. Without prior treatment for metastatic cancer (chemotherapy, targeted therapy, or mTOR inhibitor)
5. Bad prognosis, defined as follows: at least three of the following six criteria of poor prognosis:

   * Karnofsky \<80
   * LDH\> 1.5 ULN
   * hemoglobin \<LLN
   * corrected calcium\> 2.5 mmol / l (10 mg / dl)
   * Time frame between initial diagnostic and treatment \<1 year
   * More than one metastatic site
6. medullary function: neutrophils ≥ 1.5 x 109 / L, Platelets ≥ 100 x 109 / L, Hb\> 8g/dL
7. Hepatic function: bilirubin: ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN in the absence of hepatic metastasis ≤ 5x ULN if hepatic metastasis documented
8. Renal function: creatinine \<1.5 x ULN
9. Life expectancy\> 3 months,
10. Patient signed informed consent and agreeing to comply with the requirements of the trial

Exclusion Criteria:

1. Previous treatment with chemotherapy, targeted therapy, or mTOR inhibitor
2. Previous radiotherapy in the last 2 weeks
3. Chronic treatment with corticoids or immunosuppressive agents except substitutive opotherapy.. A washout period of at least 8 days must be respected before the patient inclusion.
4. Patients with brain metastases untreated or uncontrolled by prior treatment. The non-progression of the metastases must be proved by comparing two brain scans separated by a minimum interval of 6 weeks.
5. Active bleeding
6. Patient with positive serology HBs (Ag HBs (+) and AC anti-HBc (+)
7. Hypersensitivity to everolimus, sirolimus, to other rapamycin derivatives or to any of the excipients
8. Severe or uncontrolled medical pathology:

   * unstable angina, symptomatic heart failure, myocardial infarction ≤ 6 months before randomization, severe rhythm disorder,
   * Uncontrolled diabetes with glycaemia\> 1.5X ULN.
   * Active or uncontrolled infection.
   * cirrhosis or chronic active hepatitis,
   * severe alteration in lung function (\> 50% decrease in FEV or vital capacity)
9. Other cancer within the past 3 years, with the exception of basal cell carcinoma and carcinoma in situ of the cervix
10. Pregnant or lactating woman, and adults refusing an effective contraceptive method
11. Participation in another clinical trial with an investigational drug
12. Refusal of the patient to comply with the rules of the clinical trial
13. Person deprived of liberty or person under guardianship, inability to submit to medical treatment test for geographical, social or psychological reasons.
Safety and Efficacy of the Bi-Aspheric Monofocal IOL

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery. Patients will undergo a routine basic ophthalmological examination.

Additionally, and retrospectively, the patients' medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery.

The data corresponding to the preoperative values of corneal curvature (flat meridian, curved meridian and axes), axial length measured by biometry, visual acuity and those corresponding to the implanted IOL will also be collected from the medical records.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye
2. Willingness to cooperate with and complete all post-operative visits
3. Ability to comprehend and sign an informed consent

Exclusion Criteria:

1. Any pathology that could reduce Visual Acuity (VA) (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely narrow anterior chamber depth, microphthalmos, clinically significant macular/RPE changes, retinal detachment, corneal transplant, chronic sever uveitis, choroidal hemorrhage, recurrent severe inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, medically controlled or uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation).
2. Previous ocular surgery (including YAG-laser) or trauma
3. Clinically significant irregular astigmatism
4. Concomitant severe eye disease
5. Pregnant or lactating
6. Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study
7. Concurrent participation in another drug or device investigation
8. May be expected to require other ocular surgery during the study
Evaluation of Diagnosis and Treatment Methods in Corrosive Esophagitis: A 26-Year Experience-Based Algorithm

This study aims to evaluate the diagnosis and treatment methods for corrosive esophagitis based on 26 years of clinical experience. It will retrospectively analyze patient records to identify patterns in clinical outcomes, complications, and the effectiveness of treatment strategies. The study focuses on optimizing patient care by proposing a diagnosis and treatment algorithm that can guide future clinical practices. Data will be collected from hospital archives and electronic health records, covering cases of corrosive esophagitis managed at Ondokuz Mayıs University between 1998 and 2024.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with corrosive esophagitis due to corrosive substance ingestion.
* Hospitalized and treated at Ondokuz Mayıs University Thoracic Surgery Department.
* Patients who underwent clinical, laboratory, and radiological evaluations to confirm the diagnosis.
* Patients who were monitored and met follow-up criteria during their treatment.
* Age between 18 and 65 years.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients who refused hospitalization or treatment.
* Patients who ingested non-corrosive or non-toxic substances (verified by the Ministry of Health Poison Information Center).
* Patients lost to follow-up or did not complete follow-up requirements.
* Patients with incomplete data during the diagnostic or treatment process.
Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients

This protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.

* Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Concurrent Medication:

Excluded:

* Other investigational drugs.

Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.

* Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.

Prior Medication:

Excluded within 7 days of study entry:

* Other investigational drugs.

Diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS.

* Patients receiving chemotherapy for a malignancy.
* Patients who are iatrogenically immune-suppressed following organ transplantation.
Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the observed differences on the dependent variables: range of motion, pain and physical condition.

At the same time, the study will determine whether there are adverse effects or bleeding complications as a result of applied physiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* Adults patients
* Patients with hemophilic arthropathy of ankle diagnosed
* Patients in prophylactic treatment regimen or on demand treatment with concentrates of FVIII/FIX.

Exclusion Criteria:

* Patients without ambulation
* Patients diagnosed with other congenital coagulopathy (eg, Von Willebrand disease)
* Patients who have developed antibodies to FVIII / FIX (inhibitors)
* Patients with neurological or cognitive impairments that prevent understanding of questionnaires and test physical
* Patients that have not signed the informed consent document.