cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
* Migraine onset before age 50
* History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
* History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.

Exclusion Criteria:

* Difficulty distinguishing migraine headache from other headaches
* Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
* Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
* Has a chronic non-headache pain condition requiring daily pain medication
* Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
* Has a history of hepatitis within previous 6 months.
Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer

The purpose of this study is to assess quality-of-life of men with prostate cancer. "Quality-of-life" means how you feel about your life as a result of your disease and its treatment. The investigators hope that this questionnaire will help show how prostate cancer treatments affect quality-of-life. It will help doctors and future patients to make better treatment choices. Some men may wish to have a more demanding treatment with a higher risk of harmful effects. Others may prefer a treatment that will have the smallest effect on their quality-of-life.

This questionnaire will help us measure these effects and decide which is the best treatment for a given patient.

The intent of the protocol is to assess health-related quality-of-life (HRQOL) in men treated for localized prostate cancer with 1 of 6 established management alternatives: external (XRT)or interstitial radiotherapy (IRT), open radical prostatectomy (RP), laparoscopic radical prostatectomy (LRP), combined radiotherapy and brachytherapy (Combined RT) or watchful waiting (WW). HRQOL is an important aspect of any treatment for prostate cancer due to the beliefs by many that cancer control rates are similar across common modalities and HRQOL reduction from treatment is substantial (1-5). Therefore, HRQOL appears to occupy a central role in the decision making process related to treatment selection.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of localized, untreated prostate cancer (clinical stages T1-3, Nx, M0)
* ability to read the English language

Exclusion criteria:

* other cancer diagnosis for the past three years, except for non-melanoma skin cancer
* prior chemotherapy within the last three years; radiation therapy to the pelvis or prior pelvic surgery within the past three years
* prior neoadjuvant therapy, such as hormones (Bicalutamide use for less than or equal to 1 month would not constitute exclusion from study entry)

For the cross-sectional component of the study, all patients identified to be free of disease at least ten years post -treatment will be considered eligible. Patients must have no clinical evidence of local, regional or distant recurrences. Patients must have the ability to read and understand English. Patients who received hormonal therapy will be eligible for the cross-sectional component of the study, but the duration of the hormonal therapy must be six months or less. the investigators have identified a cohort of patients who fit these criteria from our databases.
Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision

Living donor liver transplantation (LDLT) is an important option for patients with end-stage liver disease requiring liver transplantation. When performing LDLT, the safety and well being of donors is of the utmost importance. The conventional incision for donor hepatectomy is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive liver surgery throughout a single 10 cm upper midline incision without laparoscopic assistance has been widely applied and considered to be safe and effective. Recently, laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been suggested to reduce morbidity and the invasiveness of living donor hepatectomy. Although minimally invasive approach has become the surgical method of choice for many transplant centers, little data on comparing the impact of all three different type incision in living liver donors. In our center, the investigators have adopted three different incision according to surgical teams. The investigators undertook this study with the aims of comparing the pain and quality of life of donors according to type of three different incisions and assessing any benefits to the donor due to the smaller midline incision during the early postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status I-II,
* adult undergoing hepatectomy for living donors

Exclusion Criteria:

* known allergy to any of the drugs used in this study,
* bleeding diathesis,
* neurologic dysfunction (preexisting lower limb neurological deficit),
* recent systemic or local infections,
* history of drug use, or
* under treatment with opioids because of chronic pain
Alteration of the Immune Response in Bacterial Infection

The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.

In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.

It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* BMI 18 to 25
* presence of a bacterial infection
* pneumopathy (documented or probable)
* acute pyelonephritis / prostatitis
* skin and soft tissue infection (erysipelas, fasciitis, excluding pressure ulcers)
* cholecystitis / cholangitis,
* surgical site infection
* signed informed consent

Exclusion Criteria:

* patients with documented viral, parasitic or mycotic infections
* patients with bacterial infection\> 4 weeks (eg endocarditis, osteoarticular infections)
* patients followed in intensive unit care
* patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years
* patients with systemic diseases (connective tissue diseases, vasculitis)
* known immunodepression syndrome (CVID, HIV ...)
* immunosuppressive therapy in progress until less than one month before inclusion (corticosteroids, DMARDs, biotherapies, hydroxychloroquine)
12-Month Stability of Diurnal IOP Control on Cosopt

To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.

Eligibility Criteria:
Inclusion Criteria:

* bilateral open-angle glaucoma

Exclusion Criteria:

* contraindications to Cosopt
* pathology affecting tonometry
Study to Evaluate the Efficacy of Riluzole in Children and Young Adults With Spinal Muscular Atrophy (SMA)

This is a multicentric, randomized, double-blind study versus placebo, with two parallel groups treated to evaluate the efficacy and the tolerance of Riluzole in children and young adults (6 to 20 years of age) with SMA. (Type II and Type III).

ASIRI study should allow to evaluate the efficacy and the tolerance of Riluzole in children and young adults (6 to 20 years of age) with SMA. This is a multicentric, randomized, double-blind study versus placebo, with two parallel groups treated and followed during 2 years. It has been preceded by a 7 days pharmacokinetic phase, concerning 14 patients, aiming to provide information on the kinetic profile of Riluzole in children. The drug could stabilize patients condition, and especially interrupt paralysis progression; those are the desired effects.

There is an open-label study of the long term safety of riluzole therapy in spinal muscular atrophies types II and III, with patients previously enrolled in ASIRI double-blind study.

Eligibility Criteria:
Inclusion Criteria:

* Patients afflicted with spinal muscular atrophy, type II or III, with genetic defect confirmed.
* Age between 6 and 20 years old.
* Score MFM at least 12
* Negative pregnancy test for women of child-bearing age
* Signing of an informed consent form, after appropriate information has been provided (if the patient is under 18 years old, both parents are required to sign the form too; otherwise, only her (his) agreement is necessary).

Exclusion Criteria:

* Patients already treated with Riluzole
* Concomitant treatment with: GAPAPENTINE, DEXTROMETHORPHANE, amantadine, any hepatotoxic medication that cannot be stopped, any other experimental product
* Hepatic insufficiency: SGPT and/or SGOT levels higher than or equal to twice the normal higher limit
* Renal insufficiency (creatinine above 115 micromoles/l)
* Severe cardiac insufficiency
* Current pneumopathy (clinical signs of an acute episode, confirmed by pulmonary X-ray, requiring specific treatment)
* Pregnancy or nursing for women; non-abstinence or absence of effective contraception for nubile women
* Any pathology or other circumstance likely to interfere with a regular follow-up
* No affiliation to any social insurance system
Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

A monitoring system was developed for detecting upper gastrointestinal (UGI) rebleeding. This system consists of (1) a tiny endoscopy, (2) a wearable device, and (3) a software. The endoscopy is inserted to UGI tract via nasal cavity and then stayed there for 3 days. The wearable device is set to regularly receive the pictures from the endoscopy and sent to the software, which is able to automatically analyze whether the rebleeding occurs. This study aims to test the feasibility and efficacy of the monitoring system.


Eligibility Criteria:
Inclusion Criteria:

* "Rockall" score ≧3

Exclusion Criteria:

* Pregnant woman;
* Behavioral disorder;
* Major cognitive-perceptual deficit;
* The person who has a nasogastric (NG) tube;
* Other deficits or disorders that are not suitable for NG insertion;
* Participants who need to take MRI scan.
Contribution of Skin Color in Stabilization of Active Cases of Vitiligo by Narrow Band UVB

Vitiligo is a disease in which autoimmunity plays a major role. Multiple treatment options are available, of which narrow-band UVB is a cornerstone, acting through immunosuppression and repigmentation by stimulating reservoir melanocytes.

It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier.

Vitiligo is acquired depigmentation disorder. Several theories were hypothesized for causing vitiligo, of which the autoimmune theory is the most accepted.

The main targets of therapy are stabilization of the disease activity through immunosuppression, and repigmentation through stimulation of reservoir melanocytes proliferation and migration.

Narrow band ultraviolet phototherapy (NB-UVB) remains the cornerstone treatment of vitiligo. NB-UVB can induce both immunosuppression and repigmentation. Several factors can modulate the efficacy of NB-UVB therapy in treatment of vitiligo cases, including patient's age, lesion site, duration of the disease, and duration of the therapy.

The immunosuppressive function of NB-UVB was first detected in 1963 by Hanisko and Suskind, who observed that the contact hypersensitivity response in skin sensitized to dinitrochlorobenzene (DNCB) was reduced if skin was previously exposed to suberythemal doses of UVB.

Present evidence suggests that UVB suppress immune system through generation of T-suppressor cells, which inhibit the effector cells of Th1 type. It appears that UV-induced immunosuppression depresses the function of Th1 cells and enhances the activity of Th2 cells via cytokines such as Interleukin 10.

It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier. However, skin was previously divided to UVB-resistant and UVB-sensitive (UVB-R and UVB-S) based on the contact hypersensitivity testing, regardless of the skin type. Moreover, A study on NB-UVB phototherapy for psoriasis revealed that photoadaptation during NB-UVB therapy Is Independent of skin type.

Eligibility Criteria:
Inclusion Criteria:

* Active cases of non-segmental vitiligo, VIDA +2 or more.
* All skin types
* Age above 6 years, both sexes.

Exclusion Criteria:

* Contraindications to NB-UVB ( photosensitive skin disorders, skin malignancy, patients on photosensitizing medications)
* Contraindications to mini-pulse steroid therapy (uncontrolled diabetes or hypertension, peptic ulcer)
* Stable disease (VIDA 0 \& -1) and activity more than 6 months ago (VIDA +1).
* The use of other treatment for vitiligo during the 3 months previous to enrollment.
LDCT Chest In Assessment Of Apparently Healthy Smokers

To evaluate the effectiveness of LDCT screening in detecting early-stage lung cancers among smokers who do not have symptoms of lung disease.

Tobacco smoking is the leading preventable cause of death worldwide .Chronic Obstructive Pulmonary Disease (COPD), lung cancer, and cardiovascular disease will be responsible for the majority of deaths in the developed world in the coming decades .

COPD is characterised by chronic airflow limitation caused by a combination of small airway inflammation and parenchymal destruction (emphysema) . Since computed tomography (CT) has been validated as a non-invasive technique capable of identifying areas of lung parenchyma with emphysema , several studies have identified a subgroup of apparently healthy smokers who have emphysema but no airway obstruction Furthermore, this subgroup has the highest risk of developing lung cancer among smokers .It has been proposed that systemic inflammation may play an important pathogenic role in carcinogenesis . We will conducted this cross sectional study between. current and former smokers without airway obstruction participating in a lung cancer screening study: a study group of smokers with emphysema on the CT, and a control group of smokers without emphysema.

Eligibility Criteria:
Inclusion Criteria:

- Participants have at least 45years old had smoked 10 pack-years or more

Exclusion Criteria:

* Age: less than 45 years. Non smoker Evidence of airway obstruction by Pulmonery Function Test
Evaluation of the Analgesic Efficacy of Multimodal Pain Control Regimens That Aim to Limit the Use of Narcotics in Cholecystectomy and Hernia Repairs

Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. I

This performance improvement study is a retrospective review of data obtained from patients at Methodist Mansfield Medical Center (MMMC) in Mansfield, Texas from May 1, 2022 to September 30, 2022. Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. Incisional hernias were excluded. Emergent hernia operations that required bowel or colon resections due to strangulation were excluded

Eligibility Criteria:
Inclusion Criteria:

Patients of the five physicians of the SAM group Patients ≥18 years Patients undergoing urgent or elective laparoscopic and robotic cholecystectomy OR patients undergoing urgent or elective laparoscopic, robotic or open hernia repair (ventral, umbilical, or inguinal).

Exclusion Criteria:

Patients \<18 years Patients with chronic pain conditions managed with chronic use of narcotics Patients that underwent incisional hernia repairs Patients that underwent complicated hernia repairs that included other operations such as colon and bowel resection procedures
Examination of the Applicability and Performance of Otolaryngology Telemedicine, Telediagnostics in Establishing the Diagnosis and Therapy of Otolaryngology Diseases

System/Device name: Otoscopic recording and clinical data telemedicine software supporting its transmission and analysis.

Characteristics of the medical device:

The device is applied to an iPhone with a CE mark also from a CE-marked optical unit and the system operator, a consists of software under investigation.

The detailed operation is in the user guide in Hungarian included. The device makes a video recording of the external ear canal and about the tympanic membrane, and it records clinical data (symptoms, complaints).

The telephone application sends the data through the system to a doctor, who, by analyzing them, makes a diagnosis and provides therapy.

The study is a prospective, single-arm study. The specialist treating the real patient (called doctor 2) does not see or know the diagnosis and the therapy from the telemedicine system, or the recommendation from the telemedicine The diagnosis and therapeutic treatment established by the two methods are evaluated by an independent specialist and decides whether the primary diagnosis and therapeutic treatment are the same or not in the telemedicine system.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Patients with ear complaints (especially, but not exclusively, ear pain from the ear discharge, itching, cerumen accumulation,)
* The subject communicates well with the investigator and is able to understand the requirements of the test plan and to help with compliance.

Exclusion Criteria:

* Poor general condition
* Based on the investigator's decision, a condition that directly threatens life or a symptom that corresponds to these may indicate (e.g.: Liquor dripping, massive bleeding, etc.)
* Any disease that, in the investigator's opinion, endangers the patient's health and/or contraindicates performing the test
* The examiner finds that further participation is a disadvantage for the patient for any reason;
* the patient requests the suspension of his participation orally or in writing
A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)

The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as assessed by hemoglobin maintenance, adverse events and health-related quality of life.

Epoetin alfa has been widely utilized as treatment for anemia associated with Chronic Kidney Disease (CKD). Epoetin alfa has been shown to increase hemoglobin (Hb) levels by an average of 1.5 g/dL to 2 g/dL in these patients over 12 weeks (Data on file Ortho Biotech Products, L.P.). This improvement in Hb levels is maintained while the patient is receiving Epoetin alfa and is associated with significant improvements in survival, exercise tolerance, and quality of life. Literature has suggested that epoetin alfa can be given less frequently and still maintain an optimal hemoglobin while also allowing patient's greater convenience. This study will further confirm that less frequent dosing of epoetin alfa is safe and effective. This is an open-label, randomized multicenter study in patients with CKD. CKD patients who are currently receiving PROCRIT therapy for at least 2 months or more and with a stable Hb (\>= 11g/dL) will be randomized to one of four treatment groups. A stable Hemoglobin will be defined as a value that is ± 10% for 3 consecutive laboratory values.

This study is designed to demonstrate that there is no meaningful difference in hemoglobin level with more extended dosing regimens as compared to once weekly. A clinically meaningful difference is defined as a difference that is less than 10%. Patients will be randomized to one of 4 treatment groups: All will receive subcutaneous (under the skin) Epoetin alfa for a period of 16 weeks.

Group 1: 10,000 units every week Group 2: 20,000 units every two weeks Group 3: 30,000 units every three weeks Group 4: 40,000 units every four weeks

Eligibility Criteria:
Inclusion Criteria:

* CKD patients (defined as serum creatinine 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 g/mg/dL for men)
* Stable Hb (\>= 11.0g/dL) and currently receiving PROCRIT therapy for 2 months or more. A stable Hemoglobin will be defined as a value that is ± 10% for 3 consecutive laboratory values.

Exclusion Criteria:

* Lactating or pregnant women
* Uncontrolled hypertension
* Known hypersensitivity to mammalian cell-derived products and human albumin
* Receiving dialysis or scheduled to receive dialysis during the course of the study
* gastrointestinal bleeding
* Severe Congestive Heart Failure (New York Heart Association Class IV)
* Concurrent chemotherapy for cancer
* History of/or active blood disorders, liver diseases or seizures
* HIV positive
* Received a kidney transplant