cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.

This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of celecoxib.

The study was conducted as a randomized, 2-period, 2-sequence, cross-over study to determine the effect of a single dose of ALXN1840 (perpetrator) on the single-dose celecoxib (victim) kinetics in healthy male and female participants.

The study had a Screening period (Day -28 to Day -2), two 11-day study periods (Day 1 to Day 11) with a minimum of 14 days between doses of celecoxib, and an End of Study Visit (Day 15 ± 2 days) after Period 2 dosing. Participants only reported to the clinical research unit (CRU) on the day prior to the first dose because they were kept in the CRU during the wash-out period due to coronavirus disease 2019.

All participants received a single dose of celecoxib alone (Treatment A) and celecoxib coadministered with ALXN1840 (Treatment B) during the study, 1 in each treatment period. Based on randomization, participants were administered either Treatments A-B or Treatments B-A in each study period.

The PK profile of ALXN1840 and celecoxib was determined by blood sampling following single-dose administration. In addition to PK sampling, safety and tolerability were assessed by monitoring adverse events, vital signs, 12-lead electrocardiograms, physical examinations, and laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Adequate venous access in the left or right arm to allow the collection of blood samples.
* Bodyweight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to \< 30 kg/meter squared.
* Willing and able to follow protocol-specified contraception requirements.
* Capable of giving signed informed consent.

Exclusion Criteria:

* History or presence of/significant medical history.
* Clinically significant multiple or severe allergies.
* Lymphoma, leukemia, or any malignancy within 5 years.
* Breast cancer within the past 10 years.
* Serum creatinine \> upper limit of normal (ULN) of the reference range.
* Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> ULN.
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* QTc \> 450 milliseconds (msec) for male participants or \> 470 msec for female participants.
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure

The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.

Severely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries.

Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions.

However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.

The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.

Severely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries.

Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions.

However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.

The aim of this study is to compare the healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout). The secondary endpoints were stent placement success (defined as expansion with \<20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure), procedure time, radiation exposure, periprocedural and in-hospital complications, and major cardiovascular adverse events at medium-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years.
* Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 for 3 months or more
* Stenosis ≥70% in a coronary artery with a diameter ≥2,5 mm.
* Severe angiographic calcification (affecting both sides of the arterial lumen)
* Any clinical scenario except acute myocardial infarction in the first seven days of evolution.
* Native coronary vessel or bypass graft.

Exclusion Criteria:

* Absence of informed consent.
* Acute myocardial infarction in the first 7 days of evolution.
* Lesion in a single patent vessel.
* Calcified lesions with an angulation \>60º, dissections, lesions with thrombus, and degenerated saphenous vein grafts.
* Hemodynamically unstable patients
* Patients with allergy to iodinated contrast media
* Patients with significant comorbidity and with a life expectancy of less than one year
Effect and Feasibility of Non-linear Periodized Resistance Training in People With COPD

This study aims at improving the knowledge about resistance training for people with COPD. Resistance training is an important part of pulmonary rehabilitation when the goal is to improve muscular endurance and strength. The study will evaluate the effects and the feasibility of two resistance training programs for people with COPD using a parallel group design. One program will include a larger day-to-day variation (i.e. non-linear periodization) and the progression will be guided by ratings of dyspnea, muscle fatigue, and exertion. The other program will follow the established guidelines for resistance training for people with COPD. The programs will be evaluated for effects regarding muscular endurance, strength, intramuscular adaptions, functional preformance, dyspnea, and health related quality of life. The programs will also be evaluated for feasibility regarding the duration of training sessions, attendance rates, adverse events, and participant satisfaction. The hypothesis is that the non-linear periodization group will have superior effects and that feasibility aspects will be similar between groups.


Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC ratio \< 70% postbronchodilator
* FEV1 \<80% of the predicted normal value postbronchodilator

Exclusion Criteria:

* Clinical evidence of asthma, cardiovascular diseases, and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation
* Other contraindications to exercise
* Currently participating in a structured exercise or pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months
* Experienced a COPD exacerbation and/or change in medication dosage/frequency in the past 6 weeks
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

This study will assess the efficacy, safety and tolerability of topically administered diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size of erythema along the superficial vein)


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb
* Spontaneous or iatrogenic superficial thrombophebitis of the upper limb

Exclusion Criteria:

* Hypersensitivity to the study drug, to actylsalicyclic acid and other non-steroidal antirheumatic agents and to the ingredients of the gel
* Paitents who had developed asthma, skin reactions or acute rhinitis to acetylsalicylic acid or other non-steroidal antirheumatic agents in the past
* Therapy with varicose vein remedies, antithrombotic or antiphlogistic agents as well as corticosteroids for more than 7 days prior to study start
* Acute deep vein thrombosis and thrombophlebitis extending into other deep veins

Other protocol-defined exclusion criteria may apply
Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a confirmed diagnosis of epilepsy.
* Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
* Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion Criteria:

* Need for an additional AED.
Ultrasound Versus Kinesiotaping in Shoulder Impingement Syndrome

studying the effect of ultrasound and kinesiotaping in shoulder impingement syndrome in reliefing pain and increase range of motion in subjects with shoulder impingement syndrome .

Shoulder pain is a common presenting complaint from patients of all ages in daily clinical practice, affecting approximately one-third of individuals during their lifetime. Such pain may lead to the impairment of shoulder joint function and to severe reduction in quality of life. Shoulder impingement syndrome.

Ultrasound (US) is a physical therapy agent that is frequently used as an adjunctive treatment for shoulder pain. US has thermal and biophysical ffects which provide analgesia increases nutrition and increases blood circulation.

Kinesio taping method (KT), has been widely used also for many musculoskeletal diseases including shoulder problems. Most of taping methods are aimed to provide a mechanical stimulus for proprioception or to decrease pain by lifting skin and subcutaneous tissues.

* To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on pain intensity.
* To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on shoulder ROM.
* To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on shoulder function.
* To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on hand strength.

Eligibility Criteria:
Inclusion criteria:

1. Patients with shoulder impingement syndrome from both genders their age will be ranged and divided into three groups from 20-50 years.
2. History of shoulder pain for one month.
3. Positive Neer's impingement test and Hawkin's kiennedy test.
4. Provocation of pain above 60 degrees of flexion and abduction.

Exclusion criteria:

1. History of Shoulder girdle fracture, dislocation and surgery
2. Diagnosed with frozen shoulder or rotator cuff tear
3. History of cervicobrachial pain
4. Any neuromuscular pain in upper limb and use of corticosteroids or pain subsiding medication
Esophageal Motility Disorders in Patients With Non-cardiac Chest Pain at Assiut University Hospital

to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring

Non-cardiac chest pain (NCCP) is defined as recurrent anginalike pain without evidence of cardiac disease \[1\]. NCCP is a common disorder and accounts for 14-33% of patient visits to gastroenterologists \[2\]. These patients frequently undergo testing for reflux and esophageal motility as gastroesophageal reflux disease (GERD) is seen in 50-60% and esophageal motility disorders in 15-18% of the patients \[3,4\]. Nutcracker esophagus was thought to be the classic manometric finding in NCCP \[5\] but other studies have reported ineffective esophageal motility (IEM) as the most common motility disorder in NCCP \[6,7\]. Furthermore, up to one-third of patients do not have any GERD or motility disorders and are labeled as functional chest pain \[8\]. Suggested causes in these patients include esophageal hypersensitivity \[9\], abnormal cerebral pain processing and psychological comorbidity \[10\]. The clinical predictors of abnormal esophageal function tests in NCCP have not been identified. Identifying these factors would lead to limited use of testing in those with risk factors and faster institution of pain modulator therapy in patients who are most likely to have functional chest pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years
2. Patients presented with non-cardiac chest pain

Exclusion Criteria:

* 1- age below 18. 2- cardiac chest pain patients
Nephronophthisis : Clinical and Genetic Study

to describe evolution of Nephronophthisis

To specify the long term evolution of Nephronophthisis in terms of renal disease as well as extra-renal damages for patients having a confirmed diagnosis of NPHP1, NPHP2, NPHP3, NPHP4, NPHP5, NPHP6 or NPHP8 gene mutation

Eligibility Criteria:
Inclusion Criteria:

* NPHP1, NPHP2, NPHP3, NPHP4, NPHP5, NPHP6 or NPHP8 gene mutation
* 7 years old and older

Exclusion Criteria:

* MRI contra-indications
Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke

To determine if the Trevo Retriever is as good or better than the Merci Retriever in restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a large vessel.

The TREVO 2 protocol was designed to assess the safety and effectiveness of the Trevo Retriever device and determine if it is substantially equivalent to the predicate Merci Retriever. The trial utilized a Primary Effectiveness Endpoint of revascularization and a composite Primary Safety Endpoint that included procedure-related serious adverse events occurring within 24 hours of the procedure. Subjects who presented to enrolling centers with large ischemic strokes were screened for eligibility in the study. If a subject met eligibility criteria, then Informed Consent was obtained prior to commencing the angiogram. If all inclusion/exclusion criteria were confirmed, including the angiographic criteria, then the subject was randomized.The Primary Effectiveness Endpoint was successful revascularization of the target occlusion, using the TICI score. Success was determined by the central Core Lab.The Primary Safety Endpoint is a composite endpoint, described in the protocol as the "Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours) defined as: vascular perforation or intramural arterial dissection, symptomatic ICH, embolization to a previously uninvolved territory, access site complication requiring surgical repair or blood transfusion, intra-procedural mortality, device failure (in vivo breakage), or any other complications judged by the Clinical Events Committee (CEC) to be related to the procedure."

Eligibility Criteria:
Key Inclusion Criteria:

* Patient presenting with clinical signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, and:

  * Patient has failed IV t-PA therapy Or
  * Patient is contraindicated for IV t-PA administration
* NIHSS 8 \< NIHSS \< 29
* Anticipated life expectancy of at least 6 months
* No significant pre-stroke disability (mRS \< 1)
* Written informed consent to participate given by patient or legal representative
* Angiographic confirmation of a persistent large vessel occlusion in the internal carotid, middle cerebral (M1 and/or M2 segments), basilar and/or vertebral arteries
* Treatable within 8 hours of symptom onset, defined as the first pass being made with the assigned study device

Key Exclusion Criteria:

* Abnormal blood pressure and/or blood coagulation lab values
* Pregnancy
* Patient participating in another investigational drug or device study
* More than 1/3 of MCA or equivalent in non-MCA territory
* Baseline evidence of significant mass effect with midline shift, or hemorrhage, or intracranial tumor
* Bilateral stroke
Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)

This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who undergo lung transplantation and azathioprine tablets were administered

Exclusion Criteria:

* Subjects with hypersensitivity to the ingredients of azathioprine tablet
* Subjects who is pregnant or might be pregnant
* Subjects whose white count is lower than 3000/cubic millimeter
A Clinical Study to Assess the Efficacy and Safety of DA-3002

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Turner's Syndrome through chromosome analysis
* The chronological age: 2≤AGE≤12
* The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
* Before the adolescence, Tuner stage I (breast)
* Normal thyroid function

Exclusion Criteria:

* Growth hormone was administered for 12 months or longer in the past
* Treated with estrogen or adrenal androgens for 12 months or longer in the past
* Malignancy, CNS Trauma, Psychiatric Disorder
Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer

In the current study FDG (Fluorodeoxyglucose) uptake, FLT uptake (F18-Fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor.

Several publications have addressed the role of PET imaging for biological characterization of breast cancer. A modest but significant correlation was reported between tumor grading and FDG uptake. Few studies reported a positive correlation between SUV and the Ki-67 labeling index of malignant breast tumors. Others have correlated p53 expression in breast cancer and FDG uptake. F18-Fluoro-3'-deoxythymidine (FLT) has been developed as a PET marker for cellular proliferation has been developed for imaging cell proliferation and findings correlate strongly with the Ki-67 labeling index in breast cancer. A 10-minute FLT-PET scan acquired two weeks after the end of the first course of chemotherapy, has been shown in two recent studies to be useful for predicting longer-term efficacy of chemotherapy regimens for women with breast cancer.

In the current study FDG and FLT uptake and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor. It is our hypothesis that since high uptake of these tracers implies aggressive behavior and rapid tumor growth, it might well be that patients with high risk score on Oncotype will have high uptake of the PET tracers and those with low risk score will show low-intensity uptake values. If this will be the case, it might well be that in patients with non-conclusive oncotype results (intermediate score) FDG and FLT uptake measurement will allow further dichotomy to 1. Patients with intermediate score on Oncotype and high uptake of the PET tracers, suggestive of aggressive behavior and 2. Patients with intermediate score on Oncotype and low uptake of the PET tracers suggesting a less aggressive behavior.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with breast cancer
* clinically nodal negative
* prior to surgery and/or treatment
* age over 18 years

Exclusion Criteria:

* Age under 18
* Pregnancy
* Previous therapy for breast cancer
* Clinical or histological evidence of nodal involvement or other proven metastatic sites
Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.

The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to Calcitonin Gene Related Peptide (CGRP)infusion.

Calcitonin Gene Related Peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in approximately 50% of migraine sufferers. Treatment of spontaneous migraine attacks with an antagonist to CGRP is effective in many patients. These data show that CGRP is involved in both initiation and maintenance of migraine attack.

The consequence of migraine gene mutations on relevant migraine pathways has never been tested. The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to CGRP infusion. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility Criteria:
Inclusion Criteria:

Patients: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) caused by mutations in the CACNA1A gene and the ATP1A2 gene.

Controls: Healthy volunteers

Exclusion Criteria:

Controls: No primary headache in their own history 2) Patients and controls:

* A history of cerebrovascular disease and other CNS- disease
* A history of serious somatic and mental disease
* A history suggesting ischaemic heart disease
* A history of hypo- or hypertension
* Daily intake of medication apart from oral contraceptives
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.

On the study day:

* No intake of a simple analgesic in the previous 48 hours
* No headache in the previous 48 hours