cyrilzakka/clinical-trials huggingface dataset:
Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis

Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as compared with 50 mg/day topiramate.

Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as compared with 50 mg/day topiramate.

We conducted a prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Patients with CM were randomized (1:1) to flunarizine and topiramate treatment groups.

This study consisted of two periods: a prospective baseline screening period lasting up to 2 weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks 0-8, T1-T4).

The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance period (T2-T4). During the titration period, subjects were given 25 mg/day topiramate or 5 mg/day flunarizine once daily in the first week, followed by 50 mg/day topiramate or 10 mg/day flunarizine in divided doses (twice daily) in the second week. When subjects could not tolerate this target dose, the initial dose was continued through T4.

Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected and directed to the outcome evaluators, who were blinded to the patients' treatment.

The primary outcomes assessed were the reductions in the total numbers of headache days and migraine days after 8 weeks of treatment (weeks 7 to 8 vs. weeks -2 to 0). Secondary outcomes were reductions in the numbers of days of acute abortive medication intake and acute abortive medication tablets taken, and the 50% responder rate.

Eligibility Criteria:
Inclusion Criteria:

* ICHD-IIR criteria for CM (as reported by the patient)
* Experienced ≥7 days of headache lasting ≥30 min during T0 (-2 week to 0 week).
* On ≥4 of these days, subjects were required to have experienced migrainous headache
* Prophylaxis-naïve (i.e., patients could not receive any preventive medications)
* With and without medication overuse

Exclusion Criteria:

* Headache type other than CM
* Migraine onset after the age of 50 years
* CM onset after the age of 60 years
* Previous history of migraine prophylaxis before enrollment
* Pregnancy or nursing status
* History of hepatic or renal disorder, nephrolithiasis or other severe systemic disease
* Severe depression (BDI score ≥ 30 at visit 1)
* Conditions incompatible with MRI, such as claustrophobia or metallic or electric implants
Development of Visual Function Evaluation Method

The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient

This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.

Eligibility Criteria:
Inclusion Criteria for patients with retinitis pigmentosa:

* Age: ≥ 20 years
* Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent

Inclusion Criteria for healthy Volunteers:

* Age: ≥ 35 and ≤ 75 years
* Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening

Exclusion Criteria:

* Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
* Subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
* Pregnant women
* Subjects who are judged that continuation of the study is difficult during the study period
* Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
MR Guidance for Liver and Pancreas

This is a single centre, single arm, prospective feasibility study that aims to see whether magnetic resonance imaging (MRI) as a source of image guidance before each radiation treatment fraction is feasible, and also if it may provide information that could potentially be used during the treatment to improve the radiation treatment plan.

Patients will have 5 MRIs with each of their RT sessions. If patients' RT treatment will consist of more than 5 fractions, only 5 MRIs will be done with any 5 RT fractions. Patients will be completing a short questionnaire at the end of each MRI. A patient questionnaire will also be completed at the end of the study to assess for patient satisfaction.

There will be 30 evaluable patients enrolled to the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Diagnosed with locally advanced pancreatic cancer or hepatocellular carcinoma being considered for treatment with chemoradiation, long course RT, or SBRT with curative intent or palliative intent, planned for 5 or more RT fractions

Exclusion Criteria:

- Contraindications for MRI: ferromagnetic prosthesis, pacemaker / implanted defibrillator, claustrophobia
A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors

This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced or metastatic malignant solid tumors;
* Patients failed the standard anti-tumor therapy or don't have standard regimen;
* At least one measurable lesion;
* At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed;
* Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0);
* ECOG performance status 0-1;
* Life expectancy ≥ 3 months;
* Adequate hematologic function: ANC ≥ 1.5 × 10\^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10\^9 /L;
* Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN);
* Adequate renal function: creatinine ≤ 1 × ULN;
* Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
* Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose.

Exclusion Criteria:

* HCV, TP or HIV antibody positive;
* Previously received anti-VEGF protein drugs, such as bevacizumab;
* Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck;
* Active hepatitis B infection;
* Evidence of serious infection;
* Symptomatic brain metastases;
* Patients with proteinuria at screening (urine protein ≥ 1+);
* History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
* Serious non-healing wounds, ulcers or fractures;
* Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment;
* Active bleeding within 3 months prior to enrollment;
* Bleeding diathesis or coagulation disorder;
* History of arterial or venous thrombosis;
* History of myocardial infarction or stroke within 6 months prior to enrollment;
* Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mmHg);
* Pregnant and lactating women;
* Known allergies to any excipient in the study drug;
* Patients with alcohol or drug dependence;
* Participation in other clinical trials within 4 weeks before enrollment.
Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level

Purpose of this study is to determine whether keeping SAA on normal or near normal level will delay progression of renal failure in patients with amyloidosis secondary to FMF.

FMF is an inherited inflammatory disorder typically presented in most causes as recurrent episodes of fever and serositis. Phenotype II, another kind of this disorder, has atypical courses, when the inflammation proceeds without any clinical sign.

Each FMF attack is accompanied by sharp elevation of inflammatory markers in the serum, and serum amyloid A (SAA) one of them. The level of these inflammatory markers returns to normal with termination of the attack. The SAA is the main component of amyloids fibrils and constantly high level of SAA after the attack (as occurs in undiagnosed or undertreated disease) is the significant risk factor responsible for development of amyloidosis. On the other hand, in patients with phenotype II the amyloidosis occurs despite absolute absence of the attacks.

The kidney is one of the first organ suffers from amyloid deposits. The spectrum of kidney damage spread wildly from mild proteinuria to obvious nephrotic syndrome with disturbance in renal function and progression to end stage renal failure.

It is well known that deterioration of renal disease in AA amyloidosis links to level of SAA in serum. The permanently high SAA level is a major factor responsible to progression of renal disease. Occasionally, however, decline in the renal function occurred despite normal or near normal levels of SAA. Renal impairment in these cases may be explained by mechanisms existing in other kidney diseases when uncontrolled proteinuria aggravates renal dysfunction. The purpose of the study is to find whether a cohort of patients followed in our clinic and receiving colchicine for FMF- amyloidosis according to the SAA levels, monitored periodically, have better prognosis than an historical cohort receiving colchicine according to the attack status

Eligibility Criteria:
Inclusion Criteria:

* FMF patients with amyloidosis AA
* 18 year and older

Exclusion Criteria:

* patients with AA amyloidosis not related to FMF
* evidence of other primary renal disease or renovascular pathology
* evidence of renal disease secondary to any systemic illness
* presence of inflammatory, autoimmune conditions or chronic infection that could lead to high SAA level
* pregnancy
* inability to provide legal consent
Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy

Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney. Interruption of renal blood flow via pedicle clamping is often necessary during partial nephrectomy, especially for complex tumors with deep parenchymal invasion. Ischemia-reperfusion injury is a complex process involving several mechanisms including renal vasoconstriction, extensive tubular damage and glomerular injury. The investigators will examine the postoperative renal function of patients who received intraoperative ketorolac and remote ischemic preconditioning during partial nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA l and ll
* age 20-65
* patients undergoing partial nephrectomy

Exclusion Criteria:

* preoperative liver or renal dysfunction,
* coagulopathy,
* chronic alcoholism,
* hypersensitivity of NSAID,
* history of warfarin,
* history of gastric ulcer
Predicting Response to Capecitabine in Women With Metastatic Breast Cancer

RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment.

PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer.

OBJECTIVES:

Primary

* To determine the sensitivity, specificity, and positive and negative predictive values of dihydrouracil/uracil (UH_2/U) ratio measured before starting treatment on grade 3-4 capecitabine-related toxicity in women with metastatic breast cancer.

Secondary

* To prospectively test the value of the germinal genotype of thymidylate synthase (TS) and methylenetetrahydrofolate reductase (MTHFR) as predictors of resistance to capecitabine.
* To evaluate the practical feasibility of such pre-therapeutic screening.
* To determine the sensitivity, specificity, and positive and negative predictive values of dihydropyrimidine dehydrogenase genotyping on grade 3-4 capecitabine-related toxicity in the first and second courses.
* To evaluate the predictive gain provided by genotyping relative to phenotyping alone.
* To evaluate the influence of TS and MTHFR gene polymorphisms on clinical response and duration of response.
* To evaluate the pharmacokinetics of capecitabine and its metabolites and their relationship with UH_2/U and genotype.
* To evaluate the total cost of pre-therapeutic phenotyping alone and the combination of phenotyping and genotyping.
* To exhaustively analyze the 23 exons of the dihydropyrimidine dehydrogenase (DPYD) gene in patients who developed toxicity.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected 8-15 days before the start of treatment and periodically on the first day of treatment for dihydropyrimidine dehydrogenase phenotyping (dihydrouracil/uracil ratio and high performance liquid chromatography analysis), genotyping (4 most relevant single nucleotide polymorphisms), and pharmacokinetic analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Radiologically (by scintography) or histologically confirmed metastatic breast cancer
* At least 1 measurable or evaluable target lesion
* Receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab)
* No uncontrolled brain metastases
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Life expectancy ≥ 3 months
* Fertile patients must use effective contraception
* No chronic uncontrolled illness
* No congestive heart failure
* No peripheral venous disease
* No severe uncontrolled infection
* No hypoxemic respiratory failure
* No prior primary cancer except for basal cell carcinoma of the skin
* No psychologic disorder

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No capecitabine co-administered with chemotherapy
Oral Peanut Immunotherapy for Peanut Allergic Patients

This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.

The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy (IT) have been unsuccessful primarily because of the side effects of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 1 and 16 years of age
* Diagnosed peanut allergy by either: 1) a positive prick skin test to peanut, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanut, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
* A family that will be able to be compliant with all study visits.

Exclusion Criteria:

* Subjects with a history of severe anaphylaxis to peanut
* Subjects with a medical history that would prevent a DBPCFC/OFC to peanut The medical history that would prevent the DBPCFC to peanut would be a prior history of an open peanut challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an forced expiratory volume in 1 second (FEV1) \< 80% of predicted, or FEV1/FVC (forced vital capacity) \< 75%, with or without controller medications
* Subjects unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
* Pregnant or lactating
* Allergy to oat
Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake

The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥21 years
* Diagnosis of T2DM
* Metformin as first line treatment
* HbA1c ≥7
* Calculated HOMA-IR ≥3.0,
* BMI 25-45
* Triglyceride level ≥ 2.26 mmol/L

Exclusion Criteria:

* Age \<21 years of age
* BMI ≤ 25
* Pregnant
* Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
* Subjects treated with Liraglutide (Victoza®).
* Renal, hepatic or cardiac failure.
* Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™
* Subjects diagnosed with Irritable Bowel Syndrome.
* Subjects diagnosed with Ulcerative Colitis or Crohn's disease.
* History of significant gastrointestinal disease.
* Poor venous access.
* Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™
A Study to Test How Well Healthy Men Tolerate BI 765250 When Given as an Infusion Into the Vein or as an Injection Under the Skin

The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 765250.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections Further exclusion criteria apply
Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia

This is a randomized controlled trial comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of motor function in the legs in young children with spastic diplegia.

Children born prematurely are at risk of brain injury that can result in cerebral palsy(CP), most often affecting the legs, called spastic diplegia. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (Botox) in muscles that are abnormally active, and surgery as deformities occur. Active, physical therapy for weak muscles is infrequent, occurring twice a month or less. Yet, recent work with mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young. Building on the success with early, intensive therapy for children with perinatal (around birth) stroke, the investigators will apply intensive therapy for the legs in children with diplegia. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 3 mo. The delay period controls for improvement without treatment. These children will also receive treatment after the delay period. The therapy will be guided by physical therapists, and similar to the project on perinatal stroke. Children who live beyond commuting distance from the centres will form a 3rd group, whose parents will be coached by therapists to train the child at home. This group will show whether parents can be as effective as a therapist. Finally, when all children turn 4 yr old, they will be compared to other 4-yr-old children with the same diagnosis, but no training, to determine if there are long term benefits. The investigators anticipate that like the children with perinatal stroke, early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.

Eligibility Criteria:
Inclusion Criteria:

* children aged 8 mo - 3 yr old
* Evidence of periventricular white matter injury on diagnostic imaging
* clinical evidence of spastic diplegia

Exclusion Criteria:

* born before gestational age of 25 weeks
* birth weight \<1000g (to exclude confounds related to extreme prematurity and low birth weights)
* MRI evidence of diffuse injury to the cerebral or cerebellar cortex
* uncontrolled epilepsy or infantile spasms in the past 6 months (contraindication for TMS)
* cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
* Botulinum toxin (BTX-A) injections in the last 6 months
* Predicted GMFCS 4 or 5