cyrilzakka/clinical-trials huggingface dataset:
Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment

Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.

This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).


Eligibility Criteria:
Inclusion Criteria:

* Active polypoidal choroidal vasculopathy,
* Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
* Age above 45
* No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
* Intravitreal injection of aflibercept is indicated by current clinical recommendations

Exclusion Criteria:

* Simultaneous treatment with another anti-VEGM agent
* Diabetic retinopathy
* Personal history of vitrectomy or uveitis
* Personal history laser photocoagulation and/or verteporphin phototherapy
* Tear in the pigmentary epithelium
* Chorioretinitis scar
* Macular atrophy in the pigmentary epithelium
* Treatment with corticosteroids
* Eye surgery less than 3 months before inclusion
A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy

The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment.

Exercise has been shown to play an important role in reducing many of the side effects associated with chemotherapy treatment. Exercise can help to improve symptoms of fatigue, nausea, muscle weakness, and pain, which in turn can help to improve patients overall quality of life and wellbeing. In addition to this, exercising during chemotherapy can also help to maintain physical fitness and preserve muscle mass, which has been shown to significantly reduce treatment toxicities. Despite these benefits of exercise, performing regular physical activity during chemotherapy poses significant challenges. Patients are faced with a number of physical and logistical barriers during chemotherapy which makes it difficult to engage in regular exercise. In addition to this, exercise programs that are being designed lack flexibility and individualization, and don't account for the unpredictable nature of chemotherapy treatment. It is, therefore, no surprise that patients struggle to meet the exercise recommendations during chemotherapy, and highlights the need for careful consideration when prescribing exercise during this time. In preparation for this study, the research team held a number of workshops which included a mixture of patients and healthcare professionals with the aim of co-designing an exercise intervention for patients during chemotherapy. Including public and patient involvement (PPI) in the design process will help to ensure that the exercise program that is developed is pragmatic and, most importantly, patient-centred.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>18.
* Histological confirmed diagnosis of stage I to IIIc breast, ovarian or colorectal cancer.
* Scheduled to receive chemotherapy ± immunotherapy with curative intent.
* Medical clearance from oncologist to partake in regular exercise in accordance with American College of Sports Medicine (ACSM) preparticipation screening algorithm.
* Ability to provide written informed consent.

Exclusion Criteria:

* Advanced/metastatic disease.
* Scheduled to receive concurrent chemoradiotherapy.
* Scheduled to receive high-dose chemotherapy during hospital admission.
Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

The aim of the study is to compare the safety \& efficacy of sertraline (up to a dose of 200mg/day) \& pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy.

Patients with epilepsy will be treated with either sertraline (up to a dose of 200mg/day) or pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety. Outcome measures will include changes in the anxiety severity scales.

Eligibility Criteria:
Inclusion Criteria:

* GAD-7 total score above 10.
* Have a diagnosis of a Partial Seizure Disorder.
* Have a Hamilton-A total score 20 and above.
* 18-80 years of age.
* Able to read at a fourth grade level.
* If a woman of childbearing age, agrees to use an acceptable means of birth control.

Exclusion Criteria:

* Unable to understand and sign a consent.
* Unable to follow instructions for the study.
* Displaying current suicidal ideation
* Having psychogenic non-epileptic seizures
* Have a history of drug or alcohol abuse.
* Use of any investigational drug within the last 30 days.
* Hypersensitivity reaction or other serious adverse event to PGB in prior trials.
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.


Eligibility Criteria:
Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
* Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis.
* Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing.
* Has measurable disease per RECIST 1.1 guidelines.
* Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx.
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding.
* Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception.

Exclusion Criteria:

* Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.
* Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.

  * Prior systemic therapy completed \>6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.
* Has clinically active central nervous system metastases and/or carcinomatous meningitis.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.
* Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.
Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.

Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).

A voiding cystourethrogram was performed for each child less than 3 years old with a first urinary tract infection. In case of vesico-ureteral reflux, a randomization was done between continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no antibioprophylaxis. Duration of follow up was 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 3 years old
* First proved urinary tract infectionIsolated vesico-ureteral reflux
* Parents have been fully informed and have given written informed consent to participate in the study

Exclusion Criteria:
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults

This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.

This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the sponsorship of the trial was transferred to Biogen along with responsibility for subsequent updates to the record.

Eligibility Criteria:
Inclusion Criteria:

* Has a body-mass Index (BMI) \>/=18.0 and \</=32.0 kg/m2
* Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding
* Has a lifetime history of menopausal hot flashes
* Has a clinically significant medical condition
* Has had a clinically significant illness in the 30 days prior to first study drug administration
* Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
* Has had any vaccinations in the 4 weeks prior to inpatient admission
* Has a lifetime history of diabetes
* Additional criteria may apply
Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

The purpose of this study is to determine whether implanting gold beads extraarticularly in five acupuncture-points around a knee improves pain, stiffness and function in patients with knee osteoarthritis.

Osteoarthritis (OA) is one of the most common diagnoses made in general practice and among the most common causes of disability in older people. Acupuncture is a well-founded supplement or alternative to pharmacological and surgical treatment methods. The improvement is, however, often brief, so to preserve the initial effect the acupuncture has to be repeated at regular intervals.

In veterinarian medicine implantation of gold-beads in acupuncture-points around a joint has been used mostly in dogs for at least 30 years in the treatment of OA. The effect measured on eating pattern, physical activity and signs of pain last for several years. It may be hypothesized that implanting gold in acupuncture points acts as a continuous acupuncture stimulation.

The purpose of this one year randomised, controlled trial of middle-aged and elderly patients is to examine the effect of implanting gold beads extraarticularly in five acupuncture-points around a knee with OA.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Clinically diagnosed and radiologically verified knee osteoarthritis (OA)
* Pain and stiffness derived from OA lasting for more than one year

Exclusion Criteria:

* Previous knee trauma (OA following previous meniscectomy is included)
* Other rheumatologic conditions like rheumatoid arthritis or fibromyalgia
* Pronounced hip OA
* Severe somatic or mental illnesses
* Dementia
* Alcohol or drug abuse
* Pregnancy
* Anticoagulant treatment
* Corticosteroid treatment during the last 3 months
* Allergy to chlorhexidine or local anaesthetics
Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control

Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial with 2 arms, involving 111 patients in total. The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.


Eligibility Criteria:
Inclusion criteria

* Age between 4-16 years.
* Signing of informed consent.
* Refractive error: myopia greater than -1.00 diopters (D).
* Myopia progression of at least -0.50 D in the last 12 months.
* Astigmatism of 2 D or less and anisometropia of 1.50 D or less.
* Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better.

Exclusion criteria

* Children under 4 years old and over 16 years old
* Strabismus and binocular vision anomalies.
* Alterations in eye fundus that the researcher consider necessary the patient exclution.
* Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision
* Amblyopia
* Previous eye surgery
* Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation)
* Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study.
Taste Changes With Bariatric Surgery

It is commonly believed that a link exists between BMI and taste perception. One group of researchers observed that women who are obese experience reduced taste sensitivity when compared to normal-weight controls. Others have compared taste sensitivity between lean and obese subjects and found no significant differences. The inconsistencies in these studies demonstrate how much variation in taste sensitivity is possible when different factors are applied in research. Throughout several studies, one element remains constant - bariatric surgery causes appetite aversions. These changes in appetite and food preference likely have a large influence on the overall magnitude of post-surgical weight loss. Although many studies have investigated the changes in taste preference after bariatric surgery, few, if any, have focused on changes in sweet taste perception.

The overall goal of the present project is to determine how future bariatric surgery will affect the taste for sweet liquids. Taste perception will be assessed before surgery (pre-operative, pre-op) and after bariatric surgery, at approximately 1 month. Taste studies will be conducted with solutions prepared freshly before each test using sucrose dissolved in distilled water. Six concentrations of sucrose (table sugar) will be tasted in random order, with the most concentrated solution being roughly the sweetness of soda. The subject is blinded to the concentrations. It is hypothesized that there will be no significant difference in taste perception when pre-op and post-op values are compared. However, the investigators hypothesize that taste preference will identify solutions with lower concentrations post-op.

Eligibility Criteria:
Inclusion Criteria:

* Women who plan to undergo bariatric surgery.
* Age: 21-70y.
* Non-smokers (at least 3 months post smoking cessation).
* Non-diabetic or prediabetic

Exclusion Criteria:

* Subject on a medication known to affect taste perception: Antibiotics, thyroid medications, psychotropic, neurological, and cardiac medications.
* Inability to understand the test instructions.
* Subject has already undergone bariatric surgery
Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes

This study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. The goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis. There is very little literature concerning this procedure.

Isthmic spondylolisthesis can cause back and leg pain. If pain persists after well conducted medical management, a surgical treatment can be proposed. Even though the goal is consensual, there are plenty of ways to reach vertebral fusion: ALIF, PLIF, TLIF, Posterior fusion only, etc... This study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. The goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis using standard XRays, CT Scan and patient reported outcome measurements. There is very little literature concerning this procedure.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged over 18 years
* With isthmic spondylolisthesis at L4-L5 or L5-S1
* Operated in our center with a double approach: Anterior lumbar interbody fusion then postero-lateral fusion
* Consent for participation

Exclusion Criteria:

* Pseudarthrosis L5-S1
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.


Eligibility Criteria:
Key inclusion criteria:

* Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features
* Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole
* Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline
* Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.

Key exclusion criteria:

* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product
* A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
* Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
* Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
* Thyroid pathology
* Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.
* History of neuroleptic malignant syndrome from antipsychotic agents
* Manic symptoms that investigator considers refractory to treatment
* Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms
* Significant risk of suicide based on history, mental status exam, or investigator judgment.
Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)

To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered as single and multiple oral doses in healthy subjects, and in subjects with T2DM


Eligibility Criteria:
Parts A and Part B of the study (maximum age 45 years):

Inclusion Criteria:

* Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study.
* Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

Part C of the study (maximum age 65 years):

Inclusion criteria:

* Drug naive patients with T2DM or patients who are on metformin-monotherapy (at current dose for ≥ 8 weeks) with inadequately controlled blood glucose levels (HbA1c \>7 %and \<10 %) Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)

Exclusion criteria:

* Poorly controlled diabetes with either new onset or worsening of symptoms of polyuria and polydipsia, weight loss, fatigue, abdominal pain, or other significant signs and symptoms
* Any of the following medical conditions: uncontrolled hypertension, unstable angina pectora, Cushing's syndrome, Addison's disease, uncontrolled hyperthyroidism or hypothyroidism, significant liver disease or renal failure, malignant diseases, or immunodeficiency (e.g., HIV/AIDS or organ-transplant), or history of myocardial infarction, congestive heart failure defined as New York Heart Association (NYHA) stage II and above, significant valvular disease, cardiac arrhythmia, or transient ischemic attack or cerebrovascular accidents (occurred within 6 months prior to entry into the study), or family history of Long QT Syndrome
Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity

The investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in NCGS patients.


Eligibility Criteria:
Inclusion Criteria:

* Non-coeliac gluten sensitivity patients

  * Previous symptoms of IBS fulfilling Rome III criteria that self reportedly improved with a gluten-free diet
  * Symptoms currently well controlled on a gluten-free diet
  * Adherence to the gluten-free diet for at least 6 weeks prior to recruitment
  * Coeliac disease excluded (either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten-containing diet in individuals expressing the HLA-DQ2 or HLA-DQ8 haplotype)
  * IgA anti-tissue-transglutaminase or IgG anti-deaminated gliadin peptide positive
* Body Mass Index (BMI) of 20 - 25 kg/m2
* Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

* Medical

  * Coeliac disease
  * Abdominal or thoracic surgery. Exception: appendectomy
  * Gastrointestinal, endocrine or neurological diseases
  * Cardiovascular, respiratory, renal or urinary diseases
  * Hypertension
  * Food or drug allergies
* Psychiatric disorders

  * Eating disorders
  * Depressive disorders
  * Anxiety disorders
  * Psychotic disorders
* Restraint or emotional eating
* Medication on a regular basis, exception: oral contraception
* History of cannabis use or any other drug of abuse for at least 12 months prior to the study
* Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
* Pregnant or breastfeeding women