cyrilzakka/clinical-trials huggingface dataset:
Study of a Carbohydrate Drink in Adults

The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
* Subject is healthy or has pre-diabetes or type 2 diabetes
* Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
* Subject's BMI is \> 18.5 kg/m2 and ≤ 40.0 kg/m2
* If subject is on a chronic medication, the dosage has been constant
* Subject states willingness to follow protocol

Exclusion Criteria:

* Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control
* Subject has type 1 diabetes
* Subject has a history of diabetic ketoacidosis
* Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics
* Subject has an active malignancy
* Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure
* Subject has end-stage organ failure or is status post organ transplant.
* Subject has a history of renal disease
* Subject has current hepatic disease
* Subject has a history of severe gastroparesis
* Subject has a chronic, contagious, infectious disease
* Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose
* Subject has clotting or bleeding disorders
* Subject is known to be allergic or intolerant to any ingredient found in the study products
* Subject is a participant in another study that has not been approved as a concomitant study
Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).

The target study population of this Phase 1b/3 registrational study is patients with R/R DLBCL who have completed at least 2 (but not more than 4) lines of prior rituximab-containing multi-agent chemotherapy, and/or in whom autologous stem cell transplant (ASCT) has failed, or who are not candidates for ASCT or who are not eligible for intensive chemotherapy. Patients who are ineligible for intensive second line chemotherapy must have received at least one prior rituximab-containing combination chemotherapy regimen. The study will assess the safety, efficacy, pharmacokinetics (PK), immunogenicity of the 3 avelumab-based combination regimens tested, and collect patient reported outcome (PRO) data.

Eligibility Criteria:
Key Inclusion Criteria:

-Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed:

* Diffuse large B-cell lymphoma (DLBCL), Not Otherwise Specified (NOS): Germinal center B-cell type (GCB), Activated B-cell type (ABC)
* High-grade B-cell lymphoma (HGBCL) NOS
* HGBCL with MYC and BCL2 and/or BCL6 rearrangements
* T-cell histocyte-rich large B-cell lymphoma
* EBV+ DLBCL, NOS
* HHV8+ DLBCL, NOS

Relapsed or refractory disease following at least 2 lines (and a maximum of 4 lines) of prior rituximab containing multi-agent chemotherapy which may include an autologous stem cell transplantation unless patients are not considered suitable for intensive second-line chemotherapy or autologous stem cell transplantation. Patients who are ineligible for intensive second line chemotherapy,must have received at least one prior rituximab-containing combination chemotherapy regimen. Patients who are ineligible for intensive second line chemotherapy, must have received at least one prior rituximab-containing combination chemotherapy regimen.

* Baseline measurable disease with at least 1 bi dimensional lesion with longest diameter (LDi) \>1.5cm on CT scan which is FDG avid on PET scan.
* A biopsy (archived or Screening/recent) will be collected at Screening.
* At least 18years of age (or ≥20 years in Japan).
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

Key Exclusion Criteria:

* Active central nervous system (CNS) lymphoma.
* Prior organ transplantation including prior allogeneic SCT.
* Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody, or drug specifically targeting T cell co stimulatory or immune checkpoint pathways).
Zonisamide Versus Propranolol in Migraine

Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency

Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 100mg zonisamide daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive propranolol 160 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Eligibility Criteria:
Inclusion Criteria:

* Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition,
* age from 10 to 55 years

Exclusion Criteria:

Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.

patients with malignancy, collagen, liver, and renal diseases. patients with cardiovascular diseases like hypertension and diabetes patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study patients with bronchial asthma, chronic obstructive pulmonary disease
Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women requesting copper IUD insertion

Exclusion Criteria:

* pregnancy, Parous women, contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, untreated active cervicitis or vaginitis, undiagnosed abnormal uterine bleeding
The Plasma Diafiltration Therapy of Hepatic Failure

At present, there is no comparative study between the simple plasma exchange and plasma diafiltration (PDF), and no further exploration of optimal plasma dose in PDF treatment. Therefore, this prospective randomized cohort study aims to compare the safety and effectiveness of the tree groups（simple plasma exchange group, conventional PDF treatment group, less plasma PDF treatment group）by collecting SOFA score, 3-month survival rate, MELD score, and the times of artificial liver treatment , blood cell variables, cytokines(e.g. TNFα ), pre- and post-treatment plasma ammonia levels. Thus, it is to provide a safer and more effective artificial liver treatment with less plasma dose.


Eligibility Criteria:
Inclusion Criteria:

* hepatic failure on Medium period
* Model for End-Stage Liver Disease (MELD) \<30 and \>20
* age \> 18 years and \<70years
* Written informed consent

Exclusion Criteria:

* Active bleeding or disseminated intravascular coagulation
* allergic to blood products or drugs such as plasma, heparin and protamine
* hemodynamic instability
* cardiovascular and cerebrovascular accidental infarction instability Period
* extravascular hemolysis
* severe sepsis
* Tumor on ultrasonography, CT or MRI examination
* Pregnant or lactating women
Effects of Travatan Z and Xalatan on Ocular Surface Health

The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
* Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
* IOP controllable and stable on the study medication alone (both eyes).
* Believed to have ocular surface disease (OSD).
* Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
* Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
* Current use of punctual plugs.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* Suspected or diagnosed with Sjogrens's syndrome.
* Current use of any brand of artificial tears containing BAK.
* Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
* Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
* Current use of contact lenses within 30 days of Visit 1.
* Participation in any other investigational study within 30 days prior to Visit 1.
* Other protocol-defined exclusion criteria may apply.
Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain

This study is a prospective, interventional, open-label, single arm, non-randomized trial treating 30 patients with peripheral or mixed neuropathic corneal pain at their baseline exam and following 45 days and 90 days of daily use with the TrueTear™ ITN device.

The investigators hypothesize that the stimulation through the ethmoidal nerve in the nasal cavity may have an inhibitory effect on the primary TG interneurons and block the ocular pain signaling to the brain.

The investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims:

Specific Aims:

1. To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal pain patients.
2. To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use.
3. To assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>22
2. Ability to consent to study.
3. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
4. Positive in vivo confocal microscopy (IVCM) findings for NCP such as presence of microneuromas and decreased nerve density.
5. Fifty percent or more relief of pain or discomfort after instillation of Proparacaine eye drops as measured by the Visual Analogue Scale (VAS).

Exclusion Criteria:

1. Clinically significant acute ocular surface diseases, such as active infectious keratitis or recent ocular surgery in the past 3 months.
2. Chronic or recurrent epistaxis, coagulation disorders.
3. Nasal or sinus surgery or significant trauma to the nose.
4. Severe nasal airway obstruction or vascularized nasal polyps.
5. Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
6. Chronic or recurrent nosebleeds
7. Bleeding disorder
8. Known hypersensitivity (allergy) to the hydrogel material
9. Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)

The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) is safe for pregnant participants and their offspring.

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Participants who received one dose of corifollitropin alfa in Trial 38833;
* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
* Able and willing to give written informed consent.

Exclusion Criteria:

* None
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain

* The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients with moderate to severe chronic low back pain.
* The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life, to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
* Patients with pain categorized as Class 1 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of \>17 at baseline to qualify. Patients with pain categorized as Class 2 or Class 3 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of at least 10 at baseline to qualify.
* Patients must have required daily analgesics for the treatment of low back pain for at least 3 months prior dosing.

Main Exclusion Criteria:

* Patients may not have persistent moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity).
* Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline.
* Patients may not have an unstable medical condition.
Gene-environment Interactions in Families With Adolescents (Gen-omgevingsinteracties in Gezinnen Met Adolescenten)

English:

The main purpose of this study is to investigate the developmental trajectories of parents and adolescents in the Flemish region of Belgium. The investigators will focus on the role of genetic factors, environmental factors (e.g. parental rearing styles), and the interaction between these factors. Specifically, it will be investigated were difficulties or strengths in the development of adolescents can be attributed to. How an individual's genetic characteristics and his/her family environment can interact, will also be monitored. This study is closely related to the Leuvense Adoption Study (http://leuvenseadoptiestudie.be/). Just like this research, the investigators will take child and parent factors in account, as well as their interaction. The investigators will not only focus on vulnerability, but also on protective factors that can give resilience to both parents and children. The theoretical framework of this study is twofold. (1) In the development of children, genes and environment are interwoven in a dynamical relation. Neither genes or environment alone can explain how a child will develop over time. (2) The relation between genetic and environmental factors can be expressed in different ways. On the one hand, a certain genetic contribution can impact the way parents will uphold a certain parental rearing style. On the other hand, having certain genetic characteristics will have consequences for how adolescents will react to their environment. For example, a certain parental rearing style will strengthen some adolescents resilience, but for other adolescents this could equally lead to a more maladaptive development. Thus, depending on his or her genetic endowment, a child will develop differently given a certain family environment.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents adopted before the age of one and currently 12 to 18 years old (from international adoption) and their adoptive parents
* Matched community sample of adolescents between the age of 12 and 18 years old and their biological related parents

Exclusion Criteria:

* Major medical or psychiatric disease
Combined Neuromuscular Electrical Stimulation for Quadriceps and Triceps During Pulmonary Rehabilitation in COPD

Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.

Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.

Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.

A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Patient with COPD stages 2 to 4 (A to D) admitted to the Pulmonary Rehabilitation Department of the "Centre Hospitalier des Pays de Morlaix" or the "CHRU of Brest".
* Patient aged 18 years or older.
* Patient able to consent and having signed a consent form.

Exclusion Criteria:

* Patient with a history of pneumonectomy, lobectomy dated less than 6 months old
* Patient with an inability to complete a respiratory rehabilitation program in its entirety
* Patient under guardianship or curatorship
* Person equipped with electronic devices such as pacemakers and intracardiac defibrillators.
* Skin lesions and infectious foci on the area where the electrodes.
* Pregnant or breastfeeding women
Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events

This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* Female or male aged 18 years and over
* Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture.

Exclusion Criteria:

* History of heparin-induced thrombocytopenia
* Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency.
* Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment.
Genetics of Periodontal Diseases in European Caucasians

(A retrospective case control study to validate the association between Interleukin-1 gene variations and adult chronic periodontal disease in European Caucasians)


Eligibility Criteria:
Inclusion Criteria:

* Ethnicity: Dutch or German Caucasian

Exclusion Criteria:

* None (however, diabetics were excluded during original patient recruitment at several clinical sites).