cyrilzakka/clinical-trials huggingface dataset:
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)

This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
* Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
* Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
* Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
* Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
* Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
* Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
* Able to refrigerate study drug at home.

Exclusion Criteria:

* Mean IOP \>36 mmHg in either eye at screening
* Unable to use study medication in the affected eye(s)
* History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
* History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
* Significant visual field loss or evidence of progressive visual loss within the last year
* Intraocular surgery in either eye in the last 4 months
* Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
* Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
* Previously used tafluprost
* History of cardiovascular disorder within 6 months of screening
* History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.
Implementation of the Symptom Navi© Program

The Symptom Navi© Program is a program to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units.The current study aims to pilot test the implementation of the Symptom Navi© Program under real-life conditions by evaluating procedures, testing preliminary effectiveness and assessing potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods.

Patients treated in cancer outpatient settings in Switzerland have high unmet care needs, especially in the domain of self-management of symptoms. The Symptom Navi© Program was developed to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units. The acceptability and feasibility of the Symptom Navi© Program was supported by a qualitative study with 10 cancer patients who received semi-structured patient consultations and subsequently used the Symptom Navi© Flyers at home.

The overall objective of the current study is to pilot test the implementation of the Symptom Navi© Program under real-life conditions. The aims are to evaluate procedures, to test preliminary effectiveness and to assess potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods. The unit of randomization are the participating cancer outpatient centres with each centre representing a cluster. Intervention cluster will provide the Symptom Navi© Program, control clusters will provide usual care for symptom-management.

Eligibility Criteria:
Inclusion Criteria for patients:

* age ≥ 18 years
* newly diagnosed with cancer within 15 weeks prior to informed consent signature
* planned to receive first cycle of their first-line pharmacological anti-cancer treatment in an outpatient centre (intravenous, oral or subcutaneous)
* signed informed consent

Exclusion Criteria for patients:

* not sufficiently literate in German language to understand written information or follow an interview
* recurrence of cancer disease
* cared by a palliative care team
* being treated solely with surgical or radiation therapy
Ultrasound-Guided TAP Block and Spinal Morphine for Pain Relief After Caesarean Section

This interventional double-blind randomized controlled study was carried out on 60 cases underwent elective caesarean section delivery, they were divided into 2 groups; patients were randomly allocated into two equal groups; Group M: received intrathecal 150 microgram morphine in a 0.5 ml volume, mixed with 10 mg of hyperbaric bupivacaine 0.5 % in a 2 ml volume (total volume 2.5 ml). Group B: received intrathecal 10 mg hyperbaric bupivacaine 0.5% 2ml volume + 0.5 saline (Total volume 3ml) and at the end of surgery patient received bilateral TAP block with 20 ml volume of 0.25% bupivacaine on each side.


Eligibility Criteria:
Inclusion Criteria:

* pregnant females scheduled for elective cesarean section

Exclusion Criteria:

* Patient refusal Patients with known allergies or with past history of allergy to local anesthesia Patients having an infection at the site of injection either in the back or in the abdominal region, Patients with coagulopathy or on systemic anticoagulation, Chronic opioid abuse, significant neurological, psychiatric or neuromuscular disease, Drug abuse and alcoholism, Obesity (BMI 30 and higher), Cardiovascular disease and Endocrine disorders.
Improved Induction and Maintenance Immunosuppression in Kidney Transplantation

This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creating 4 study arms; the other half receive the standard treatment. The two potential improvements are:

1. Administering the immunosuppression induction agent rATG ("rabbit anti-thymocyte globulin") in a single dose at the time of transplantation, instead of in the usual series of 4 smaller doses over 6 days.
2. After 6 months, modifying the maintenance immunosuppression used to prevent rejection by replacing the drug tacrolimus with mycophenolate mofetil (MMF).

The two interventions, spaced sequentially six months apart, enable independent analysis of the two treatments so long as it can be shown that there is no synergistic interaction between them.

The two treatment innovations in this study of immunosuppression in kidney transplantation are aimed at making the transplanted kidney function sooner and last longer than is usual with standard immunosuppression regimens, but without increasing the likelihood of rejection.

The first innovation, delivering the induction agent rATG in a single large dose rather than as a series of smaller doses over 6-8 days, is expected to produce better graft function right away, possibly by reducing some of the injury to the kidney that accompanies the restoration of blood flow during transplantation ("reperfusion injury"). Some evidence has been developed by investigators elsewhere to suggest this will happen.

The second innovation, replacing tacrolimus with MMF after 6 months, is intended to eliminate a well-established major cause of ongoing toxic damage to the kidney. While tacrolimus does a good job of preventing rejection, the cost in continuing toxic injury to the kidney is high, leading inevitably to eventual graft failure, the inability of the transplanted kidney to continue filtering the blood and making adequate volumes of high-quality urine.

Eligibility Criteria:
Inclusion Criteria:

* Primary renal transplant recipient for end-stage renal disease

Exclusion Criteria:

* Recipient age \< 18 years or \> 65 years
* Previous history of CMV disease
* Hepatitis B and C recipients
* Primary disease states that require steroids for immunosuppression
* Re-transplant with immunological cause of renal or pancreas loss
* Non heart beating donors
* Recipient of pediatric en bloc kidneys
* Recipient with a Panel Reactive Antibody (PRA) score \>75%
* Patients who have received 3 or more prior transplants, excluding pancreas
* Patients who are past recipients of other solid organ transplants
* Previous history of BK virus
* Previous treatment with Thymoglobulin
* Allergy to rabbits
* Simultaneous Kidney/Pancreas transplantation
Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer

Head and neck cancers are a source of complications and after-effects related to the disease and treatment. These cancers and their treatment alter the quality of life of patients and generate pain with physical and psychological components. Chronic pain affects 36% of patients at 6 months and 30% after this period. These pains are responsible for the consumption of level II and III analgesics in 53% of these patients. At the same time, after the end of treatment, nearly a quarter of patients continued to smoke and half still consumed alcohol at least twice a week.

The hypothesis of this research is to investigate the correlation between pain and the continuation of addictions, the occurrence of depressive states, asthenia and the alteration of the patients' global quality of life.

The investigators propose a two-center prospective cohort study to evaluate this hypothesis at 6 months after radiotherapy treatment.

This study is planned to include 120 patients with a first head and neck cancer whit radiotherapy as part of their treatment sequence. The expected duration of inclusion is 18 months.

The identification of factors affecting survival, quality of life and patient compliance is essential to determine appropriate management, particularly by creating appropriate therapeutic education programs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a first Head and neck cancer whose therapeutic sequence involves radiotherapy
* Patient over 18 years of age
* Having given written consent
* patient not previously treated with radiotherapy
* Life expectancy \> 3 months
* World Health Organization (WHO) score \< 3
* Histologically proven Head and Neck cancer
* Stable patient, with no signs of recurrence or other progressive neoplasia at the time of the examination
* Patient treated with radiotherapy
* Patient fluent in French

Exclusion Criteria:

* Non-consenting patient
* History of malignancy, other than treated and cured basal cell or cervical cancer
* Patient who has had a salvage surgery other than lymph node removal
* Patient with evidence of recurrence or other progressive neoplasia at the time of examination
* Patient who has had previous mutilating surgery (causing sequelae of swallowing and eating)
* Uncontrolled infectious pathology
* Patient under 18 years of age
* Patient who is not fluent in French
* Patient with a psychiatric pathology that could disrupt the study or prevent the interpretation of the results.
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101

The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 15 subjects in the planned study.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 30.0 kg/m2
* Right-handed only
* Must agree to use effective methods of contraception, if applicable
* Able to swallow multiple capsules
* Able to provide written, personally signed and dated Informed Consent Form

Key Exclusion Criteria:

* Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
* Any clinically significant abnormalities in vital signs, ECGs, physical examinations, or laboratory evaluations
* Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study
* No prescription or over-the-counter (OTC) medications (including multivitamins, herbal or homeopathic preparations 14 days or if applicable/available, 5 half-lives prior to dosing to study end
* Any history of severe head trauma
* No smoking 60 days prior to dosing to study end
Electronic Cigarette Use in Young Adult Men and Women

This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/combustible tobacco product dual users (15 males/15 females) will use smartphone-based ecological momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco product behaviors during a 1-week cigarette/e-cigarette dual use period .(1) Participants will respond to daily random prompts assessing in-the-moment use of e-cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal) and contextual factors (location, activity, social cues) associated with each episode of use. Participants will also complete daily electronic diaries to document e-cigarette use episodes/day, and satisfaction with the e-cigarette experience during the study.


Eligibility Criteria:
Inclusion Criteria:

1. be 18 through 29 years of age;
2. Smoke cigarettes;
3. have experience with e-cigarette use;
4. fluent in English;
5. have a functioning cell phone for personal use ;
6. have access to wireless networks at least once daily;
7. have self-reported good health.

Exclusion Criteria.

1. report serious medical illness;
2. are women who are currently/planning to be pregnant or breastfeeding.
Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning

Non-invasive brain stimulation (NIBS) is a safe, painless way to improve brain function. It is used for many conditions, including to help children with disabilities. However, it can be challenging to apply NIBS in very young children and infants. A new, simple form of NIBS called transcranial static magnetic field stimulation (tSMS) is a promising tool for early brain stimulation. tSMS in adults has been shown to be safe, tolerable and have the desired effects on brain activity when applied to the motor cortex of the brain. However, how tSMS affects on motor function is not understood. This research will use tSMS to target the motor cortex which is responsible for voluntary movement. The study will determine if tSMS can improve motor learning in healthy children. It is hypothesized that application of tSMS on the right motor cortex will decrease excitability of the motor cortex and will lead to improved motor learning in the right hand. tSMS has the potential to become a safe, inexpensive, home-based way to enhance personalized rehabilitation for disabled children.


Eligibility Criteria:
Inclusion Criteria:

1. informed consent/assent
2. age between 8 and 18 years
3. right-handedness
4. normal development
5. absence of neuropsychiatric diagnoses or medications

Exclusion Criteria:

1. diagnosis of a neurological, psychiatric or developmental disorder
2. metal in mouth, implanted pacemakers, or other contraindications for brain stimulation
3. confirmed or potential pregnancy
Alkali Therapy in Chronic Kidney Disease

Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.


Eligibility Criteria:
Inclusion Criteria:

* Estimate GFR \<= 45 and \>15 ml/min/1.73m2
* Age \>18

Exclusion Criteria:

* Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* bicarbonate level \<20 or \>25 mEq/L
* New York Heart Association Class III or IV heart failure
* Systolic blood pressure \>180 mmHg
* Initiation of ESRD treatment planned within 6 months
* Kidney transplantation
* Treatment with immunosuppressives within the last 3 months
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women

Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not been determined. The primary purpose of this study is to examine whether the pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied. This study will be conducted in healthy women since HIV may change the pharmacokinetics of anti-HIV drugs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, HIV negative, nonsmoking females between 21 and 40 years of age.
* Subjects must be within 20% of their ideal body weight and have a regular menstrual cycle, defined as at least 10 cycles per year occurring approximately every 28 ± 4 days and cycle length varying by not more than 7 days.
* Subjects must be willing and able to provide written informed consent.
* Subjects cannot be breast feeding, pregnant or be taking hormonal contraception within 3 months prior to study enrollment. However, they must agree to use an effective non-hormonal method of contraception during the study.

Exclusion Criteria:

* Subjects receiving prescription or over-the-counter products which may interact with the study medication will be excluded from the study.
* Subjects with a Grade 3 or higher laboratory liver, renal or hematology abnormality as specified below in accordance with the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 1.0, Dec 2004, will be excluded.
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 68 subjects are eligible for injection.

This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment T-cell repertoire analysis and by fluorescent activated cell sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Male or female 18 years of age or older
* Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the previous 120 days.
* No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
* Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Positive urine pregnancy test for women of childbearing potential
* Being pregnant or attempting to be pregnant with the period of study participation
* Women who are breast feeding or plan to breast feed within the period of study participation
* Patients who are allergic to Candin®
* If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study
Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia

The purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML).

Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed or relapsed, de novo or secondary AML
2. First induction chemotherapy cycle
3. Expected neutropenic phase of a minimum duration of 10 days
4. Age \>= 18 years
5. Legally signed consent form

Exclusion Criteria:

1. Known proven, probable or possible invasive fungal infection at randomization or in patient history
2. Computed tomography (CT) with any signs of a fungal infection according to the European Organisation for the Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
3. Any current fever unless explained by non-infectious causes
4. Antibacterial prophylaxis other than TMP/SMX
5. Liver function test \[LFT\] (AST/ALT/bilirubin) more than 3x the upper normal limit
6. Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:

   * Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine);
   * Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulfonylureas, ergot alkaloids, sirolimus, vinca alkaloids).
7. Subjects who have received the following drugs within 14 days prior to randomization: potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates)
8. Concomitant therapy with absorbable antifungals
9. Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
10. Known hypersensitivity or other contraindication to voriconazole
11. Patient is unwilling or unable to comply with the protocol.
12. Diseases or disabilities preventing the patient from participating in the trial
13. Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug