cyrilzakka/clinical-trials huggingface dataset:
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.

Eligibility Criteria:
Inclusion / Exclusion Criteria:

* Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
* Screening testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/mL.
* Eastern Cooperative Oncology Group (ECOG) score of ≤2.
* Screening prostate-specific antigen (PSA) level ≥ ng/mL.
QOL Assessment in Cancer Survivors Integrated Into Routine Clinical Care

This observational cohort study of patients who received cancer treatment (of any modality) in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are evaluated via telephone or in person or both. Patients with high-risk for unmet needs or distress as determined by the FACT-GP are referred to an in-person Multidisciplinary Cancer Survivorship Clinic. This is considered standard of care at the investigator's institution and is part of the continuous clinical quality improvement program within the Geisinger Cancer Institute.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignancy in the last 18 months, treated with curative intent

Exclusion Criteria:

* Patients treated with palliative intent, metastatic disease at the time of diagnosis
Obese Pregnant Women: Optimizing Fetal Ultrasound

This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.

Ultrasound examination for fetal anomaly is especially challenging in obese gravida. The foetus is more likely to have congenital anomalies and imaging in these patients is technically more difficult.

The investigators hypotheses that an earlier ultrasound with alternative technics will improve the quality and thereby improve the identification of anomalies. By using transvaginal ultrasound and abdominal ultrasound at the window just above the symphysis, were the subcutaneous fat is known to be thinner, the investigators hope to achieve a better overview. This will be done by evaluating fetal ultrasound at three different gestational ages (GA); GA 13, 15 and 21 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* BMI ≥ 30 Kg/m2
* BMI: 18,5-25 Kg/m2
* Understand and speak Danish and thereby be able to give confirmed consent.

Exclusion Criteria:

* Multiple gestations
* Overweight (BMI: 25-29,9 Kg/m2)
* Alcohol or drug abuse
* Chronically diseases before pregnancy as diabetes, hypertension, or thyroid diseases
* Gastric bypass or other obesity related surgery
Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

We will evaluate an e_Prescription intervention can be integrated into an electronic screening program, which together exploit: (i) reach - the adult population has 100% mobile phone ownership and 92% internet national coverage; and (ii) behavioral change - the intervention can teach verbally and visually, thus bypassing literacy challenges, to allow simple, low-cost, repetition messaging for habit reinforcement. Uptake of the program through the various stages will be evaluated in \~2000 adults of a large representative suburban district of Karachi: As well as before-and-after physiological measures, including blood pressure (BP) and blood glucose, a random sample of 30-40 participants will be invited for interview to assess success and failure of the program. This is a pragmatic feasibility intervention implementation study.

The goal of this pilot study is to demonstrate feasibility of a scalable , population-wide, approach to early detection and management of people at high-risk of CVD using electronic screening, referral, treatment and lifestyle modification based on health theory and considerable background research for local applicability.

It is a mixed method, feasibility study based in Malir District of Karachi, the largest city in Pakistan, to demonstrate uptake, participation and response of our mHealth intervention.

Eligibility Criteria:
Inclusion Criteria:

* All adult (\>18 years) residents of Malir district
* Own a mobile phone
* Provide written informed consent are eligible to participate

Exclusion Criteria:

* Not permanent residents of Malir district.
* A person who is decision impaired due to stroke, or aphasia or dementia .
* Serious cognitive deficits that impair the visualization or understanding of SMS, IVR and e_prescription messages
MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel

This research is collecting data to determine the benefits of a web-based wellness program designed to improve the health and well-being of individuals in the workplace. Participants will be invited to participate in a web-based Healthy Weight Program. The program is designed to optimize health and wellbeing by promoting physical activity and healthy eating.


Eligibility Criteria:
Inclusion Criteria:

* A military member of the Canadian Forces Base in Halifax

Exclusion Criteria:

-
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels

This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair


Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients, body weight between 40-150 kg aged 18-65 years (inclusive)
* Patients diagnosed with asthma with Forced Expiratory Volume (FEV1) ≥65% of the predicted normal value for the patient
* Positive skin prick test to a specific allergen
* Patients had to demonstrate a Provocative Dose 20% FEV1 decline (PD20) response to an aeroallergen in the graded allergen bronchoprovocation testing (ABP) at screening

Exclusion Criteria:

* Current active smokers
* Patients who have been hospitalized or had emergency treatment for an asthma attack in the 12 months prior to study start
* History of bleeding disorders
* History of drug allergy
* Pregnant women or nursing mothers
* Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
* Sexually active males who have not been sterilized and are not using a condom
* History of immunocompromise, including a positive HIV
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within 12 months of study start

Other protocol-defined inclusion/exclusion criteria may apply
Colonoscope Passive Bending Function

A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.

Results from the first prototype evaluation has been published.Modifications are presently evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for routine outpatients colonoscopy

Exclusion Criteria:

* Pregnant women
* Age below 18 years
Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for CD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6. Assessments include HBI score, SES-CD score, and serum CRP levels.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 and \< 65 years at the time of screening
2. Diagnosis of ileo-colonic or colonic CD for \> 3 months but \< 5 years prior to screening as determined by the investigators
3. Those with mild to moderate CD
4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate for \> 3 months
5. Where applicable, those who are taking the following medications must be at a stable dose defined as:

   i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine, 6-MP, and methotrexate must be at a stable dose for \> 8 weeks
6. ability to provide informed consent
7. evidence of active colonic inflammation

Exclusion Criteria:

1. Those with prior ileo-cecal resection
2. Those who are pregnancy or plan to be pregnant during the trial
3. Those who are breastfeeding or plan to breast feed during the trial
4. Those who are on or have previously failed a biological agent
5. Those who have active perianal disease as determined by investigators
6. Those with an active infection requiring antibiotic therapy
7. Those with positive stool cultures for known pathogens such as E coli, Salmonella, Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of enrollment
8. Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
9. Those with allergy to ciprofloxacin and metronidazole
Effect of Self-administered tDCS in Patients With MDD

In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.

Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
* Greater than 22 points of Montgomery-Asberg Depression Rating Scale
* Aged 19 to 65.
* Has provided informed consent
* Has received Escitalopram as a combined antidepressant during the study period

Exclusion Criteria:

* Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
* History of suicidal attempt in the last 6 months
* Diagnosed with bipolar or psychotic major depressive disorder
* Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
* Has hypersensitivity to Escitalopram ingredients
* A score of 5 or greater for the question #10 in MADRS
* Diagnosed with closed angle glaucoma or has a history of glaucoma.
* History of participation in other clinical trials within 30days.
* A major and/or unstable medical or neurologic illness
* Currently taking substances pimozide
* Pregnant or has a positive pregnancy serum test.
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
* Must self-identify as either Black or African American in race in the open label addenda.
* Have severe or very severe AA, as determined by all of the following:

  * Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT Alopecia Areata Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline.
  * No spontaneous improvement over the past 6 months.
  * Current episode of severe or very severe AA of less than 8 years.
* Male or nonpregnant, nonbreastfeeding female participants.

Exclusion Criteria:

* Primarily "diffuse" type of AA.
* Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
* Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
Testing a Positive Psychology-based Intervention for Couples Coping With Stroke

This study aims to pilot test an 8-week, self-administered dyadic (couples-based) positive psychology intervention for couples coping with stroke using a randomized, waitlist control design. Mood and well-being will be assessed pre- and post-intervention, and at 3-month follow-up. It is expected that both partners will demonstrate improvement in mood and well-being.

Stroke survivors and spousal caregivers face significant challenges, yet interventions to support couples after stroke are largely lacking. Depressive symptoms post-stroke occur in 30-50% of survivors and partner caregivers, and have significant consequences on function and quality of life. Further, mood and psychosocial well-being are reciprocal in couples, meaning if one partner is depressed, the other is more likely to be depressed. Sustaining well-being in both partners is important for continued engagement in rehabilitation and re-integration into the community, yet existing interventions are aimed at the individual rather than the couple. This study will address this gap by testing an innovative dyadic (couples-based) intervention using a new approach based on positive psychology that focuses on the strengths in the relationship in order to foster resilience in the couple. Using a randomized waitlist control design, this pilot study aims to determine whether an 8-week dyadic positive psychology-based intervention (PPI) can improve mood and subjective well-being as assessed by established outcome measures in 24 couples coping with stroke. The intervention consists of self-administered PPI activities, such as expressing gratitude and practicing acts of kindness, which participants complete individually and as a couple. Two potential pathways will be explored for the PPI: (a) enhanced quality of interactions as couples deal with daily life demands and (b) improvements in mood that are "contagious" among couples. If found effective, couples with greater well-being may be better emotionally equipped to cope with the sequelae of stroke by reducing stress and depressive symptoms, and increasing participation in meaningful activities and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Couples consist of one partner who had an ischemic or hemorrhagic stroke \>3 months ago and a cohabiting partner (\> 1 year) who self-identifies as the caregiver and is willing to enroll in the study;
* Either one or both partner(s) report depressive symptoms as assessed by the PROMIS-D (no formal diagnosis is required).

Exclusion Criteria:

* the caregiver has had a stroke or other major neurological condition;
* either partner is unable to understand the printed English instructions;
* either partner scores \<19 (the established cut-off for mild cognitive impairment) on the Montreal Cognitive Assessment (MoCA), a validated screening instrument for cognitive performance.
Compassionate Use: Progressive Metastatic Castrate Resistant Prostate Cancer; Monotherapy Treatment With Trametinib

The dosage of trametinib for oral administration is 2mg once daily. The patient is instructed to take the trametinib oncedaily dose at approximately the same time each day, by mouth with approximately 200 mL (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal.

The dosage of trametinib for oral administration is 2mg once daily. The patient is instructed to take the trametinib once daily dose at approximately the same time each day, by mouth with approximately 200 mL (almost 1 cup) of water on an empty stomach, either 1 hour before or 2 hours after a meal.

The patient will be provided with complete dosing instructions from his treating physician. If the subject is instructed that if he vomits after taking either of the medications provided under this program, he should not retake the dose. The patient should take the next dose as originally scheduled. If a dose is missed, the patient should not double the next regularly scheduled dose. However, the patient can take the missed dose immediately if the next scheduled dose is at least 12 hours later. If the next scheduled dose is due in less than 12 hours, the patient is instructed to skip the dose and resume dosing the next day at the regular time. Then to take the next dose at the usual time the subject is scheduled to take it. It is not known for how long the subject will remain in the program because each patient may respond differently to the treatment. The length of time the patient will take trametinib therapy will depend on his cancer status and how well he tolerates the drugs. If he experiences severe side effects, he is instructed to call his treating physician immediately. The treating physician may advise him stop compassionate used of trametinib or may advise him to lower the dose. Trametinib may also be stopped completely at his Treating Physician's discretion. The treating physician will use his/her clinical expertise considering the intensity of the adverse effect and/or the results of your laboratory tests to make his/her decision. The Treating Physician may consult with the Novartis Country Pharma Organization Medical Advisor/Director about dose interruptions or modifications.

Eligibility Criteria:
Inclusion Criteria:

* Progressive Metastatic Castrate Resistant Prostate Cancer

Exclusion Criteria:

* Absence of Progressive Metastatic Castrate Resistant Prostate Cancer
Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System

Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI examinations. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement , which demonstrates the need of practical, safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing system is developed by Sorin Group for safe use in the MRI environment. The new pacing system is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group Reply MR-conditional pacing system.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for dual-chamber pacemaker primo-implantation
* Patients who have indication for implantation of a dual-chamber pacemaker according to the American College of Cardiology and the American Heart Association
* Patients who are able and willing to undergo elective MRI scanning
* Patients who are scheduled for implant of a Reply DR pacemaker and Filtrea lead(s) only
* Patients who provided signed and dated informed consent

Exclusion Criteria:

* Non MR-compatible device or material implant
* Chronic atrial fibrillation (for atrial lead evaluation)
* Incessant ventricular tachyarrhythmia (for ventricular lead evaluation)
* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for scheduled follow-ups at the implanting centre
* Already included in another clinical study that could affect the results of this study
* Inability or refusal to provide informed consent
* Patient is minor (less than 18-year old)
* Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment);
* Patient has life expectancy of less than 1 year
* Patient is forfeiture of freedom or under guardianship
* Any patient to whom a contra-indication from device and lead labeling applies
Atrial Fibrillation Prior and Post Elective Cardioversion

Cardioversion from atrial fibrillation (AF) to sinus rhythm (SR) is performed primarily to improve patient symptoms. However, due to the intermittent nature of AF, patients may have converted to SR prior to elective cardioversion and the recurrence rate of AF after cardioversion can be high. The aims of this study are to assess the rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion, as well as the rate of early recurrence of AF after elective cardioversion.


Eligibility Criteria:
Inclusion Criteria:

* Planned elective cardioversion of AF
* Informed written consent for participation

Exclusion Criteria:

* Lack of ability to cooperate
* Pacemaker/CRT device
* No smart phone
Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Eligibility Criteria:
Inclusion Criteria: Subjects MUST:

1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
2. Be able and willing to follow all instructions and attend all study visits;
3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
4. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
6. Be presbyopic as determined at Visit 2 baseline

Exclusion Criteria: Subjects must NOT:

1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
3. Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
5. Have clinically significant abnormal lens findings including early lens changes during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;