cyrilzakka/clinical-trials huggingface dataset:
Open-Label Rollover Study of PBI 4050 in Subjects With Alström Syndrome

Phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and tolerability of PBI-4050 in subjects with Alström Syndrome who have completed a preceding ProMetic-sponsored Alström Syndrome study with PBI-4050.

This is a Phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and tolerability of PBI-4050 in subjects with Alström Syndrome who have completed the end-of-treatment (EoT) visit in a preceding ProMetic-sponsored Alström Syndrome study with PBI-4050. This study will also evaluate the efficacy and pharmacological effects of PBI 4050 in this multi faceted disorder. Approximately 20 to 30 subjects will be enrolled to receive 800 mg PBI-4050 once daily for 96 weeks or until product licensing or study termination by the Sponsor, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed a preceding ProMetic-sponsored Alström syndrome study with PBI-4050.
* Subject has signed informed consent
* Subject has a documented diagnosis of Alström syndrome
* Subject receiving antidiabetic medications is able and willing to self-monitor blood glucose levels
* Subject must be willing to forego other forms of experimental drug treatment during the study.
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use adequate birth control from screening throughout the study and for 30 days after the last Investigational Medicinal Product (IMP) administration
* If a male subject has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last IMP administration.

Exclusion Criteria:

* Subject discontinued PBI-4050 for safety reasons from any preceding ProMetic-sponsored Alström syndrome study with PBI-4050
* Subject has had a documented episode of severe hypoglycaemia within 12 months before screening and investigator judges that the subject is unable to adequately monitor their glucose levels.
* Subject has uncontrolled hypertension with BP \> 170/100 mmHg as determined at screening.
* Woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study as determined at screening
* Subject has any condition that, in the investigator's opinion, is likely to interfere with study conduct and compliance
* Subject has a history of an allergic reaction to PBI-4050 or any of its excipients.
Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome

Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.


Eligibility Criteria:
Inclusion Criteria:

* active smokers presenting to hospital with an acute coronary syndrome

Exclusion Criteria:

* patients with an acute coronary syndrome who are not active smokers
Duobrii in Combination With Biologics

12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks

A single center, pilot study of 25 subjects to assess 12 weeks DUOBRII to patients with 2%-10% body surface area who are receiving biologic therapy for at least 24 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type
3. Psoriasis affecting 2%-10% BSA
4. Patient is being treated with biologic therapy for a minimum of 24 weeks
5. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

1. Psoriasis affecting ˂2% or \>10% BSA
2. Patient not receiving a biologic agent, or receiving biologic agent \<24weeks
3. Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.
4. Has previously used DUOBRII
A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma

This is a continued access protocol to provide subjects who have completed Genentech, Inc. Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1 with continued Xolair treatment. Subject eligibility will be based on disease severity and asthma deterioration upon withdrawal of Xolair treatment. Subjects whose last Xolair dose was \<9 months prior to screening visit will continue with the same Xolair dosing regimen that they received in the previous Genentech or Novartis clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Completion of Genentech Study Q2143g, Q2195g, or Q2461g or Novartis Study CIGE025 0010E1
* Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
* Females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
* Severe asthma as demonstrated by at least one of the following: \*History of prior intubation for allergic asthma; \*History of prior admission to an intensive care unit/pediatric ICU for asthma; \*History of one or more hospitalizations, emergency room (ER) visits, or unscheduled office visits for asthma in the 12 months prior to first Xolair treatment; \*More than 20 days missed from school/work because of allergic asthma in the 12 months prior to initiation of Xolair treatment
* Deterioration of asthma upon withdrawal of Xolair as demonstrated by meeting at least one of the following: \*Worsening of pulmonary function tests (FEV1 \<80% predicted for height, age, and sex) and activity levels while off Xolair treatment; \*Worsening of asthma exacerbations defined as doubling of inhaled steroid dose, increase in dose of oral steroids, or initiation of oral, intravenous, intramuscular, or subcutaneous (SC) steroids while off Xolair treatment; \*Increased use of rescue medications while off Xolair treatment; \*ER visits or unscheduled office visits for asthma that may or may not result in hospitalization while off Xolair treatment

Exclusion Criteria:

* Pregnancy or lactation
* Significant systemic disease (e.g., hematologic, renal, hepatic, coronary heart, endocrine, gastrointestinal disease, other cardiovascular diseases, or infection) within the previous 3 months
* History of neoplasia (including basal cell carcinoma)
* Any systemic condition requiring regular administration of an immunoglobulin
* Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
* Current treatment with warfarin (Coumadin(R)), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy
* Current participation in a study using an investigational new drug other than Xolair
Impact of Psychology on Life Quality in Chronic and Cancer Pain Patients

This study is to compare the effect of pain management program. We compare life quality, pain scores, sleep, anxiety and depression scores, and self report measures before and after mindfulness based pain management workshops.

Chronic pain is a growing problem in modern society. One in every five person in developed countries have this condition. Chronic pain is pain that persists longer than six months. It lead to psychological disorders such as anxiety, depression, anger and chronic fatigue. It decreases life quality, lower self-esteem and decrease work force. Because of these factors and the high cost of treatment, it impacts social economics highly. Chronic pain is caused by wind-up effect of the nervous system which the inhibitory signals are impaired. The nervous systems is therefore tuned up. Mindfulness based pain management helps lower this wind-up effect by noticing self, to observe and release stress. It has been proven to alter brain activity, enhance self control, improve attention and decrease secretion of stress hormones. It decreases pain and allow patients to regain control of life.

Eligibility Criteria:
Inclusion Criteria:

* Pain condition for over six months, with diagnosis by pain physician to be of chronic pain or cancer pain.

Exclusion Criteria:

* Patients unable to communicate in Mandarin.
ToT and Estrogen in Postmenopausal Females

To compare the subjective and objective outcomes of TVT-O procedure alone versus the same procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female with genuine stress incontinence.

a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female

Eligibility Criteria:
Inclusion Criteria:

-menopause patients included in group A should have: no history of breast cancer, ovarian cancer or uterine cancer No history of blood clots or thromboembolism No history of heart disease or stroke No history liver disease. Endometrial thickness less than 5mm Have a normal mammogram

Exclusion Criteria:

* presence of urge or mixed incontinence .
Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain

The primary objective of the study is to investigate the efficacy of device with far-infrared (FIR) irradiation in these patients with acute cervical radiculopathy.

Acute neck pain is a relatively common experience that usually declines and disappears within a couple weeks. Some patients do not recover and with time develop chronic cervical pain and nerve root compression which may result in cervical radiculopathy.

Far-infrared (FIR) ray is one of the topics in energy medicine which is tremendously studied for the past few years. A variety of FIR applications showed an enhancement of beneficial effects on healing therapy, even though there is limited technical approach and systemic study placed on the theoretical study of FIR ceramics processing and the emissivity optimizing.

The evident difficulties in finding the appropriate cervical radiculopathy therapy initiated the current study. The aim of the study is to evaluate the efficacy of the FIR cervical collar in patients with long-lasting cervicobrachial pain; in whom the pain had a distribution that corresponded to a specific nerve root compression revealed by MRI or electrophysiological study.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 20 years
* Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following:

  1. Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
  2. Muscle weakness in one or more adjacent myotomes.
* Neck Disability Index (NDI) score greater than or equal to 10 points
* Visual analog scale (VAS) score for neck pain greater than or equal to 40mm
* C-spine X-ray signs judge by investigator
* Prolong Neck pain for one week or longer
* Written consent from patient

Exclusion Criteria:

* Serious somatic or psychiatric disease(s)
* History of spinal tumors or spinal infection
* Ongoing physical therapy within 4 weeks
* Cervical instability judge by investigator
* History of contact dermatitis or known allergic reaction to collar material
* Known allergic reaction to acetaminophen
* Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study
Resisted Sprint and Plyometric Training on Lower Limb Functional Performance in Young Adult Male Football Players.

This study aims to evaluate the short-term effects of resisted sprint training on sprint performance together with lower limb physiological and functional performance in young professional football players.

Ninety collegiate football players were recruited, with a mean age of 20.48 at the university campus. All of which were randomly divided into two experimental groups RST(n=30), PLT (n=30) participated in training for six weeks on alternate days (i.e., three sessions per week) and one control group (n=30) did not train. The control group was instructed to maintain regular activities and avoid any strenuous physical activity during the study. No significant between-group baseline or pre-to-post-training differences in anthropometrics were observed.

Under the Declaration of Helsinki, participants were informed about the study's possible risks and benefits, and all participants have signed informed consent before participation in the study. Ethical sub-committee of College of applied medical science, Majmaah, Saudi Arabia approved this study (Ethics Number: MUREC-Dec.15/COM-2020 / 13-2).

Eligibility Criteria:
Inclusion Criteria:

* Young players aged between 18 and 25 years required frequent sprinting

Exclusion Criteria:

* Current injury to lower limb.
* Surgery affecting lower limb function.
* Any cardio-respiratory diseases.
* Impairments of spine or lower extremities.
Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 20-40
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply.
A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers

This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject aged 19 to 50 years, at screening
* A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0\~30.0 kg/m2
* A subject who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator within 28 days before the first administration of the investigational drug
* A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
* A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.

Exclusion Criteria:

* A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
* A subject who has an acute illness within 28 days prior to the first dose of investigational drug
* A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
* A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
* A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
* A subject who is judged unsuitable to participate in this study by the principal investigator
Prosthetic Breast Reconstruction After Mastectomy

Breast cancer represents a disabling diagnosis for women, and the related destructive surgical intervention of mastectomy inevitably affects their social, relational and working life. The primary aim of post-oncological breast reconstruction is to restore volume, shape and projection as similar as possible to the contralateral breast, in unilateral mastectomies and between the two reconstructed breasts, in bilateral mastectomies, avoiding the patient the need to resort to uncomfortable and unsightly external prostheses.

The study in question has a purely observational and non-interventional nature, in order to evaluate whether today the traditional EXP-IMPL prosthetic reconstructive technique represents an obsolete option or whether it can still be considered a valid alternative in clinical, anthropometric and patient satisfaction terms

The primary aim of post-oncological breast reconstruction is to restore volume, shape and projection as similar as possible to the contralateral breast, in unilateral mastectomies and between the two reconstructed breasts, in bilateral mastectomies, avoiding the patient the need to resort to uncomfortable and unexpectedly external prostheses.

The study in question has a purely observational and non-interventional nature, in order to evaluate whether today the traditional EXP-IMPL prosthetic reconstructive technique represents an obsolete option or whether it can still be considered a valid alternative in clinical, anthropometric and patient satisfaction terms. In order to evaluate outcomes in prosthetic breast reconstructions immediate (DTI - Direct to Implant) and in two surgical stages (EXP-IMPL - expander/prosthesis), after mastectomy, the aforementioned data will be subjected to appropriate statistical analysis

Eligibility Criteria:
Inclusion Criteria:

* Sex F
* Patients undergoing mastectomy (R-m, SS-m, NSS-m)
* Age 18 - 70
* Prosthetic breast reconstruction (DTI or EXP-IMPL)
* Written informed consent

Exclusion Criteria:

* Autologous breast reconstruction
ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease

The primary objective of this feasibility study is to evaluate the safety of DBS-f in patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse events. The secondary objective is to preliminarily estimate the treatment effect size on the outcomes of interest at 12 months post-randomization. The objectives do not involve formal tests of hypotheses.


Eligibility Criteria:
Inclusion Criteria:

1. 45-85 years of age (inclusive)
2. Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
3. Must meet certain criteria on cognitive and behavioral rating scales
4. If female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study.
5. An available caregiver willing to participate.
6. Subject is living at home and likely to remain at home for the study duration.
7. The subject is currently taking a stable dose of cholinesterase inhibitor (AChEI) medication for at least 60 days

Exclusion Criteria:

1. Must meet certain criteria on cognitive and behavioral rating scales
2. Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
3. History of head trauma in the 2 years prior to signing the consent to participate in the study
4. History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI
5. Active psychiatric disorder
6. Mental retardation
7. Current alcohol or substance abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
8. Contraindications for PET scanning (e.g., insulin dependent diabetes)
9. Contraindications for MRI scanning, including implanted metallic devices (e.g. non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
10. Abnormal lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
11. Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
12. Unstable doses of any medication prescribed for the treatment of memory loss or Alzheimer's disease.
13. Currently prescribed any non-AD medications that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
14. Is unable or unwilling to comply with protocol follow-up requirements.
15. Has a life expectancy of \< 1 year.
16. Is actively enrolled in another concurrent clinical trial.
Adaptation of the PCIP for Spanish Speaking Adolescents and Families

This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smart phone delivery), to 10 Spanish speaking youth and their families.

Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness.

Following RE-AIM guidelines, the investigators will assess:

Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings.

To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers.

This treatment ranges from 1-3 sessions which last 30-50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.

All treatment materials have been developed in both Spanish and English.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred to the SHARK Program
* Patients must be at least 12 years old
* Screened for probable PTSD on Brief UCLA Reaction Index, or at provider discretion of clinical relevancy.
* If patient is under 18 years old, the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study in English or Spanish;
* Patient is able to complete study activities in English or Spanish.

Exclusion Criteria:

* Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;
* Patient is over the age of 22