cyrilzakka/clinical-trials huggingface dataset:
Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

Adalimumab has recently been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.


Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
* Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol

Exclusion Criteria:

* Participants should not be enrolled if they cannot be treated in accordance with the local product label
* Participants enrolled into another study or clinical trial
* History of hepatitis B infection
* History of neurologic symptoms suggestive of central nervous system demyelinating disease
* History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
* Active tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment
* Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
* Use of another anti-tumoral necrosis factor previously
* History of congestive heart failure
* Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk
* Participants with active infection including chronic or localized infections until infections are controlled
* History of sensitivity to latex
* Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy
Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes

World health Organization (WHO) estimates that by 2030, 1.2 billion women will be over 50 years old. With a prevalence of 70%, a hot flash is the most distressing symptoms associated with menopause. Postmenopausal associated sleep disturbances could affect those women social activities and one's daily positive functioning. Therefore, some patients and their providers seek alternative treatments such as relaxation techniques, acupressure, yoga, reﬂexology, regular exercise, balanced nutrition, herbal supplements, appropriate clothing, and frequent showers, have been shown to be effective in reducing symptoms associated with depression. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.

Fifty-four postmenopausal women suffering from moderate to severe hot flashes diagnosed with hot flashes questionnaire, and sleep disturbances diagnosed with Pittsburgh quality sleep index \>5. Their age ranged from 45-55 years old with their body mass index ranged from 25 to 30 kilogram per meter square. Outcome measures were Pittsburgh sleep quality index and Hot flashes questionnaire, both were conducted at baseline and after the end of the study program. after recruiting study population, they will be divided into two equal groups randomly. Group A; will received foot reflexology (medical border just above the heel, reflex points associated with adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone), for 15 minutes, 3 sessions per week for 6 weeks. Group B; will received acupressure ((Shenmen point, Sanyinjiao point, Fengchi point; Yintang point), for 21 minutes, 3 sessions per week for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 45 to 55 years old.
* Their body mass index ranged from 25 to 3 kilograms per meter square.
* Postmenopausal women suffering from moderate to sever hot flashes assessed by Hot Flashes Questionnaire.
* Postmenopausal women suffering from sleep disturbances more than five assessed by Pittsburgh sleep quality index.

Exclusion Criteria:

* Any emotional stress during at least 6 months.
* Any pharmacological medicines lead to sleep disturbances.
* Any mental disorders affect their sleep cycle.
* Taking hormone replacement therapy for the past six months.
* Using herbal medicine to improve menopausal symptoms severity.
* Circular job in particular night shifts.
* Sensorineural problems in their feet.
Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

The study goal is to develop exercise intervention methods to improve the prognosis and quality of life of patients with non-tuberculous mycobacterial lung disease and to confirm the effectiveness of exercise intervention. This prospective study is scheduled to be conducted as a pre-post single-arm feasibility trial, targeting a total of 50 subjects.

1. After confirming the intention to participate in the study for patients with non-tuberculous mycobacterial lung disease who meet the selection criteria, basic personal information and clinical history information are collected.
2. When three people are recruited, they are organized into one group and begin a four-week exercise program. A total of 17 groups will be recruited and 50 people will be registered, and within 1 week before and after the start of the exercise program, VO2 max, physical function (6MWT, 30s sit to stand, SPPB, Handgrip strength), Baseline PFT, Laboratory test, Quality of life test (QOL) -B, CAT) is performed.
3. Once a week for 4 weeks, full-body strength training and aerobic exercise are performed for 60 minutes with an exercise expert (supervised exercise), and the remaining 6 days a week are home-based exercises, in which the subject exercises independently at home. Write it down in participants exercise diary.
4. VO2 max, physical function (6MWT, 30s sit to stand, SPPB, handgrip strength), PFT, laboratory test, and quality of life test (QOL-B, CAT) are conducted again within one week before and after the exercise intervention is completed.

Eligibility Criteria:
Inclusion Criteria:

Adults aged 19 to 80 years diagnosed with non-tuberculous mycobacterial lung disease according to the ATS/IDSA guideline, Patients with respiratory symptoms (cough, phlegm, difficulty breathing, etc.) at the time of selection, Patients who understand the purpose of the clinical study and voluntarily agree to participate in this clinical study

Exclusion Criteria:

Patients diagnosed with cardiovascular disease (Angina, HFrEF, arrhythmia, history of heart valve surgery, etc.), Patients who have had massive hemoptysis within the last 3 months, Patients who have difficulty moving freely due to musculoskeletal problems (osteoarthritis, intervertebral disc herniation, spinal stenosis, etc.), Patients who cannot read the consent form (e.g. illiterate, foreigner, etc.)
A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

The purpose of this study is to compare the safety and effectiveness of topiramate (64mg, 96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.

Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and effectiveness of topiramate in treatment of obese patients. Patients will receive 24 weeks of treatment by topiramate or placebo, followed by 2 week taper and a safety follow-up. Effectiveness will be determined by changes from baseline to week 24 in body weight, body mass index (BMI), anthropometric measurements (waist circumference, hip circumference, waist/hip ration), fasting lipid profiles, fasting plasma glucose, HbA1c (shows average blood sugar level over months), fasting uric acid, fasting insulin, and blood pressures. Safety evaluations (incidence of adverse events, physical examinations, 12 lead ECGs, vital signs, Computerized Neuropsychological Test Battery) will be performed throughout the study. The study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients and is well tolerated. The patients will be randomized to receive either topiramate (64, 96, 192, or 384 mg daily) or placebo daily by mouth for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \>=30 and \<50
* BMI \>= 27 and \< 50 if patient has controlled hypertension or abnormal blood lipids
* Stable weight
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Known contraindication, or hypersensitivity to topiramate
* Exposure to any other experimental drug or device within last 30 days
* A diagnosis of diabetes
* History or evidence of clinically significant liver disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels
* History of obesity with known cause
* History or family history of kidney stones
* History of weight loss surgery
* History of malignancy within last 5 years
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder.

After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19-65
2. Receiving treatment for Alcohol Use Disorder

Exclusion Criteria:

1. MRI Contraindications

   1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
   2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
   3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS
2. TMS Contraindications

   1. Has ever had a seizure, or has a family history of epilepsy
   2. Taking medications or substances that lower the seizure threshold
   3. Implanted devices that are in the head or rely on physiological signals
   4. History of neurological disease, such as stroke or brain tumor
   5. Head injury with loss of consciousness greater than 30 minutes
   6. Actively withdrawing from alcohol
3. Family history of schizophrenia or presence of psychotic symptoms
Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab

The primary objective of the study is to determine the association between prospectively measured disability (Expanded Disability Status Scale \[EDSS\]) with quality of life (Multiple Sclerosis International Quality of Life Questionnaire \[MusiQoL\]) at 3-month intervals up to 1 year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The secondary objectives of this study are as follows: To evaluate the cumulative probability of sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function \[FSMC\]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 \[MSISQ-19\]), depression (Beck Depression Inventory-Fast Screen \[BDI-FS\]) and neurocognitive function (Symbol Digit Modalities Test \[SDMT\]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to 6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse) and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe changes in work impairment (Work Productivity and Activity Impairment in MS \[WPAI-MS\]) at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe any change in the percentage of disability pension and occupation after 1 year of natalizumab treatment; To record the incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) throughout the study


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects that have a confirmed diagnosis of RRMS, as per the 2010 revised McDonald criteria
* Subjects satisfying the therapeutic indication of natalizumab, as described in the local product label and confirmed by the Investigator. (Patients with previous treatment with natalizumab are also considered to be eligible only if the last natalizumab infusion was at least 1 year before the screening visit of this study)
* Decision for a treatment with natalizumab has been made before screening
* Patients with an EDSS score of 2.0-5.5 (both limits inclusive)

Key Exclusion Criteria:

* Patients with a diagnosed co-existing brain pathology other than MS, which in the judgement of the investigator impacts the value of EDSS or QoL.
* Pure spinal manifestation of demyelination
* Diagnosis of primary or secondary progressive MS
* Any change in concomitant medication known to affect cognition or bladder function
* A history of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse, as assessed by the Investigator

NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.
A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)

The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography / computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions in patients who are receiving enzalutamide for castration-resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
* Presence of bone metastatic disease as assessed by at least two lesions on whole body metastable technetium-methylene diphosphonate (99mTc-MDP) bone scintigraphy;
* Throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) analogue or prior bilateral orchiectomy (medical or surgical castration);
* Testosterone ≤ 1.73 nmol/L (≤ 50 ng/dL) at screening;
* Progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (PSA) values (PSA1 \< PSA2 \< PSA3);
* The screening PSA (PSA3) must be ≥ 2 μg/L (≥ 2 ng/mL).

Exclusion Criteria:

* Prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium Ra 223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the CRPC setting for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
* Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than LHRH analogue therapy) within 4 weeks before enrollment;
* Initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;
* Use of an investigational agent within 4 weeks before the screening visit;
* Radiation therapy to bone within 4 weeks before enrollment;
* Use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment;
* Screening 99mTc-MDP bone scintigraphy showing a superscan;
* Visceral (eg, lung, liver) metastatic disease. Adenopathy is allowed;
* Current or previously treated brain metastasis or active leptomeningeal disease;
* History of seizure any time in the past for any reason or any condition that may predispose to seizures.
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth

Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.


Eligibility Criteria:
Inclusion Criteria:

* Must be residents of rural Manitoba (Canada)
* Must meet research diagnostic criteria for insomnia
* Must have access to a computer and high-speed internet

Exclusion Criteria:

* Comorbid conditions (medical and psychiatric) must be stable
Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults

The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.


Eligibility Criteria:
Inclusion Criteria:

* At least 65 years old
* Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months)
* Can ambulate independently
* Has mild cognitive impairment

Exclusion Criteria:

* Do not live in a community setting
* Cannot ambulate independently and communicate with researchers
* Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
* Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)
Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment

RATIONALE: Antiemetic drugs, such as ondansetron, may help to reduce or prevent nausea and vomiting in patients with advanced cancer.

PURPOSE: This randomized phase III trial is studying how well ondansetron works compared to a placebo in treating patients with advanced cancer and chronic nausea and vomiting that is not caused by cancer therapy.

OBJECTIVES: I. Compare the antiemetic effect of ondansetron vs placebo in patients with advanced cancer who suffer from chronic nausea and emesis that is not due to antineoplastic therapy (i.e., chemotherapy, radiotherapy, immunotherapy, biologic therapy). II. Determine the toxicity of ondansetron in these patients. III. Evaluate the use of other concurrent antiemetics in these patients when treated with this regimen.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to abdominal carcinomatosis (yes vs no), renal insufficiency (creatinine less than 2.0 mg/dL vs creatinine at least 2.0 mg/dL), type of cancer (brain vs gastrointestinal vs other), and narcotic use (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral ondansetron twice daily on days 1-7 and oral placebo twice daily on days 8-14 in the absence of unacceptable toxicity. Arm II: Patients receive oral placebo twice daily on days 1-7 and oral ondansetron twice daily on days 8-14 in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of incurable cancer with chronic nausea and vomiting lasting at least 1 week that is not due to antineoplastic therapy (i.e., chemotherapy, radiotherapy, immunotherapy, biologic therapy) Nausea not adequately controlled by standard antiemetics

PATIENT CHARACTERISTICS: Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing Able to take oral medication (feeding tube allowed) Able to swallow own saliva No prior phenylketonuria No known allergy or intolerance to 5-HT3 receptor antagonists No bowel obstruction

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 2 weeks since prior cytotoxic systemic therapy No concurrent cytotoxic systemic therapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy to gastrointestinal tract No concurrent radiotherapy to gastrointestinal tract Surgery: Not specified Other: At least 2 weeks since prior 5-HT3 receptor antagonists (i.e., dolasetron, granisetron, or ondansetron) No other concurrent 5-HT3 receptor antagonists Other concurrent antiemetics allowed
BIO|MASTER.Ilivia Family / Plexa

Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region


Eligibility Criteria:
Inclusion Criteria:

* Standard indication for ICD or CRT-D therapy according to clinical practice
* De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant
* Patient is able to understand the nature of the clinical investigation and provides written informed consent
* Patient is able and willing to complete all routine study visits at the investigational site
* Patient accepts Home Monitoring concept
* Age ≥ 18 years

Exclusion Criteria:

* Contraindication to ICD or CRT-D therapy, respectively
* For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient
* Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary.
* Expected to receive heart transplant or ventricular assist device within 6 months
* Life expectancy less than 6 months
* Participation in any other interventional clinical investigation
* Pregnant or breastfeeding at time of enrollment