cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo Patients

Patients of non-segmental vitiligo, fulfilling the inclusion criteria will be selected from the OPD, dermatology department. It\&#39;s an interventional study where Group A patient will be given NBUVB and Tab Apremilast 30 mg twice a day and Group B will receive NBUVB alone.

Patients of non-segmental vitiligo, fulfilling the inclusion criteria will be selected from the OPD, dermatology department Dow university hospital. Informed consent will be obtained from all the patients.

Demographic details of patients including age, gender, education, occupation and marital status will be obtained. Further each patient will be asked about duration of vitiligo and any systemic medications used by the patients in the last 6 months will be recorded.

Body Surface Area will be calculated and patients with \&gt; 5% of BSA will be included in the study.

Subjects will be randomly divided by lottery method into two groups. Group A patients will be given NBUVB and Tab Apremilast 30 mg twice a day, and Group B patients will receive NBUVB alone.

Hematological baseline including CBC and LFTs will be advised to patients in Group A.

Vitiligo Area Severity Index (VASI) will be used to initially assess the patient at the baseline and later on to assess the regimentation in each of the patients of vitiligo on next 4 follow-ups. Each follow-up will be after every 8 weeks for a total of 32 weeks. CBC and LFTs will be repeated in Group A after 4 weeks of starting tab Apremilast 30 mg BD and then after 3 months. Any side effects seen during the study period will be recorded and managed accordingly DLQI Dermatological Life Quality Index (DLQI) questionnaire will be conducted with 30 vitiligo patients at the baseline and at the end of therapy.

All results will be collected and filled in proforma by the researcher. The results will be assessed statistically at the end of the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years and above
* Patients of both genders (male and female)
* Diagnosed patients of non-segmental vitiligo involving \> 5% of BSA

Exclusion Criteria:

* Pregnant and lactating women
* Concomitant active infection like tuberculosis
* Personal history of cutaneous malignancy
* Use of apremilast in the past 4 weeks
* Use of phototherapy within 4 weeks before randomization
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts

The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).

Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in \> 95% of lesions). GW are sexually transmitted and affect about 1% of the sexually active population. GW represent a distressful condition for social and sexual life, especially in the cases of external condylomas. No HPV-specific antiviral treatment exists to date, and all existing therapies (either surgical or drug) have limited efficacy, with a significant level of GW recurrences and are associated with local skin reactions. AP611074 is a synthetic new chemical entity that is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication and thus viral production. AP611074 is the "first in class" specific HPV antiviral described to treat condyloma caused by HPV infection.

Eligibility Criteria:
Main Inclusion Criteria:

* Male or female patient aged between 18 and 55 years.
* External condylomas, 1-15 lesions, non-confluent and individually isolated.
* Lesions must not be internal (ie, they must not penetrate the urethral meatus, vagina or anal canal); their visualization must be complete by patients and investigators without major facilitation maneuvers and easily documented by digital pictures.
* Lesions should have a total surface smaller than 5 cm2, and an individual surface smaller than 1 cm2; lesions should be easily measured using a "French Catheter Scale".
* Lesions to be treated should have appeared between 1-6 months before screening and patients should not have received any previous condyloma treatment since their appearance.
* For patients having previous episodes of condyloma lesions, they shouldn't have received any condyloma treatment for at least 12 months before screening.

Main Exclusion Criteria:

* Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease that, in the Investigator's judgment, prevents the patients from participating to the study.
* Patients with VIN or PIN (intraepithelial neoplasia of vulva or penis; ie, Bowenoid papulosis), or genital disease (ie, lichen sclerosus, lichen planus, lichen simplex chronicus, dermatitis, psoriasis, bullous diseases, systemic diseases with genital manifestations) requiring treatment.
* Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma, or circumscribed lymphangiomas.
* Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study.
* Patients for whom a proper follow-up of the lesions during the study will not be possible, because of hair growth in the treatment area.
Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study

The purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* All patients ≥55 years of age undergoing intra-thoracic surgery for a resection of tumor in lung.

Exclusion Criteria:

* In AF prior to surgery\*,
* Undergoing minor thoracic interventions/ procedures (i.e., chest tube insertion, needle pleural/lung biopsies, or minor chest-wall surgeries), or
* With contraindications to colchicine (i.e., allergy, or myelodysplastic disorders or estimated glomerular filtration rate \[e-GFR\] \<30 mL/min/1.73m)

  * Clarification: Patients with history of AF who are in sinus rhythm during enrollment will be eligible for recruitment. Patients who have no history of AF and are found to be in AF at the time of enrollment will not be eligible.
The Influence of Storage Container and Defrost Process on Components in Breast Milk

Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.


Eligibility Criteria:
Inclusion Criteria:

* healthy mothers lactating during first year of their babies and have sufficient milk to donate

Exclusion Criteria:

* mothers who have insufficient milk for their babies
* mothers have major disease or on specific diet or drug which would affect breast milk composition
Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer

A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.

Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy with Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) Primary Objective: To determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.

Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmation of adenocarcinoma of the prostate.
2. Age \> 18 years.
3. Localized high-risk prostate cancer, defined as:

   * Stage III: T3 N0 M0, Gleason grade 8, 9, or 10, or
   * Stage IV: T4 N0 M0, any Gleason grade or Tx N1 M0, any Gleason grade
4. PSA \> 20 ng/mL.
5. Karnofsky index ≥ 70%
6. Good bone marrow reserve, with white blood cell count \> 3000/mm3, hemoglobin \>9.5 g/dL and platelets \> 150,000/mm3.
7. Absence of hepatic abnormality, with bilirubin values \< 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site.
8. Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
9. Having given informed consent in writing.

Exclusion Criteria:

1. Previous hormone treatment during more than 3 months.
2. Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
3. Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
4. Metabolic disease or uncontrolled systemic disease.
5. Previous history of grade III-IV neuropathy (NCI CTCAE v3).
6. Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
7. Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
8. Inflammatory bowel disease.
Understanding the Genetic Basis of Atherosclerosis and Peripheral Arterial Disease

Atherosclerosis, a condition in which fatty deposits build up along the inner walls of arteries, can occur throughout the body. The purpose of this study is to examine the possible genetic differences that may influence where atherosclerosis occurs.

Plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack, and stroke. Blockages of plaque can occur in different areas of the body. PAD, a circulatory disorder in which blockages occur in the peripheral arteries, is one manifestation of atherosclerosis. Individuals with PAD experience reduced blood flow to the legs, which may cause leg pain while walking. Coronary artery disease (CAD), in which plaque builds up in arteries leading to the heart, is another atherosclerosis-related condition. Individuals with PAD and CAD have similar atherosclerosis risk factors, but it remains unknown why some individuals develop one disease and not the other. Genetic differences may influence where atherosclerosis develops. The goal of the study is to identify genetic variations that may cause inherited differences in plaque distribution.

This study will enroll individuals with PAD who have been referred by their doctor for a coronary angiogram to confirm the presence of CAD. A control group composed of individuals who do not have PAD, but have similar risk factors for atherosclerosis, will also be enrolled. All participants will attend one study visit. They will undergo a coronary angiogram, a procedure in which a special dye is inserted intravenously into an artery of the heart. X-rays will be taken to document how blood flows through the artery. Questionnaires assessing quality of life, exercise habits, tobacco exposure, and family medical history will be completed. Participants will also undergo blood pressure measurements and blood collection for genetic analysis. Yearly follow-up phone calls will occur for 5 years to document any hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically significant PAD, as documented by an ankle-brachial index less than 0.9; control group participants will not have PAD
* Received a referral for an elective coronary angiogram
* Suspected CAD

Exclusion Criteria:

* History of radiation treatment
* History of organ transplant
* History of viral diseases (i.e. HIV, hepatitis)
Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors.

Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The vast majority of patients with cancer experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, most of the yoga intervention was delivered in person. With the challenges and the social distancing regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is critically important and needed. Whether the yoga intervention delivered virtually to survivors provides a similar benefit of improving insomnia and sleep quality is unknown.

PRIMARY OBJECTIVE:

To compare the effects of virtual YOCAS©® intervention to standard care on changes in insomnia measured via the Insomnia Severity Index among cancer survivors

SECONDARY OBJECTIVE:

To compare the effects of virtual YOCAS©® intervention to standard care on changes in sleep quality measured via the Pittsburgh Sleep Quality Index among cancer survivors

OUTLINE: Cancer survivors are randomized to 1 of 2 arms.

ARM I: Standard Care: Cancer survivors receive their standard care

ARM II: YOCAS©® intervention: Cancer survivors participate in 8 virtual YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via the electronic platform (e.g., Zoom)

Eligibility Criteria:
Inclusion Criteria:

Cancer Survivors must:

* have a confirmed diagnosis of cancer
* have received surgery, chemotherapy, and/or radiation therapy
* have completed all surgery, chemotherapy, and/or radiation therapy within the last 2 months to 10 years
* score ≥4 on a 0-10 sleep screening scale
* be at least 18 years of age
* be able to read and understand English
* be able to provide informed consent
* have access to the internet and a smartphone, tablet, and/or computer
* have the ability to attend 8 virtual yoga sessions

Exclusion Criteria:

Cancer Survivor must not:

* have contraindications to yoga participation
* have practiced yoga within the 3 months prior to enrolling in the study
* be planning to start yoga on their own during the time they are enrolled in the study
* have a confirmed diagnosis of sleep apnea or restless leg syndrome
* be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
* have distant metastases
Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux

The purpose of this study is to determine whether treatment with twice-daily Lansoprazole 30mg (Prevacid 30mg) and behavioral modifications for reflux is superior to treatment with behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (LPR).

Laryngopharyngeal reflux (LPR) is a disorder caused by acid-induced damage to the larynx and pharynx (voice box and throat). The standard care for persons with this disorder is treatment with highly potent anti-acid medications (proton pump inhibitors - Prevacid is one of these. NExium, Aciphex and Prilosec are others). These medications are currently approved by the FDA for the treatment of gastroesophageal reflux disease (GERD). Although the use of these medications in persons with LPR is widely accepted and sanctioned, this research is being done because these medications are not currently approved by the FDA for this use. The purpose of this study is to determine whether treatment with twice-daily Lansoprazole 30mg (Prevacid 30mg) and behavioral modifications for reflux is superior to treatment with behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (LPR).

Eligibility Criteria:
Inclusion Criteria:

* patients with a clinical diagnosis of laryngopharyngeal reflux diagnosed by any combination of patient symptoms, physical/endoscopic findings, and 24 hr dual-probe ambulatory pH-testing.
* 18 years of age or older

Exclusion Criteria:

* patients with life-threatening complications of laryngeal, pharyngeal or esophageal cancer, subglottic or tracheal stenosis, laryngeal papilloma, airway compromise
* elite vocal performs with LPR-related dysphonia
* under 18 years of age
* pregnant and/or lactating women
* persons with known hypersensitivity to any component of the formulation
* patients taking theophylline, ketoconazole, ampicillin or digoxin
* persons with hepatic and renal insufficiency
Patient Education Manual on Patients With Knee Osteoarthritis.

This RCT was conducted to see effects of patient education manual on pain, ROM and functional performance in patient of knee osteoarthritis. In this study the investigators were provide an educational manual as a home plan in which the investigators educate and guide patients about proper posture, life style modification, precautions and safety measures and home exercise in patient with knee osteoarthritis

This RCT was conducted to see effects of patient education manual on pain, ROM and functional performance in patient of knee osteoarthritis. In this study the investigators provide an educational manual as a home plan in which they educate and guide patients about proper posture, life style modification, precautions and safety measures and home exercise in patient with knee osteoarthritis.

The investigators will divide the patients in two groups. One group was treated with the patient education manual and routine physical therapy and the other group was treated with routine physical therapy alone. After baseline assessment patient was assessed at 2nd, 4th and 6th week and then do final assessment to analyse our results on SPSS, either patient education manual is helpful in minimising there pain functional limitation and increasing their Range Of Motion. Visual analogue scale, goniometry and WOMEC was used to measure outcome regarding pain, Range of motion and functional performance in patients with knee osteoarthritis. This study was help full in the management, to improve function and to decrease status of disability in future in patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria

* Idiopathic knee OA-I, II, \&III

Exclusion Criteria:

* Post Traumatic OA Knees
* Ligament instability
* Condromalacia patellae
* Knee replacements
* Cognitive impairment
* Rheumatoid arthritis
* Meniscus injury
Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder

The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial fibrillation (AF) among elderly patients with hypertension and at least one other risk factor for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30 to 60 days.


Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for inclusion if they meet all of the following:

1. Age ≥ 80 years
2. History of hypertension OR a blood pressure of ≥ 140/90 mmHg
3. Attending a primary care clinic, OR ambulatory resident of a chronic care facility
4. At least one of the following additional risk factors for developing AF:

   1. Diabetes
   2. Body mass index ≥ 30
   3. History of smoking
   4. Documented Obstructive sleep apnea
   5. Cardiovascular disease
   6. Heart Failure
   7. Left ventricular hypertrophy (on ECG or echocardiography)
5. Provide written informed consent

Exclusion Criteria:

1. ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes
2. Existing implanted pacemaker or defibrillator
3. Patients considered by the investigator to be unsuitable for study follow-up because the patient:

   1. is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder
   2. has a life expectancy less that the expected study duration due to concomitant disease
   3. has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -
Real-world Aliskiren Use in Diabetic Patients

The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Patients ages 18 yeras and older
* Hypertension Diagnosis
* Currently on at least 1 hypertensive medication
* At least 2 lab measure before and after aliskiren initiation

Exclusion Criteria:

* Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren
* Pregnancy
* Development of secondary renal disease unrelated to diabetes (such as nephritis)
* Terminal illness
* AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply
Prescription of Exercise in Children

Most pediatric populations do not meet the physical activity (PA) recommendations set by international organizations. The effectiveness of casual PA advice provided during medical consultations has not been adequately assessed for its role in fostering this healthy habit. This study aims to evaluate the effectiveness of medical prescriptions for PA in increasing PA levels in children compared to standard health advice (HA), as well as measuring the effectiveness of these recommendations in reducing daily screen time (ST) in the pediatric population. A randomized controlled clinical trial with parallel groups was conducted, including 130 participants aged 6 to 14 years. Data on PA levels (duration and intensity), ST, and anthropometric measures were collected via questionnaire. Participants were divided into two groups: HA (3 minutes) and medical prescription of exercise \[MPE\] (10 minutes). PA levels were assessed at 3 and 12 months, with results recorded using the same questionnaire. A multivariate data analysis was performed. Further research is needed to develop effective and sustainable public health interventions to prevent long-term sedentary behavior in children.

* Both HA and MPE interventions could effectively increase children's PA duration and intensity, resulting in a higher PA classification range.
* An inverse relationship may be identified between ST and PA, suggesting that reducing ST could encourage healthier habits in children.
* Pediatricians play a pivotal role in promoting lifestyle changes through brief yet targeted interventions, significantly influencing children's PA levels and reducing ST. These findings highlight the need for further research to optimize public health initiatives within pediatric care.

Eligibility Criteria:
Inclusion Criteria:

We included pediatric patients between 6 and 14 years of age who were part of two pediatric PC groups of an urban health centre in Granada (Spain) who attended a face-to-face consultation of any type.

Exclusion Criteria:

chronic or complex pathology preventing moderate or intense physical activity or those who did not give consent