cyrilzakka/clinical-trials huggingface dataset:
Yoga for Men Attempting Smoking Cessation

The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control.

Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health \& wellness program that serves as a control for number of contacts and subject burden between study conditions. Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes. Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.

Eligibility Criteria:
Inclusion Criteria:

* male
* age 18 -65
* daily smoker, 5 or more cigarettes/day
* generally healthy
* able to exercise safely

Exclusion Criteria:

* female
* hypertension
* current or recent history of medication use for major depression
* participation in yoga classes within the past year
* current or \>1 year prior experience with mind/body therapies
* currently participating in regular exercise classes
* currently enrolled in quit smoking program
* currently using quit smoking medications
Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula

A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants.

The purpose of this study is to examine the tolerable and acceptability of an infant formula with with a Whey protein concentrate containing alpha-lactalbumin as measure by GI tolerance, and eating behaviors.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Healthy, full term, singleton infant
3. Be between 28±7 days post-natal age
4. Infants at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts
5. Infants must be exclusively consuming and tolerating a cow's milk infant formula for a minimum of 3 consecutive days and parent(s)/LAR must have previously made the decision to continue to exclusively formula feed
6. Have sufficient command of Tagalog or English language to complete the informed consent and other study documents
7. Are willing and able to fulfill the requirements of the study protocol
8. Have reached the legal age of consent in the Philippines
9. Able to be contacted by telephone throughout the study

Exclusion Criteria:

1. Infants who are receiving any amount of supplemental human milk
2. Family history of siblings with documented cow's milk protein intolerance/allergy
3. Conditions requiring infant feedings other than those specified in the protocol
Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

The aim of this study is to evaluate the outcome of capsular in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma. The investigators included children with cataract planning to have cataract surgery in our institute. Exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations. The investigators recorded age at surgery, gender and relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy, slit lamp adapted anterior segment photography.All patients were examined at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, and two years after surgery. Patients were followed for two years or until the development of severe VAO requiring Nd: YAG laser capsulotomy, whichever came first. The examinations consisted of visual acuity, IOP measurement by a Tonopen tonometer (Reichert, Inc., Seefeld, Germany), fundoscopy, an assessment by high-resolution digital retroillumination imaging (detailed protocol presented below).The primary outcomes were the areas of the posterior capsular opening at different postoperative follow-up visits and during operation.A paired T test was used to compare the areas of the PCO between the postoperative visits and baseline.


Eligibility Criteria:
Inclusion Criteria:

Participants included eyes of children with unilateral or bilateral cataract.

Exclusion Criteria:

Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis, or surgical complications, as well as those whose pupils could not dilate normally postoperation or who could not complete the follow-up, were excluded.
Blood Types and Erectile Dysfunction

The researchers aimed to investigate the relationship between ABO blood types and erectile dysfunction.

This retrospective study is done in Ordu university Hospital among patients who administered to urology polyclinic between April 2013 and April 2014. Sexually active 102 patients whose blood types were known were included in this study. While 56 patients had sexual intercourse problems 46 had not and this group was taken as a control group. Individuals who had a sexual partner and whose sexual intercourse were continuing unproblematic ally were accepted as normal. Individuals who had not have sexual intercourse though having a sexual partner or unable to maintain the intercourse were accepted to have sexual dysfunction. Patients' sexual function was evaluated via the İEFF-5 questioning form. In the same session the patients' blood types were also recorded and their İEFF-5 (Erectile Function International Evaluation Form) symptom scores were compared with their blood types.

Eligibility Criteria:
Inclusion Criteria:

* Male, person who have sexual intercourse

Exclusion Criteria:

* Female, who have no sexual intercourse
PREPARE - Primary Prevention Parameters Evaluation

The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac Resynchronozation Therapy) device. The information learned from this study could be used to guide physicians in future ICD or CRT device programming.


Eligibility Criteria:
Inclusion Criteria:

Patient is a candidate for a non-replacement Medtronic ICD device from the Marquis family or has had a non-replacement Medtronic Marquis based ICD system implanted within the previous 6 months and has not had any appropriately treated spontaneous VT/VF episodes during that time.

Exclusion Criteria:

Patient has history of spontaneous sustained symptomatic ventricular arrhythmias.

If patient has had an electrophysiology test in the past, and has sustained inducible VT \<180 bpm.
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults

The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.

Primary Objective:

To assess the immune response to the vaccine

Secondary Objectives:

To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine

Safety Objective:

To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine

The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 18 to 45 years old (inclusive)
3. Using an acceptable method of contraception (if female of childbearing potential).
4. Able and willing to provide informed consent for study participation.

Exclusion Criteria:

1. Current acute febrile illness.
2. Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
3. Pregnant or breast-feeding.
4. Laboratory evidence of infection with Hepatitis B/C or HIV.
5. History of chikungunya virus infection.
6. Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day 1.
7. History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
8. Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day 1.
9. Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day 57.
10. Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
11. Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
12. Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
13. Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 \& 10 only).
14. Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 \& 10 only).
15. Weight \< 110 pounds (Group 9 \& 10 only)
International Registry for Intraductal Papillary Mucinous Neoplasma

A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.

Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized in clinical practice. They represent a unique clinicopathologic entity that is characterized by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996. Recent literature suggests that up to 45% of IPMN are malignant and should be resected; however these data are based on larger, primarily symptomatic lesions. Several studies have been published in the recent literature reporting single-center experience with IPMN resections and observations with small numbers of patients. The natural history of these lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN were published in 2006, but noted the limited knowledge available in six areas: definition and classification, preoperative evaluation, indication for resection, method of resection, histological data on frozen section/positive margins and specimen processing, and finally, method of follow-up. Speaking to this need, we propose an international registry for multi-center collaboration in the above areas of need in IPMN research and clinical management. This will be through a centralized, web-based registry with data entered by each center in a de-identified way to protect confidentiality.

The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be incorporated into this data base. Any patients that participate in the prospective study will be consented with HIPPA consent prior to collection of data.

Eligibility Criteria:
Inclusion Criteria:

* Suspected IPMN based on the consensus guidelines (7)
* Endoscopic ultrasound imaging at baseline examination
* Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year
* Cases previously collected that meet the above criteria will be allowed

Exclusion Criteria:

* Patients who do not meet the above inclusion criteria
Turkish Validation Study of Endometriosis Health Profile -30 (EHP-30) Test

For the Turkish validation Study of the Endometriosis Health Profile test (EHP-30) consisting of 30 questions, this 30-question test will be applied to 228 patients after 2 different translations to be applied after the translation of this 30-question test sworn translator to the patients who have been surgically diagnosed with endometriosis.

The appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic. English and Turkish translation will be verified after 2 different sworn translators.

Eligibility Criteria:
Inclusion Criteria:

* being surgically diagnosed with endometriosis
* Age between 18- 45
* not being pregnant

Exclusion Criteria:

* have been diagnosed with endometriosis by ultrasound
* above 45 and under 18 years old
* use psichiatrig drugs
* being diagnosed with a psychiatric illness
A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib, lorlatinib, or other ALK inhibitors that may become available during study treatment.

This is a prospective and non-interventional study of participants with ALK+NSCLC. The study will seek to determine the real-world differences in the PFS of participants taking brigatinib or any FDA approved ALK inhibitor other than crizotinib in routine clinical practice and will evaluate participant's quality of life, daily function, general condition, and treatment satisfaction.

The study will enroll approximately 160 participants: 80 participants taking brigatinib, and 80 participants taking FDA approved ALK inhibitors other than crizotinib. Participants will be enrolled in one of the 2 cohorts:

* Brigatinib
* Any FDA Approved ALK Inhibitor Other Than Crizotinib

This trial will be conducted in the United States. Upon enrollment into the study, participants will complete a study-specific baseline questionnaire and four validated instrument questionnaires. After that, participants will complete a study-specific monthly questionnaire and four validated instrument questionnaires, which will be made available to participants every 30 days. Participants will be sent automatic e-mail reminders every 30 days when new surveys become available. All participants will receive a notice on completion of their participation in the study at approximately 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Has ALK+ NSCLC.
2. Has been prescribed:

   * Brigatinib at any point in therapy, OR
   * Any FDA approved ALK inhibitor at any point in therapy other than crizotinib. Participants who were previously on crizotinib, but are now on another ALK inhibitor are eligible for study participation.
3. Has internet access.
4. Is willing to answer regular e-surveys and allow for the prescriber or clinic to provide data on the status of the participant's NSCLC.

Exclusion Criteria:

1. Has received any investigational compound within 90 days prior to consent.
Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap

Primary objective of the study is to compare and evaluate the impact of intensive care of rehabilitation of psychomotor vs. the standard care on adaptive behaviour of children with polyhandicap at 12 months after randomization.

As secondary objectives, the study aims to:

1. compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on:

   * result of evaluation with Vineland Scale of adaptive behaviour at 6 months after randomization;
   * result of evaluation with Brunet-Lézine Scale of developement at 12 months after randomization;
   * the pain evaluation at 12 months after randomization;
   * the durability of acquired cognitive-motor improvement at 6 months after the end of intervention (18 months after randomization);
   * the quality of life of the patients' family or relatives at 12 months after randomization;
   * the clinical global impressions and the quality of life for work for the long-term professional caregivers at 12 months after randomization.
2. evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.
3. study the concordance between the Vineland scale and the Brunet-Lézine scale.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4 and 13 years;
* With polyhandicap defined by association of the 5 following criteria:

  * Causal brain injury occurred before the age of 3 years
  * Severe or deep mental deficiency as defined by IQ \< 40, or no evaluable by the psychometric tests
  * Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders
  * Score of Gross Motor Function Classification System \[Palisano 1997\] is III, IV or V
  * Score of Functional Independence Measure \< 50;
* Hospitalization in a clinical setting participating to the study;
* Beneficiary of a social protection;
* Written consent signed by personnel holding parental authority or legal representative.

Exclusion Criteria:

* Patient with progressive encephalopathies including metabolic origin, epileptic, or neurodegenerative diseases;
* Planned to move in another clinical setting;
* Foreseeable difficulty in the following up in the study.
Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients

* Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty
* Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease.

The variables are:

Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes

Eligibility Criteria:
Inclusion Criteria:

* Adult Patient
* BMI \< 35
* no Benzodiazepinec User

Exclusion Criteria:

* BMI \> 35
* Use of benzodiazepinecs
* Clinical contra-indications to surgery (ASA III or ASA IV)
Effect of Opioids on Experimental Hyperalgesia in Oesophagus, Skin and Muscles

The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids, Oxycodone and Morphine will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin by capsaicin and in oesophagus by a mixture of capsaicin and acid, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years
* Signed informed concent
* Healthy
* Women must use a safe contraceptive method
* Negative pregnancy test

Exclusion Criteria:

* Pregnancy
* Allergy to study medication
* Participating in another medicine study
* Previous addictive behaviour
* Need for other treatments
* Use of strong analgesics
* Use of any analgesics 24 hours before the study
Family Nurture Intervention, A Group Model in Connecticut

The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.

There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.

Eligibility Criteria:
Inclusion Criteria:

* Child is a singleton
* Mother can speak in English or Spanish
* Child is between the ages of 2 to 4 ½ years at date of enrollment
* Mother is 18 years of age or older at the time of consent
* Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better)
* Child must reside with mother

Exclusion Criteria:

* The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
* The child has a diagnosis of Autism
* The child has severe motor or physical disability
* Mother currently presents with psychosis or is currently taking antipsychotic medication
* Current maternal drug and/or alcohol abuse
* Mother has any current involvement with Child Protective Services (Department of Children and Families)
* Mother is pregnant
* Mother and/or infant has a medical condition or contagion that precludes intervention components