cyrilzakka/clinical-trials huggingface dataset:
The Healthy Weight for Life Program

This study is a randomized controlled pilot of a work site weight control intervention. The purpose of the pilot is to obtain preliminary data for future NIH submissions. Four work sites were identified through a multistage recruiting process. Work sites were randomized to either the intervention group, which will receive the intervention immediately following randomization or the control group which will receive a shortened intervention over a 1-month period, 6 months after the active intervention sites have completed their program. The intervention will consist of a variety of activities conducted over a 6 month period, that are overseen by a work site-Tufts oversight group, including the following optional elements: For overweight and obese individuals, regular support groups for weight loss and prevention of weight regain. For all work site employees irrespective of weight, handouts and posted informational resources on healthy eating, monthly lunchtime seminars, and food sampling to facilitate healthy eating patterns for prevention of weight gain.

Basic online assessments on health and nutrition will be carried out at baseline (week 0) and 24 weeks in all work site employees willing to provide information. More detailed online and in-person assessments will be performed throughout the 24-week study period in the weight loss support group participants (intervention sites) and individuals intending to enroll in the support group (control sites).


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign a consent form.
* BMI during screening ≥25 kg/m2 (eligibility for weight loss support group)
* Participants must not have had any surgical procedures influencing weight regulation to include, but not limited to, gastric bypass, other bariatric surgeries, resection of small or large intestine leading to malabsorption, gastric resection for ulcers or cancer, and esophageal resection
* Intention to follow recommended program and complete outcome assessments and requested self-monitoring.
* Obtain a physician's clearance form
Effect of Sustained-Release Cetylpyridinium Chloride Varnish on Streptococcus Mutans and Lactobacillus in Orthodontic Patients

The purpose of the study is to was to evaluate the anti bacterial efficacy of sustain-release Cetylpyridinium chloride varnish on orthodontic patients.


Eligibility Criteria:
Exclusion Criteria:

* Children under 12y old
Effectiveness of Recombinant Human Growth Hormone Therapy for Children With PMS

In summary, this piot study with 6 participants shown that recombinant human growth hormone (rhGH) has a positive effect on the treatment with PMS. In addition, This study indicated that rhGH can improve PMS symptoms via increase the level of serum insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3). RhGH may be low cost, more accessible, alternative treatment for PMS.

Compared with the placebo, rhGH treatment significantly decreased the total scores and subscale scores of GDS (P \<0.05), while the total scores and subscale scores of SC-ABC significantly decreased (P \< 0.05) following three-months rhGH treatment. The similar results were also observed in comparison with baseline. Compared with the baseline, the level of serum IGF-1 and IGFBP-3 increased significantly (P \< 0.05) following three-months rhGH treatment, while the placebo group had no significant impact on serum IGF-1 and IGFBP-3 (P \> 0.05). One participant developed skin allergy the day after the first rhGH treatment, which were resolved later.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PMS aged from 1years to 5 years

Exclusion Criteria:

- active or suspected tumour, intracranial hypertension, chronic kidney disease, acute proliferative or severe nonproliferative diabetic retinopathy, allergy to rhGH or severe comorbidity
An End-to-end System for Assessment and Intervention of Frailty

The study aims to evaluate the feasibility and effectiveness of using SAIF (an end-to-end System for Assessment and Intervention of Frailty) to reduce the risk and delay the progress of physical frailty.

SAIF is a personalised, community-based system for both assessment and intervention of frailty. It comprises of 8 modules categorised into

1. Interface: virtual nurse and caregiver gateway
2. Assessment: computerised screening using Fried Frailty Phenotype (FFP) and FRAIL instruments, Gamified Walking While Talking to assess frailty status and predictive analytics to predict participant's frailty risk
3. Intervention: Physical exercise kiosks (Cycling and Taichi) incorporated with games, polypharmacy management and nutrition recommendation

A total of 105 eligible community-dwelling older adults were recruited and randomised either to control arm or intervention arm using a single-consent Zelen's design. Allocation concealment was achieved using permutated block randomisation; both research assistant and participant were blinded to randomisation list during enrolment.

All participants completed baseline assessment and subsequent follow-up assessments (2-month, 4-month and 7-month). Additionally, participants in the intervention arm began SAIF interaction for a period of 4 months upon completion of their baseline assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 60 and above
2. CFS 4 or 5 / CFS 3 with FRAIL score at least 1 / CFS 3 with FPQ score at least 1
3. Ambulate for at least 10m without walking aid
4. English and/or Mandarin speaking

Exclusion Criteria:

1. Known diagnosis of dementia or CMMSE score \<19
2. Parkinson's disease
3. Hip surgery within the last 6 months
4. Presence of end-stage organ failure, symptomatic heart conditions or COPD
5. Active arthritis
6. Hospitalisation within the last 1 month
7. Participants who are unable to provide consent
Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

The aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.


Eligibility Criteria:
Inclusion Criteria:

* DBS in one of the defined nuclei of interest during the period of the study
* Be willing and able to give written and oral informed consent
* Ability to complete all required study procedures including travelling to Mayo Clinic and staying overnight
* All women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study. This includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (IUD) or abstinence.

Exclusion Criteria:

* Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
* Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate
* Pregnancy test positive.
Comparative Effects of Paraffin Bath Therapy and ESWT in Patients With De Quervain Tenosynovitis

There is no study in the literature comparing both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) in the treatment of patients with De Quervain Tenosynovitis. The aim of this study is performing this comparison.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Meeting De Quervain diagnostic criteria
* Not having applied any physical therapy modality to the hand-wrist in the last 1 month
* Not using pain medication in the last 1 month,
* Not using local anesthetics or steroid injections on the hand-wrist in the last 3 months
* Have received written consent to participate in the study, and have come to the last control at the 6th week.

Exclusion Criteria:

* Neurological diseases (especially neuropathies),
* Malignancy,
* Rheumatological diseases
* Pregnancy
* History of hand/wrist fracture or surgery
* Hand/wrist trauma in the last 1 month
* Coagulation disorder diseases
Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study

The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection initiative, first compiling data on the current treatment of post myocardial infarction patients (screening-log) and then, prospectively evaluating only those patients being prescribed Omacor as part of their standard secondary prevention treatment. The aim is to observe the Omacor cohort of patients for a period of 12 months, collecting long term observational data as clinical and patient-reported outcomes, especially, but not exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or interventions will be mandated. Only results from routinely performed tests, labs, procedures and/or interventions will be collected if available.


Eligibility Criteria:
Inclusion Criteria

* Male and female patients, from the screening-log, having been prescribed prior to their inclusion in the study Omega-3-fatty-acid ethyl esters (Omacor) as adjuvant treatment in secondary prevention after their myocardial infarction, in addition to standard therapy \[e.g. statins, antiplatelet medicinal products, beta blockers, Angiotensine Converting Enzyme (ACE) inhibitors/Angiotensine II Receptor Blockers (ARBs), etc\].

Exclusion Criteria

* Omega-3-fatty-acid ethyl esters (Omacor) approved contra-indication as per the labeling information in participating countries
Impairments of Oral Language in Mobius Syndrome

The Möbius syndrome constitutes a congenital disorder classically caused by genetic and environmental factors. The clinical manifestations include lesion of the facial and abducens nerves associated with limb malformations specially club foot. The speech-language manifestations include compromise of oral and deglutition, speech and language functions, secondary to cranial nerves lesions and mental retardation. The language compromise in this disorder is still not well known. In this way, the main objective of this study is to characterize the oral language in a population of fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará. The present work is a descriptive study of a cross-sectional design conducted from February to December/2002, using a clinical evaluation of language components including morphology, syntax, semantics and pragmatics. The investigators identified exclusive speech involvement in 20,0% of the subjects, language disturbance in 46,7%, speech and language disturbance in 13,3% and oral language involvement in 26,7%. The investigators conclude that the language disturbance in the Möbius syndrome presents with a variable compromise of all oral language components. The delay in linguistical development, incomprehensive speech and the deficit of constructions of sentences and narrations are constant.

In this way, the main objective of this study is to characterize the oral language in a population of fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará. The present work is a descriptive study of a cross-sectional design conducted from February to December/2002, using a clinical evaluation of language components including morphology, syntax, semantics and pragmatics.

Eligibility Criteria:
Inclusion Criteria:

* Möbius syndrome
* Age ranging from two to thirteen years old.

Exclusion Criteria:

* Others diseases with impact in oral language.
Measuring Pain and Hydration After Tonsillectomy

Pain after tonsillectomy remains a key barrier during the post operative period. The published return rate to the emergency department for hydration and pain control is approximately 4%. If we can demonstrate decreased pain or decreased visits to the emergency department post tonsillectomy, patient experiences will be improved and health care dollars spent will be decreased. We will attempt to improve hydration status by encouraging consumption of a novel isotonic hydration solution that is currently commercially available.

Our study hypothesis is that patients provided an isotonic hydration solution and instructions on avoiding dehydration post operatively will have improved pain control and decreased emergency department visits.

Improvement in hydration status has the potential of decreasing emergency room visits and subsequent decrease in spending of healthcare dollars. Additional benefits of post-operative hydration may include decrease in pain and decrease in post-operative bleeding rates.

A new isotonic hydration solution with an improved flavor profile (Hoist®) has recently become commercially available. Itis very similar to that of Pedialyte, a commonly used rehydration solution. Pedialyte was designed for rehydration of infants and small children. It has a taste that is not acceptable to many adults and older children.

This study will implement the use of Hoist as suitable rehydration solution. This study is designed to define the relationship between improvement of patient's hydration through provision of a rehydration solution during the post operative period and decrease in complications requiring return to the emergency room, including dehydration and bleeding, as well as improvement in overall pain control.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing tonsillectomy
* Patients undergoing tonsillectomy with adenoidectomy

Exclusion Criteria:

* Patients on anticoagulants
* Patients younger than 3 years old
* Patients with chronic pain syndrome
Self Management and Recovery Training (SMART) Recovery Study

This study identifies whether and how online support groups may work to confer therapeutic benefits onto its participants.

Online support groups (e.g., SMART Recovery) are an increasingly common non-professional intervention for people who engage in problematic alcohol use, but it is unclear how they help participants reduce their use.

The primary objective of this study is to determine whether alcohol use decreases more after attending online SMART Recovery psychoeducational support group meetings, as compared to receiving psychoeducational content alone.

The secondary objectives are to identify whether variables such as quality of life and recovery capital (i.e., resources to support recovery from addiction) relate to treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Is fluent in English and have a 6th grade reading level or higher
* AUDIT score of ≥8
* Has some desire to cut down or quit their alcohol use
* Has access to a phone or computer with reliable internet connection, a functional microphone and camera
* Is willing to consent to being audio and video recorded during the meetings

Exclusion Criteria:

* Is not able to commit to the 6 weeks of intervention and the one- and three-month follow-up.
* Has vulnerable population status (e.g., pregnant people, prisoners)
Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery.

Eligible patients were randomized to a cardiopulmonary rehabilitation program (Rehab; n = 10) or to usual care (Control; n = 10). The randomization was done by the Graphpad StatMate computerized program. Those patients assigned to Control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (CPM), but were not exposed to any specific respiratory or motor physical intervention. Those randomized to Rehab received the same medical and nursing care, but followed a structured physical therapy program twice a day.

Eligibility Criteria:
Inclusion Criteria:

* Previous history of more than one vessel coronary artery disease
* Lifelong abstinence from tobacco
* Formal indication for CABG

Exclusion Criteria:

* Patients older than 75 years of age
* Chronic renal failure (dialysis for more than 3 months)
* Unstable angina in the 48 hours prior to CABG
* Moderate or severe valve disease
* Complex cardiac arrhythmia's
* Stroke
* Inability to exercise the lower limbs
* Previous pulmonary disease (forced vital capacity \[FVC\] \< 80% of predicted and/or forced expiratory volume in 1 s \[FEV1\] \< 70% of predicted)
* Previous history of asthma.
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis

SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL \<400 copies/mL) 26 weeks after enrolment.

In this randomized controlled trial (RCT) two different, guideline-approved algorithms for antiretroviral therapy (ART) initiation in people living with HIV (PLHIV) with presumptive Tuberculosis (TB), but no signs of central nervous system (CNS) disease will be compared. In one arm, same-day initiation (SDI) of ART will be applied ("ART first") for all participants independent of the status or results of initial TB investigations. In the other arm, an approach with deferral of ART initiation until TB is excluded or confirmed and TB treatment initiated will be applied ("TB results first"). The direct comparison of the two approaches in a pragmatic, two-country RCT conducted in a representative high-prevalence setting will provide evidence on the open question of optimal timing of ART initiation in the large subgroup of PLHIV with presumptive TB outside the CNS.

Eligibility Criteria:
Inclusion Criteria:

* 12 years or older
* HIV-positive
* Not taking ART (naïve or reported no ART intake since 90 days or more)
* Presenting with one or more TB symptoms according to W4SS
* Unknown TB status
* Planning to continue care at the study facility for at least 30 weeks
* Willing and able to consent (age 18 years or older) or assent with guardian consent (age 12 to 17 years)

Exclusion Criteria:

* Medical condition requiring admission or referral to a higher level health facility at enrolment
* Symptoms or clinical signs suggestive for diseases of the CNS
* Positive cryptococcal antigen test (CrAg)
* Reporting to be pregnant
* Taking TB treatment, TB preventive therapy (TPT) or treatment against cryptococcal meningitis
Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Neurobehavior as Breast-Feeding Predictors

Presently, the literature addressing the relationship between epidural analgesia and likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals, administered prior to vaginal delivery of a full-term, healthy neonate, significantly decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum. One proposed mechanism is that analgesics, by decreasing maternal pain during labor, decrease maternal endorphin production and result in the transmission of lower endorphin levels to the neonate during breast-feeding. Lower endorphin levels, in turn, may render the neonate less likely to suckle optimally. Other studies have found that epidural analgesia does not significantly decrease lactation success when used during the vaginal delivery of a full-term, healthy neonate.

Although most studies to date have compared the breast-feeding success of epidural recipients and non-recipients at various points postpartum, they do not specifically note whether deficient feeding behaviors on the part of the infant contribute to failed breast-feeding. The present study uses the LATCH assessment tool to score the infant's ability to latch onto the breast and the presence of audible swallowing, as well as the mother's level of physical comfort with breast feeding, whether she can successfully position the infant for feeding on her own, and whether her nipples are inverted, everted, or flat. Thus, the LATCH assessment enables the separation of multiple factors that may contribute to breast-feeding failure. A multivariate regression analysis will determine how strongly the probability of breast-feeding at hospital discharge correlates with epidural duration, LATCH scores, and beta-endorphin concentrations in colostrum.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Vaginal delivery of a single live neonate at MetroHealth Medical Center's Main Campus

Exclusion Criteria:

* Delivery by Caesarean section
* Admission to the NICU following delivery
* Neonatal or maternal pathologies that would obviously impede normal breast-feeding activity
Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy.

Objectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay.

A total of 100 children presenting with acute appendicitis were included in this study, In group A, patients were undergone laparoscopic appendectomy.

In group B, patients were undergone open appendectomy. During surgery, operative time was noted. After surgery, patients were shifted to surgical wards and were followed-up there till discharge. Patients were followed regularly by the researcher for mean post-operative pain at 24 hours. At discharge, hospital stay was noted. Then patients followed up in outpatient department for 10 days for any evidence of wound infection.

Eligibility Criteria:
Inclusion Criteria:

1. Children of age 7-12 years of either gender diagnosed as acute appendicitis
2. pediatric appendicitis score \>4

Exclusion Criteria:

1. Children with comorbidities,
2. Perforated appendix
3. Appendicular mass (on clinical examination). -
Patient Support During Surgical Abortion

This study will be a non-blinded randomized controlled trial (RCT) of women presenting for abortion at \<13 6/7 weeks. Women will be randomized either to receive support by a trained abortion doula (intervention) or to have standard procedure (control) during the abortion procedure. The investigators hypothesize that women who receive doula support during a first trimester abortion will report less pain during the abortion procedure compared to women who do not receive abortion doula support.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Gestational age by sonogram \< 13 6/7 weeks gestation
* Desires pregnancy termination
* Ability to understand the study and give informed consent
* Ability to read and comprehend informed consent document in English

Exclusion Criteria:

* Aged \< 18 years
* Gestational age by sonogram \> 13 6/7 weeks gestation
* Inability to understand the study and give informed consent
* Inability to read and comprehend informed consent document in English