cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Potential Causes of Nap Modulated Tinnitus

The proposed research is a non-interventional study made to evaluate different measurements on 1 group of participants, before and after taking a nap, aiming to potentially guide future investigations on nap-modulated tinnitus to better understand this phenomenon.

The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus intensity.

1. - Background : Tinnitus is a really important concern due to its high prevalence (10% world population) and its deteriorating effects on life quality. Subjective tinnitus still remains a scientific enigma because of its partial elucidation. The limited knowledge on its causes can be partially attributed to its intrinsic heterogeneity. In questionnaires previous to this study, 34% of participants showed a characteristic symptomatology of interactions between tinnitus and their sleep : they feel their tinnitus at its maximum intensity after sleeping periods (nap and sleep). In most cases they describe a frank rise of the intensity, compared in scientific papers to the "exploding head syndrome". Therefore this study aims to determine what are the main physiopathological processes correlated to the rises of tinnitus
2. - Objectives : Estimate the correlations between tinnitus intensity changes (before and after the nap) and the number of sleep apneas. Secondary measurements are described in the outcome field.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated participant or beneficiary of a social security scheme
* Acceptation of protocol and signature of non-opposition
* Frankly nap-modulated tinnitus (increase of intensity after napping)
* Tinnitus maskable by white noise equal or inferior to 85 dB

Exclusion Criteria:

* Persons under juridic protection (guardianship or safeguard of justice)
* Clear cognitive incapacity (not understanding/nor apprehend the study tasks)
* Pregnancy or breast feeding
* Epilepsia
* Non-equilibrated chronic metabolic pathology
* Non-equilibrated psychiatric pathology
* Difficulty in napping
* Important hyperacusis
* Meniere's disease, fast fluctuating tinnitus (seconds or minutes), pulsatile tinnitus
* Any patient benefiting of a tinnitus treatment that was modified in the last 3 months
* Superficial wound, open or partially not cauterized
L-glutamine Treatment in Patients With Diverticulosis

The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4 weeks screening period to determine eligibility for study entry. At Week 0, patients who meet eligibility requirements will be given L-glutamine (15 grams, twice daily)

Eligibility Criteria:
Inclusion Criteria:

1. ≥50 years of age.
2. Uncomplicated diverticulosis confirmed by colonoscopy.
3. Colonoscopy indicates ≥5 colonic diverticula (pouches) in the descending/sigmoid colon and \< approximately10 colonic diverticula (pouches) per segment (e.g. proximal descending, distal descending, proximal sigmoid, and distal sigmoid.)
4. If the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g., barrier, birth control pills, or abstinence).
5. Patients who have given their free and written informed consent.

Exclusion Criteria:

1. Acute diverticulitis (both complicated and uncomplicated).
2. Acute colitis
3. History of inflammatory bowel disease, colon resection, polyposis syndrome, severe strictures, and perforation.
4. Active bleeding
5. More than 40 diverticula
6. Chronic renal insufficiency
7. Chronic liver disease.
8. Patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female of childbearing potential).
9. Inability to give a valid informed consent or to properly follow the protocol.
10. Patients with an active malignancy of any type, or a recent history of malignancy within the last 5 years.
11. Treated with an investigational medication/treatment within 30 days prior to the screening visit.
12. Currently enrolled in an Investigational study
13. Patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit.
14. Previous difficulty pulling or passing of scope or difficulty completing colonoscopy.
15. There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
Irish Programme for Stratified Prostate Cancer Therapy

The purpose of the trial is to investigate new clinical tests that could predict what treatments work best for certain patients with advanced prostate cancer by identifying markers and indicators present in blood and tissue which correlate with treatment response.

Prostate Cancer (PCa) is a complex disease and not all patients respond to every treatment available.

This study aims to investigate new clinical tests based on simple and routine blood tests to allow men with PCa and their doctors to choose the correct treatment for their metastatic PCa.

In this way, only men likely to respond to the specific treatment will be chosen, sparing unnecessary or prolonged treatment for those who will not respond and allowing them to avail of alternative therapies likely to have more benefit. This is termed personalised therapy.

The study will perform research on biological elements present in the blood including deoxyribonucleic acids (DNA), ribonucleic acid (RNA), protein and circulating tumour cells (CTCs) which are cancer cells that have spread beyond the prostate gland and can be found floating in the blood. Clinical data will be correlated to research findings to form conclusions on personalised therapy.

Additional optional sub studies include; magnetic resonance imaging (MRI) with a biopsy of another tumour in a different site of their body such as bone, lung or liver (metastatic biopsy), metastatic biopsy only and biopsies of the fluid of solid part of the bone. These optional components provide more detailed information on prostate cancer and how men are responding to treatment. The research results from these optional sub studies will be correlated with the research analysis from the blood samples and clinical data and will help to make treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

1. Stage 4 mPCa as confirmed by CT/MRI or by bone scan
2. Patient with visceral disease and/or bone lesions (excluding patients who only have nodal disease), who have commenced or are about to commence ADT and whose disease has not shown any evidence of castration resistance (cohort 1) Or Patient with castrate-resistant disease at time of treatment change (cohort 2)
3. Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to recruitment
4. Life expectancy of at least 6 months
5. Ability to give written informed consent obtained before any study-related procedures
6. Age ≥ 18 years and male

Exclusion Criteria:

1. Diagnosis of or treatment for another systemic malignancy within 2 years before study entry.\*
2. Any evidence of residual disease from a previously diagnosed malignancy. \*Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
Smile-Kids: Study on Complementary Feeding Transition

The importance of families in the development of infants is well documented. Previous studies found that the prevalence of overweight and obesity is growing concerns in Portugal (Padez, Fernandes, Mourão, Moreira, \& Rosado, 2004) and in the world (Ogden et al., 2014). More, there is evidence that habits acquired in early life might track into adulthood (Lien, Lytle, \& Klepp, 2001; Lytle, Seifert, Greenstein, \& McGovern, 2000; te Velde, Twisk, \& Brug, 2007). Therefore, there is a need to lock overweight and obesity in early childhood in order to contribute to health gains during the entire life cycle. The main purpose of this research is to evaluate the impact of an intervention program based on parenting skills and feeding practices, on infant's growth, development and adherence to new foods in early infancy

Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized trial and were randomly allocated to intervention and control group. Infant outcomes were performed at baseline and post-intervention and included anthropometry, dietary assessment and temperament. In addition maternal and family outcomes such as anxiety, dietary intake were also assessed at both times.

An intervention program was developed and Implemented according to two terms: educators' training with the researchers and the intervention with parents and infants developed by trained educators. The training program was developed between December 2013 and February 2014, according to the topics of healthy eating and nutrition and development of the infant. The control group received the standard care.

It is expected that this intervention program is able to promote healthy feeding practices to parents and nursery teachers. The results will be disseminated to the stakeholders and policymakers that work closely to the topic of this study. This will include papers' publication, participation in national and international meetings, contributing to the advance of research in this health area.


Eligibility Criteria:
Inclusion Criteria:

* Infants with 4-12 months

Exclusion Criteria:

* Infants with disability
Comparison of Aerobic Training and Circuit Training in Healthy Children

Childhood obesity is a growing concern, with potential consequences for long-term health. The number of obese children has increased more than tenfold in the last forty years. Over the course of their lifetimes, more and more young people worldwide will be exposed to obesity, which will hasten the onset of type 2 diabetes, fatty liver, and cardiovascular problems. Promoting physical activity in children is crucial for maintaining a healthy weight and improving overall well-being. Less than 30% of kids and teenagers worldwide fulfill the recommended daily minimum of 60 minutes of moderate to intense physical activity. Since that most children and adolescents spend a significant amount of time traveling to and from school or attending school, schools may be the best places for interventions. This project will investigate the effectiveness of two common exercise approaches, aerobic training and circuit training, on body mass index (BMI), physical fitness, and quality of life in healthy children.

A randomized controlled trial will be conducted, recruiting healthy children within a specific age range 8-12. This study will be conducted in the Leader's Lyceum School.Two experimental groups will be made. Participants will be randomly assigned to either an aerobic training group or a circuit training group. Non-probability convenient sampling technique will be used. The study will include the children from age 8 to 12, both genders, healthy children. Both programs will be implemented for a set duration of 12 weeks, with specific parameters regarding intensity, duration, and exercise types. The project will assess changes in BMI, physical fitness components (e.g., cardiovascular endurance, muscular strength, flexibility), and quality of life through validated measures, including Pediatric Quality of Life Generic Score 4.0 (PedsQL), Physical Fitness Test, Presidential Fitness test and BMI.


Eligibility Criteria:
Inclusion Criteria:

* ⦁ School Age Children from age 7-12 years

  * Both Genders, Male and Female
  * Healthy and fit children
  * Interventions should be given inside the premises of school
  * Children with normal range BMI: 13.3-24.1
  * Children with presidential fitness score at or above the 85th percentile
  * Children with Quality of Life score: minimum 50

Exclusion Criteria:

* ⦁ Any Children havig any mental condition: Depession or Anxiety

  * Visual, vestibular, or balance disorders in the preceding six months
  * Children with any orthotic devices
  * Children undertaking any previous aerobic or circuit training
  * Refusal of any child or parent to participate
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

The purpose of this study is to determine if low bone mineral density (a measurement of how thick and strong bones are) improves in adults with HIV infection who switch their HIV medication tenofovir to another HIV medication raltegravir.

Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic patients switching from ART including tenofovir disoproxil fumarate (TDF) and a ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.


Eligibility Criteria:
Inclusion Criteria:

1. provision of written, informed consent
2. HIV-infected adults at least 18 years of age
3. receiving stable ART including TDF and a r/PI for the previous 6 months
4. no prior PI genotypic resistance or known replication of HIV in patients receiving a PI
5. plasma HIV RNA \< 50 copies/ml for at least the previous 3 months
6. spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA)

   Exclusion Criteria:
7. participation in any other clinical trial (unless approved by the study PI)
8. use of TDF for previously active chronic hepatitis B infection
9. receiving or requiring therapy for low BMD (including prior fragility fracture)
10. using oral corticosteroids or inhaled fluticasone
11. virological failure on, or intolerance to, RAL
12. contra-indication to RAL therapy (see appendix 2)
13. breast-feeding
14. pregnancy
15. secondary, endocrinological cause of low BMD:25-hydroxy vitamin D deficiency, hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone \> 25% below lower limit of reference range and/or luteinizing hormone \> 2 x upper limit of normal (ULN),untreated hypothyroidism or hyperparathyroidism according to local reference ranges
Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

OBJECTIVES: I. Compare the efficacy of pelvic node resection vs. bilateral groin and pelvic node irradiation for invasive squamous cell carcinoma of the vulva in patients having positive groin nodes.

OUTLINE: Randomized study. Arm I: Surgery. Deep pelvic node dissection on sides containing positive nodes only. Arm II: Radiotherapy. Megavoltage (1 MeV or greater) to bilateral groin and pelvic nodes.

PROJECTED ACCRUAL: Anticipated annual accrual is approximately 200 patients, with an active phase estimated at 2.5-3 years. Protocol closed July 1984.

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria
A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants

This is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995

YH35995 is being developed as a treatment for the neurological symptoms of Gaucher Disease type 3. This study is a first-in-human (FIH), phase 1, randomized, double-blind, placebo-controlled study of YH35995, which consists of two parts. In Part A (SAD), single ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD. In Part B (MAD), multiple ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD.

Eligibility Criteria:
Inclusion Criteria:

* Male between the ages of 19 and 45 at the time of providing written consent
* Participants who weigh at least 50 kg at screening and have a body mass index (BMI) of at least 18.0 kg/m2 and less than 30 kg/m2
* Participants who have been fully informed about and fully understand this study, have voluntarily decided to participate, and have agreed in writing to comply with the guidelines of the study during the duration of the study

Exclusion Criteria:

* Participation in a bioequivalence trial or any other clinical trials within 6 months prior to the first scheduled dose of the IP (within 1 month of the first scheduled dose for participants who have taken part in a dietary supplement clinical trial)
* Individuals with clinically significant abnormal results that do not match any other inclusion/exclusion criteria, as determined by the principal investigator and the delegated persons(investigator)
* Individuals who are unwilling or unable to comply with the participant guidelines described in this protocol
ORIGIN® vs. VANGUARD® PS Observational Study

The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.

This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.

Eligibility Criteria:
Inclusion/exclusion criteria
Study of ZIO-101 in Multiple Myeloma

The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma


Eligibility Criteria:
Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.
The Effects of the Swiss Ball on Cerebral Vascular Accident

The objective of this study was to investigate the effects of the Swiss ball on patients with hemiplegia due to CVA.

The Cerebral Vascular Accident (CVA) is a neurological deficit, which may be transitory or definite, leading to motor, psychological and social alterations. It's the third cause of death in the industrialized world, of which 90% of the survivors have some residual deficit and 30% become disabled. The objective of this study was to investigate the effects of the Swiss ball on patients with hemiplegia due to CVA. An intervening and controlled study was conducted on 12 patients of both genders and over 50 years old with chronic hemiplegia, all undergoing treatment at the Beneficent Rehabilitation Association of Ceará. The patients in the experimental group (EG) underwent treatment with the Swiss ball added to conventional physical therapy and the control group (CG) went through conventional physiotherapy sessions. The treatment was done twice a week, consisting of 14 sessions altogether. The data were collected in an evaluation form at the beginning and at the end of the treatment. Most patients were found to be males; they had typical walking ability, tonus, and posture of chronic hemiplegia patients. The patients in the experimental group showed significantly greater muscular strength on the lower limbs than the control group (p \< 0,05, Student t test), however, the same did not happen in the case of the other parameters, such as strength on the upper limbs, coordination, and balance. We can conclude that the treatment with the Swiss ball can promote increased strength, which will allow for a more efficient recovery in the studied population.

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegia due to CVA
* In physiotherapy treatment
* Acceptance in join the research

Exclusion Criteria:

* Less then 6 months of diagnostic
Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

Control of diarrhoeal disease requires a comprehensive package of preventive and curative interventions. in Zambia, the Programme for Awareness and Elimination of Diarrhoea (PAED) aims to reduce child deaths by combating diarrhoea in Lusaka province, Zambia. The behaviour change component of the PAED programme seeks to change behaviours important for diarrhoea prevention (handwashing with soap and exclusive breastfeeding) and improved treatment outcomes (use of oral rehydration solution (ORS) and zinc in home management of child diarrhoea).

The study aims to evaluate the feasibility of implementing a multiple behaviour change community programme to tackle diarrhoeal disease in children under-five and to assess the impact of this programme on practice of the target behaviours by caregivers of children under-five. The research questions will be answered through a a two-arm cluster-randomised trial (eight clusters per study arm).

Specific objectives of the study are as follows:

* Evaluate the effect of the programme on ORS and zinc uptake and usage, exclusive breastfeeding and handwashing with soap (primary objective)
* Determine the extent to which the programme has positively influenced key mediating factors that determine behaviour (i.e. social norms, physical infrastructure, attitudes, and disease and treatment perceptions)
* Investigate which components of the community programme (i.e. specific activities in clinics, community events etc.) are linked to the success of the programme (most acceptable, feasible etc) and in what context

  o Validate model of intervention theory that explains how the context and mechanisms of the intervention interact to produce behavioural outcomes
* Determine which target populations are more likely to uptake the desired behaviours and identify the supporting factors that might explain this
* Conduct process evaluation to assess i) if the programme has been implemented as intended, ii) if the desired levels of reach and coverage have been achieved, iii) costs of implementation, iv) the extent to which changes in behaviour are likely to be due to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* caregiver with child under six months (for assessment of handwashing and exclusive breastfeeding outcomes - healthy volunteers)
* caregiver with child under five years with current or recent (last 7 days) diarrhoea (for assessment of ORS and zinc outcomes)

Exclusion Criteria:

* Not resident in study area