cyrilzakka/clinical-trials huggingface dataset:
Educational Nutritional Intervention for Adolescents

Randomized controlled trial by conglomerates whose objective is to evaluate the effectiveness of an educational nutritional intervention, based on the Social Cognitive Theory, for the increase in the consumption of vegetables and fruits and the decrease in the consumption of ultra-processed foods in adolescent high school students, in the University of Guadalajara, in Guadalajara, Jalisco.

Background: Adolescent nutrition is of vital importance for their growth and development, at this stage eating habits for adult life are consolidated. However, currently the eating habits of adolescents are mainly characterized by a high consumption of ultra-processed foods and a low consumption of vegetables and fruits. Effective nutritional interventions focused on this age group can contribute to the prevention of adolescent diseases at the current stage and in later stages.

Objective: To evaluate the efficacy of an educational nutritional intervention, based on the Social Cognitive Theory, to increase the consumption of vegetables and fruits and decrease the consumption of ultra-processed foods, in adolescent high school students at the University of Guadalajara (UDG), in Guadalajara, Jalisco, in the year 2022.

Material and methods: Randomized controlled trial by conglomerates, students from the school groups chosen at random, from two high schools (one as a control group and another intervention) also chosen at random will be included. Adolescents who agree to participate will complete pre- and post-intervention assessments on fruit and vegetable consumption and ultra-processed foods. A multilevel analysis will be used to compare post-intervention variables between groups.

Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in the included high schools (1st to 6th semester, morning and evening shift)
* That they agree to participate and complete the assent and informed consent form

Exclusion Criteria:

* Students who do not wish to participate
Gastrointestinal Microflora and Serum Metabolomics in Patients With Pancreatic Cancer and Chronic Pancreatitis

The investigators plan to collect throat swabs, saliva, feces and serum samples from pancreatic cancer patients, chronic pancreatitis patients and healthy people and clarify the characteristics of oral flora and serum metabolome of pancreatic cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1.Pathologic diagnosis of pancreatic ductal adenocarcinoma；Diagnosis of CP defined as having obvious morphological features of CP (i.e., the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)；Other benign disease populations without pancreatic lesions.

Exclusion Criteria:

1. Pregnant women.
2. Patients with coagulation disorders who are unable to undergo blood tests.
3. Have a history of using antibiotics or probiotics within the past 3 months.
Spectral-domain Optical Coherence Tomography of the Eye

An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. However, the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative, observational study aims to evaluate the imaging quality and diagnostic performance of two commercially available SD-OCT machines for both the anterior and posterior segment of the eye.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 and older
* Normal eyes or
* Eyes with corneal disease:

Subjects that have any of the following conditions

1. Corneal dystrophy or degeneration
2. Corneal scarring
3. Corneal ulcer
4. Corneal injury
5. Keratoconus
6. Patients who had undergone corneal surgery
7. Patients with other corneal disease or - Eyes with retinal disease:

Subjects that have any of the following conditions:

1. Diabetic macular edema
2. Cystoid macular edema
3. Age related macular degeneration
4. Retinal vascular disorders (e.g. retinal artery occlusion)
5. Epiretinal membrane
6. Choroidal nevus
7. Macular hole
8. Patients who had undergone retinal surgery
9. Patients with other retinal disease or

   * Eyes with glaucoma
   * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.

AND

- Written informed consent prior to recruitment

Exclusion Criteria:

Any of the following will exclude a subject from the study:

* Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
* Pregnancy (pregnancy test will be taken in women of reproductive age before enrolment into the trial)
Pennington Center Longitudinal Study (PCLS)

The purpose of this study is to develop a cohort of volunteers that can be studied and followed up into the future for changes in health behaviors and development of health problems.

The PCLS represents an effort to utilize the data collected over the last twenty years during the clinical research studies conducted at Pennington Biomedical Research Center. A cohort will be developed and used for cross-sectional analyses, as well as followed prospectively for the development of a variety of health-related outcomes. Several data sources from the PBRC clinical database will be used to establish the PCLS database, including screening, archive and study-specific data. The only protocol specific to the PCLS study is the collection of blood sample for risk factor determination and storage in the PBRC archive bank, only to be invoked in cases where studies do not include a blood draw as part of their protocol.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* volunteer to Participate

Exclusion Criteria:

* younger than 18 years
* Pregnant
Evaluation of Safer Sex Intervention (SSI)

The purpose of the study is to determine the impact of the offer to participate in Safer Sex Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and frequency of sex) six months after the end of treatment.

The Policy \& Research Group (PRG) will be evaluating the Safer Sex Intervention (SSI). The Safer Sex Intervention is based in Social Cognitive Theory, the Transtheoretical Model of Behavior Change, and motivational interviewing. Coupled with skill-building exercises, the intervention is intended to increase knowledge related to risk and safe-sex behaviors, to increase awareness of risk and need for behavior change, to help build self-efficacy to engage in safe-sex behaviors, and, ultimately, to motivate participants to engage in and maintain safe sex practices. The intervention is meant to be delivered in four, one-on-one sessions over the course of six months. Each session is to be conducted in a private setting by a female health educator trained in motivational interviewing and Safer Sex Intervention. The initial or primary intervention session should take approximately 30 to 50 minutes. Subsequent "booster sessions" delivered 1, 3, and 6 months following the initial session are to take 10 to 30 minutes. Booster sessions are intended to sustain any resulting behavior change. The control (counterfactual) condition, Female Sexual Health, was developed specifically for use in this study; it consists of a 30-minute PowerPoint presentation, intended to be delivered in one face-to-face session that provides information about reproductive anatomy and STIs. After the presentation, participants receive free condoms. This is the only session for the control condition; there are no booster sessions. Though there were some variations in consent requirements across sites, there were no differences in the recruitment process between the treatment and control groups. All eligible individuals who provided the proper consent to participate were randomized and enrolled into the study at the time they attended their first scheduled study session. Data were collected via self-administered questionnaires that were scheduled at baseline and six months post treatment (12 months after baseline). The study took place in New Orleans, Louisiana, at five clinics that served young women between the ages of 14 and 19.

Eligibility Criteria:
Inclusion Criteria:

Between the ages of 14-19 Had engaged in sex with a male in the three months prior to enrollment Provide parental consent (if under age 18) and participant assent to participate in the study.

Exclusion Criteria:

Not have previously participated in any of the following pregnancy/HIV prevention programs:

* 4 Real Health
* Becoming a Responsible Teen (BART)
* Healthy Living
* Staying Mature and Responsible Towards Sex (SMARTS)
* Sisters Informing Healthy Living and Empowering (SIHLE)
* Project AIM
* Making Proud Choices
* Be Proud Be Responsible
* Focus on Your Future
IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients

The purpose of the study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called "ocular hypertension" (OHT). In a previous study, it has been shown that OHT patients who progress to glaucoma (converters) have at baseline and prior to any conversion, IOP patterns that more closely resemble those of established early primary open-angle glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer to those of healthy control subjects. The study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OHT (IOP \>21 mmHg on 2 consecutive visits) in the study eye
* No IOP-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (SD0) and throughout the study
* Aged ≥ 18 years, of either sex
* Not more than 6 diopters spherical equivalent in the study eye
* Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye
* History of ocular surgery on the study eye (except cataract extraction)
* History of laser treatment on the study eye
* Corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation
* Severe dry eye syndrome
* Subjects with irregular sleep schedules
* Subjects who are current smokers
* Subjects with allergy to corneal anesthetic
* Subjects with contraindications for silicone contact lens wear
* Subjects not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
* Any other contra-indication listed in the TF user manual
Clinical Application and Mechanism of Cord Blood Mononuclear Cells in the Treatment of Ischemic Bowel Disease

Ischemic bowel disease, also known as ischemic bowel disease (IBD), is a type of disease that causes the blood supply to a certain intestinal segment to be reduced or stopped by various reasons such as hypovolemia, shock or recent abdominal surgery, resulting in insufficient blood supply to the intestinal wall, and causing a series of pathological changes in the intestine. Human umbilical cord blood mononuclear cells (HUCB-MNC) can be economically and conveniently isolated from human cord blood. The HUCB-MNC obtained from the isolation of human umbilical cord blood contains a variety of stem cells, such as hematopoietic stem cells, endothelial stem cells, etc. A number of previous studies have confirmed that HUCB-MNC can improve the occurrence of ischemic bowel disease through immunomodulatory and tissue repair. These characteristics make HUCB-MNC a cell with great potential to treat ischemic diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age is not limited, gender is not limited. Meet the diagnostic criteria for ischemic bowel disease and clearly diagnose inpatient patients with ischemic bowel disease.
* Diagnosis and diagnosis (standard) in line with the "2011 Chinese Medical.
* Association Gerontology Branch organization of relevant experts jointly wrote the diagnosis and treatment of ischemic bowel disease in the elderly in China":

  1. Acute mesenteric ischemia (AMI): clinical manifestations are acute and severe abdominal pain, symptoms do not match the severity of signs, and signs are often not obvious. Abdominal x-ray may show "finger marks" and balloon signs. CT shows no visualization of the superior mesenteric artery or intraluminal filling defect. Arteriography is helpful in diagnosis, and intestinal mucosal pathology is dominated by ischemic changes, such as in patients with vasculitis, thrombosis, and vascular embolism.
  2. Chronic mesenteric ischemia (CMI): clinical symptoms are recurrent abdominal pain, chronic disease capacity, emaciation, no tenderness in the abdomen, and vascular murmurs can often be heard in the upper abdomen. Imaging tests such as arteriography, CTA, and MRA can help confirm the diagnosis of CMI. It is mainly based on clinical symptoms and advanced imaging tests.
  3. Ischemic colitis (IC): manifested as unexplained abdominal pain, bloody stool, diarrhea or abdominal acute abdomen, which can be diagnosed with colonoscopy and angiography if necessary.

Exclusion Criteria:

* The diagnosis does not conform to the "2011 Cases of Diagnosis and Treatment Recommendations for Ischemic Bowel Disease in the Elderly in China Jointly Written by Relevant Experts organized by the Geriatrics Branch of the Chinese Medical Association";
* Exclude those with serious diseases of other organs;
* Patients with other diseases such as gastrointestinal tumors and inflammatory bowel diseases cannot be excluded.
Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.

The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo in the treatment of patients with persistent pain who require an opioid medication for control of their pain.

Eligibility Criteria:
Inclusion Criteria:

* persistent, moderate-to-severe noncancer related pain requiring continuous analgesia for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or opioid equivalents per day for control of their persistent pain and who are willing to accept the possibility of receiving placebo during the Double-Blind Phase

Exclusion Criteria:

* Patients already receiving opioid medication at an average total daily dose greater than 40 mg of oxycodone or opioid equivalents during the last week prior to study entry.

Other protocol-specific exclusion/inclusion criteria may apply.
COVID-19 : Neutralizing Human Monoclonal Antibodies Against SARS-Cov-2

Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.

The objectives of this study are :

* To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.
* To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.
* To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient who signed the study consent form
* Convalescent patient (at least 12 days after the onset of symptoms), having been sampled at Hospices Civils de Lyon for a suspected infection with SARS-Cov-2, confirmed by PCR.

Exclusion Criteria:

* Patient treated with rituximab
* Patient treated with immunoglobulins
* Patient over 18 years old, subject to a legal protection measure (guardianship or trusteeship)
* Patient deprived of liberty
* Pregnant or lactating woman
* Patient not affiliated to a social security scheme or beneficiary of a similar scheme.
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.

Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years or older
* Patient or legal representative is able to understand and provide signed consent for the procedure
* Patient is willing and able to return for required follow-up visits
* Patient needs a total hip arthroplasty surgical procedure

Exclusion Criteria:

* Patient has an active infection
* Patient is enrolled in another similar study
* Patient has a known history of hepatitis
* Patient has a known history of HIV
* Patient has a known history of AIDs
* Patient has a known history of IV drug abuse
Usability Evaluation of Menai CPAP Masks

The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.

The study will evaluate the subjective seal, comfort, stability, usability, and humidification performance of the prototype mask systems in CPAP established patients. The performance of the prototype Menai mask systems (full face, nasal, and pillows variants) will be subjectively assessed through user questionnaires based on an 11-point Likert scale, and will be compared against Comparison masks.

The prototype masks share the same parts (cushion, frame, headgear), with the difference being that the Menai masks feature a novel vent and humidification system.

Eligibility Criteria:
Inclusion Criteria:

* Participants willing to provide written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are over 18 years of age
* Participants who have been diagnosed with OSA
* Participants who have been established on CPAP for ≥ 6 months
* Participants who are currently using the same mask type/variant as the interventional mask system to be evaluated

Exclusion Criteria:

* Participants who are not able to provide written informed consent
* Participants who are unable to comprehend written and spoken English
* Participants who are pregnant
* Participants who are unsuitable to participate in the study in the opinion of the researcher
* Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants who are not currently using the same mask type/variant as the interventional mask system to be evaluated
Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)

To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.
* A BCVA approximate Snellen equivalents, 20/40.

Exclusion Criteria:

* Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.
* Pan-retinal laser photocoagulation 3 months or less before baseline,
* Topical ocular or systemic corticosteroids administered for 30 consecutive days.
* Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),
* Use of intraocular corticosteroid implants,
* Uncontrolled glaucoma (intraocular pressure \[IOP\] 30 mmHg with medication) at the time of screening or baseline,
* iris neovascularization or neo-vascular glaucoma.
Feeding Trial in Pediatric Patients

This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.

This prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 1-13 years old with development disabilities
* Currently tolerating enteral feeding
* Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts
* Requires enteral tube feeding for at least 14 days.

Exclusion Criteria:

* Unable to access gastrointestinal tract for feeding via tube
* Other condition which contraindicates tube feeding