cyrilzakka/clinical-trials huggingface dataset:
Lactose Intolerance in Infants With Gastrointestinal Disturbances

This study enrolled thirty infants who presented by GIT symptoms and their CoMiSS was ≥ 12. The patients were assessed upon presentation, after 2 weeks of receiving lactose free diet regimen and 2 weeks after rechallenging them with lactose. Assessments of infants included anthropometric measurements, CoMiSS estimation, Neonatal/Infant Pain Scale (NIPS) and pediatric quality of life assessment (Peds QL). The study aims to detect the frequency of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA) and validate of this score to be used as a screening tool for LI in infants.


Eligibility Criteria:
Inclusion Criteria:

* Artificially fed infants.
* Presented with GIT symptoms such as vomiting, diarrhea, abdominal pain, discomfort and distention.
* Cow's Milk-related Symptom Score (CoMiSS) of 12 or higher.

Exclusion Criteria:

* Infants with positive family history of Cow's milk protein allergy CMPA.
* Any allergic diseases.
* History of anaphylaxis.
* Atopic dermatitis, swelling of lips or eyelids, urticaria or wheezy chest.
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents

To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.

The goal for sub-study 4 is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs. For this sub-study we will further develop, expand, and refine the smokeSCREEN game and increase the game's reach on a national platform. The study will conduct the proposed evaluation by: working with game developers to develop a web- based version of the game, creating a pre-post survey to measure the effect of the game and building that into the smokeSCREEN game to anonymously collect information on players' knowledge and beliefs around tobacco products, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.

Eligibility Criteria:
Inclusion Criteria:

* must be able and willing to sit at a computer or mobile device for 45-60 minutes per session to play the game and answer questions before and after playing video game.
* be enrolled in a youth program that we have a partnership with

Exclusion Criteria:

* up to the discretion of the study team
Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma

Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .

Eligibility Criteria:
Inclusion Criteria:

1. Middle rectum adenocarcinoma Tumor(T)x Node (N)+ or T3 /T4 N0 or N+
2. Classification done on pelvic Magnetic Resonance Imaging (MRI) and rectal ultrasonography
3. Age ≥ 18
4. No contraindication to treatment with capecitabine
5. Able to receive radiotherapy 50 Grays in 5 weeks
6. No contraindication for surgery after chemoradiotherapy which will be 8 to 10 weeks after completion of chemoradiotherapy
7. Patient or legal representative provided with information and signature of informed consent

Exclusion Criteria:

1. High rectum adenocarcinoma
2. Contraindication to rectal biopsy: including anti-coagulants or anti-platelet agents (vitamin K antagonists, clopidogrel, aspirin \> 160 grams) that cannot be interrupted
3. Pregnant woman or breastfeeding
4. Persons deprived of their liberty, or under guardianship
5. Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.
6. Patient already included in another therapeutic trial with an experimental medication during the realization of protocol biopsies and surgery
7. Patient not covered by health insurance
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075

This pilot study examines the feasibility and acceptability of transitioning office-based buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from this study will inform the development of a future multi-site randomized clinical trial.

The overall objective of this study is to explore the feasibility of transitioning the care of adult patients with opioid use disorder (OUD) who receive office-based buprenorphine treatment (OBBT) from physicians to pharmacists. Physicians will induce buprenorphine treatment and complete the stabilization phase before referring patients to pharmacists for the management of monthly maintenance visits. This study will assess the feasibility and acceptability of a collaborative care model between physician and pharmacist by measuring recruitment rate, treatment retention rate, treatment compliance rate, and participants' substance use. Other assessments measured will include treatment fidelity, participant, physician, and pharmacist satisfaction with OUD care, participant safety, and the pharmacists' use of electronic health records and the Prescription Drug Monitoring Program.

Eligibility Criteria:
Inclusion Criteria:

* Be adults aged 18 years or older.
* If female, use adequate birth control methods.
* Meet DSM-5 criteria for past-year OUD and have completed buprenorphine induction for OUD.
* Have expressed the intention to receive maintenance (≥6 months) buprenorphine treatment.
* Be willing to receive pharmacist administered buprenorphine maintenance treatment
* Be willing and able to provide written informed consent and HIPAA authorization.
* Be able to read and communicate in English.
* Be able to comply with buprenorphine treatment policies.

Exclusion Criteria:

* Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
* Have known allergy or hypersensitivity to buprenorphine, naloxone, or other components of the buprenorphine/naloxone formulation.
* Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times the upper limit of normal on screening phlebotomy performed within 60 days prior to the date of the last stabilization visit.
* Have chronic pain requiring ongoing pain management with opioid analgesics.
* Pending legal action or other reasons that might prevent an individual from completing the study (i.e., unable to complete 6 months of pharmacy-based OUD management).
* Pregnant or breastfeeding at the time of screening.
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria

The current project aims to improve the well-being of trans and nonbinary (TNB) individuals through an online intervention (Trans Care) targeting the reduction of symptoms of gender dysphoria. The Trans Care intervention will involve the creation of an online intervention comprised of eight modules intended to reduce symptoms of gender dysphoria, increase active coping, and improve the well-being of TNB individuals. Aim 1 is a feasibility and acceptability study of the proposed intervention and will enroll 100 TNB participants to provide feedback to inform a follow-up randomized controlled trial.

The overall purpose of this project is to create a free intervention that can be disseminated widely throughout TNB communities to improve well-being in an easy, accessible way. Development and execution of the Trans Care intervention involves two primary aims:

* Aim 1) Feasibility and acceptability analysis (FAA) \[represented by this study record\]
* Aim 2) A pilot randomized controlled trial (RCT) of Trans Care's efficacy \[to be registered to a separate study record\]

Aim 1 involves qualitative and quantitative feedback regarding the content of the Trans Care intervention modules, impact on TNB participants well-being, and feasibility and acceptability of Trans Care intervention. Results from the FAA study will then be analyzed and presented to our community partners who will help us develop modifications to Trans Care to increase its efficacy and ease of use.

Aim 1 Hypotheses:

* The investigators expect that qualitative responses from participants in the FAA study overall will reflect that the Trans Care intervention was feasible and helpful. Any proposed changes from participants' qualitative responses will be incorporated into the final Trans Care intervention presented in the RCT.
* The investigators expect that participants in the FAA study will endorse high scores three scale assessment of feasibility and acceptability.

Aim 1 Endpoints:

The primary endpoint of the study is to determine if the Trans Care intervention is feasible and helpful to TNB individuals for improving their coping strategies. This will be determined through qualitative prompts and a quantitative measure of feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Identify as transgender, transsexual, nonbinary, and/or have a transgender history.
* Experience gender dysphoria.
* Time available to commit to completing a 4-5-hour online intervention and 1-2 hours to complete follow up surveys

Exclusion Criteria:

* under 18 years old
* individual does not identify as transgender, transsexual, nonbinary, and/or have a transgender history
* does not experience gender dysphoria
* is unable to commit to the time requirements of the study
* does not have access to an internet compatible device
Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery: a Randomized Controlled Trial

The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.


Eligibility Criteria:
Inclusion Criteria:

* age-related cataract patients aged between 40 to 80
* patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
* patients who plan to receive femtosecond laser-assisted cataract surgery

Exclusion Criteria:

* patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
* patients with history of ocular trauma or surgery
* patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
* patients with concurrent severe systemic diseases
* patients who lack of cooperation
Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer

The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed small-cell lung cancer
* limited disease status
* with evaluable disease
* 18 years or older
* ECOG performance status 0,1,2
* expected survival time should be 12 weeks or longer
* Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min
* Written informed consent form

Exclusion Criteria:

1. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
2. Patients with active infection requiring antibiotics
3. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
4. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
5. previous history of chemotherapy or radiotherapy
24-hour Efficacy and Ocular Surface With Talfuprost and Triple Combined Therapy

The study investigated the 24-hour efficacy and ocular surface health with preservative-free tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol fixed combination) in open-angle glaucoma patients insufficiently controlled on latanoprost monotherapy and showing signs, or symptoms of ocular surface disease with preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma patients insufficiently controlled (IOP \> 20 mm Hg) on branded, or generic latanoprost monotherapy who required further IOP reduction and who demonstrated clinical signs, or symptoms of ocular surface disease.


Eligibility Criteria:
Inclusion criteria

* Open-angle glaucoma patients (primary open-angle glaucoma, exfoliative, or pigmentary glaucoma) insufficiently controlled on branded, or generic latanoprost monotherapy (IOP \> 20 mm Hg as determined by 2 separate IOP measurements at 10:00 ± 1 hour)
* Patients with signs, or symptoms of ocular surface disease.
* Only those open-angle glaucoma subjects who, according to the opinion of the principal investigator, require further IOP reduction.
* Patients must have demonstrated at least 20% IOP reduction at 10:00 (± 1 hour) and who are treated with branded, or generic latanoprost monotherapy for at least 3 months.
* Only subjects with open-angle glaucoma that have exhibited (prior to latanoprost therapy) untreated, sitting IOP evaluated with Goldmann tonometry between 25-39 mm Hg at 10:00 (± 1 hour).
* Age between 21-85 years
* Mild to moderate glaucomatous disc damage and visual field loss (less than -12 dB mean deviation visual field loss attributed to glaucoma
* Those with 0.8 or better vertical cup-to-disc ratio and visual acuity greater than 0.1 in the study eye.
* Open anterior chamber angles.
* Those who have to demonstrate a reliable visual field (at least two visual fields with less than 20% fixation losses, false positives, or negatives)
* Patients who understand study instructions, are willing to attend all follow-up appointments and will comply with study medication usage.

Exclusion criteria

* Patients with a history of less than 10% IOP decrease on any IOP-lowering medication.
* Those with evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye.
* Subjects with a history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK)
* Patients with severe ocular surface disease, previous intraocular conventional or laser surgery in the study eye (within 6 months prior to enrolment); previous history of ocular trauma; use of corticosteroids (within 3 months before the enrolment) and use of contact lenses.
* Those that on baseline examination show clinical evidence of inflammation, signs of ocular infection (except blepharitis), signs of any corneal abnormality that will affect subsequent IOP measurements
* Subjects that show unwillingness to participate in the trial.
* Females of childbearing potential or lactating mothers.
Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.

Patients are randomized to one of two arms in a 2:1 ratio (weighted to Arm 1). Arm 1: Replace lamivudine with FTC while continuing on current background regimen. Arm 2: Continue on current lamivudine-containing regimen. Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy. Stratum 1: Less than 50 copies/ml; PI (protease inhibitor) in treatment regimen. Stratum 2: Less than 50 copies/ml; NNRTI (nonnucleoside reverse transcriptase inhibitor) in treatment regimen. Stratum 3: 50-400 copies/ml; PI in treatment regimen. Stratum 4: 50-400 copies/ml; NNRTI in treatment regimen. Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have a viral load below 400 copies/ml.
* Agree to use a barrier method of birth control (such as condoms) during the study.
* Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.)

Exclusion Criteria

You will not be eligible for this study if you:

* Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry.
* Have had a serious medical event within 30 days prior to study entry.
* Are taking hydroxyurea.
* Have Grade 2 or higher peripheral neuropathy.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.
Impact of Fascia Iliaca Block in Hip Fracture Patients

The study is a prospective randomized examining the impact of fascia iliaca block on perioperative pain control and post operative ambulation in patients with hip fractures.

Regional anesthesia is an important element of multimodal pain control regimen for surgical patients. Recently, regional anesthesia using a fascia iliaca block (FIB) to help treat pain in patients who present with hip fractures has been gaining popularity and has been incorporated as part of a multi-modal pain control protocol in many centers. It is commonly offered in addition to oral and intravenous medications to help patients deal with pain in the perioperative period. The block is done by an anesthesiologist under anesthesia using ultrasound guidance. We propose a prospective, randomized study evaluating the efficacy of the FIB as an adjunct in the pre-operative or postoperative period for pain control as measured by visual analog scale (VAS) scores and morphine equivalent dosing (MED), as well as its efficacy in promoting patient participation in physical therapy postoperatively in patients who present with hip fractures. We hypothesize that those patients who receive FIBs will report lower VAS scores as well as decreased narcotic requirement at all time points; and have improved participation in therapy when measured by ambulation distance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with femoral neck and intertrochanteric hip fractures
* At least 18 years of age
* Require operative management

Exclusion Criteria:

* Poly-trauma patients
* Pathologic fractures
* Patient who required revision procedures
* Patients with chronic opioid use
* Patients with a clinical status that precludes verbal pain assessment such as dementia, head injuries, and unwillingness to participate.
Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry.

During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content into the pharynx. This maneuver is called cricoid pressure.

Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid pressure has not been investigated. In this study we have used high-resolution manometry (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the thyroid cartilage and against the trachea) during a rapid sequence induction.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery and Anesthesia with intubation,
* ASA physical status I-II (American Society of Anesthesiologist classification system = system for assessing the fitness of cases before surgery)
* Body Mass Index \> 18,5 and \< 30
* Informed, signed and dated consent

Exclusion Criteria:

* Suspected difficult airway,
* Pharyngoesophageal dysfunction,
* Body Mass Index \< 18,5 or \> 30,
Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder

Temporomandibular joint (TMJ) disorders are health conditions that can occur at any age and are recognized as the most common cause of chronic pain, affecting 5-12% of the population. Pain in the TMJ region can lead to limitations in mouth opening and lateral movements of the mandible.

In cases where conservative treatments are insufficient for TMJ disorders and osteoarthritis, symptoms can be alleviated through arthrocentesis, a minimally invasive procedure with a low risk of complications, or through various intra-articular injection applications following arthrocentesis.

This study aims to compare the clinical efficacy of intra-articular applications of platelet-rich plasma (PRP) and autologous conditioned serum (ACS), both derived from the patient's own blood, in order to evaluate their impact on treatment outcomes and their potential role in enhancing patient care in routine clinical practice."

Temporomandibular joint (TMJ) disorders are health conditions that can occur at any age and negatively impact quality of life. One of the treatment methods for this condition includes arthrocentesis and intra-articular injections.

Among the cytokines identified in orthopedic and trauma-related diseases, interleukin-1 (IL-1) has been shown to have particular significance. Increased local cytokine release triggers the destruction of hyaline cartilage and matrix, leading to osteoarthritis and worsening symptoms. Although the details vary, published studies suggest that when IL-1Ra is present at concentrations 10 to 10,000 times higher than IL-1, all IL-1 receptors and IL-1-triggered reactions can be effectively blocked.

With the Sanakin®-ACRS kit developed by Genesis Biomedical, a patient's blood is drawn, incubated, and then centrifuged, resulting in a serum rich in IL-1Ra and growth factors-known as autologous conditioned serum (ACS). Studies have demonstrated that ACS injections yield highly successful results in treating knee and TMJ osteoarthritis. Additionally, numerous studies have shown that platelet-rich plasma (PRP), which contains a high concentration of growth factors, is also highly effective in wound healing.

This study is designed to compare the effectiveness of PRP and ACS injections-both derived from the patient's own blood but prepared using different methods-in alleviating symptoms associated with temporomandibular joint (TMJ) disorders. The investigation aims to assess their efficacy as accessible, cost-effective, and low-risk treatment alternatives."

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Previously received conservative treatment but no improvement in symptoms
* Patients with TMJ osteoarthritis

Exclusion Criteria:

* Patients who have experienced TMJ trauma or have undergone surgical procedures in this region will be excluded from the study.
* Patients with facial growth disorders, systemic inflammatory joint diseases, condylar pathologies, or signs of myalgia
* Patients who are pregnant or in the lactation period