cyrilzakka/clinical-trials huggingface dataset:
Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.

This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI).

Primary:

-Analog visual eyestrain test score

Secondary:

* Incidence of unexpected adverse events related to the interventions
* Incidence of conjunctival hyperemia
* Incidence of sensation of ocular dryness
* Incidence of ocular irritation
* Incidence of sensation of (sleep-crust)
* Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)

Eligibility Criteria:
Inclusion Criteria:

* Having the ability to voluntarily give their signed informed consent.
* Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
* Age ≥18 years.
* Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \[Tubal Ligation\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
* Present on the analog visual eyestrain test score ≥ 3 on at least 4 of the included questions.

Exclusion Criteria:

* History of hypersensitivity to any of the components of the drugs under investigation.
* Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
* In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
* Having participated in any clinical research study 30 days prior to inclusion in this study.
* Having previously participated in this same study.
* Having a single functional eye.
* Having a history of drug addiction or drug dependence current or within the last two years prior to signing the informed consent.

Elimination Criteria:

* Withdrawal of their consent to participate in the study (informed consent form).
* Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
* Non-tolerability or hypersensitivity to any of the drugs under investigation.
Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial

The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period.

The newborn with metatarsus adducts are included in the study and divide in 2 groups by random.Group A with parents'manipulation of the foot and group B without manipulation of the foot.The parents'foot manipulation is trained by pediatric orthopedic surgeons to correct the deformity.The effectiveness of the manipulation is measured by percentage of no deformity of the foot in newborn after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* newborn with Metatarsus adducts.

Exclusion Criteria:

* 1. criteria were included newborns with associated life threatening conditions. 2. congenital or musculoskeletal problems.(ie;arthrogryposis multiplex congenita,skeletal dysplasia) 3. mental retardation. 4. cognitive impairment. 5. parents incooperative. 6. difficult to follow up patients.
Cerebrotendinous Xanthomatosis (CTX) Prevalence Study

Iiopathic bilateral cataracts occur in many children with Cerebrotendinous Xanthomatosis (CTX) so the opportunity to use contact with health care providers in connection with pediatric cataract evaluation and treatment is a promising avenue for disease detection and prevention.

This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has a diagnosis of idiopathic bilateral cataracts
2. Between the ages of 2 to 21 years at the time of diagnosis

Exclusion Criteria:

1. The patient has a diagnosis of cataracts with known etiology other than CTX
2. The patient has a diagnosis of CTX
3. The patient has cataracts caused by cataractogenic treatments
4. The patient has taken or is currently taking cholic acid or chenodeoxycholic acid
5. The patient has participated in an interventional clinical trial in the past 30 days
6. The patient and/or their parent/legal guardian, in the opinion of the Investigator, is unable to adhere to the requirements of the study
Study Evaluating ERB-041 in Active Crohn's Disease

Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months,
* Eligible subjects must have adequate hematologic, renal, and hepatic function.

Other inclusions apply

Exclusion Criteria:

* Use of the following medications within the specified time period before randomization is prohibited:

Within 48 hours before randomization

* Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization
* Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components).

Other exclusions applies
Predicting Cancer in Pancreatic Cystic Lesions Through Artificial Intelligence

This international, multicenter retrospective study aims to develop a deep learning (DL)-based predictive model to identify malignant transformation in pancreatic cystic lesions, improving upon current clinical guidelines. The model will integrate clinical, biochemical, and multimodal imaging data. Several 3D convolutional neural networks will be trained using advanced preprocessing, data augmentation, and hybrid fusion techniques. Model performance will be compared to that of existing international guidelines. The study involves no additional procedures for patients and adheres to strict data anonymization and privacy regulations.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PCL(s ) who underwent pancreatic surgery in one of the participant centers. Surgical indication must adhere to at least one of current guidelines on PCLs management (6), based on clinical, biochemical, and radiological (MR and/or EUS) features.
* Pancreatic surgery B83performed for supposed increased risk of cyst(s) malignant degeneration following current guidelines on PCLs management (6).
* Absence of clinical, biochemical, radiological, and anatomopathological evidence of pancreatic cancer at pancreatic surgery.
* Non-opposition to the anonymous data processing by the included patients.

Exclusion Criteria:

* Patients presenting with evidence of pancreatic cancer at surgery.
* PCL(s) diagnosis and treatment performed without one between EUS and pancreatic MR. surgery performed in the absence of the criteria proposed by current guidelines.
* Unavailability of both preoperative EUS and pancreatic MR data.
* Unavailability of postoperative PCL(s) anatomopathological analysis results.
* SBO diagnosis performed without CT-scan.
Observational Study for the Evaluation of the Role of HIV-1 Tat Protein and Anti-Tat Immune Response In HIV Reservoir

A longitudinal observational study in HIV-infected subjects receiving cART addressed to explore the effect of the Tat protein and anti-Tat immunity on the formation and maintenance of HIV-1 virus reservoir.

The study is designed as a longitudinal observational study addressed to identify the effects of Tat protein and humoral/cellular anti-Tat immune responses (induced in the natural infection or by Tat vaccination) in HIV-1 reservoir dynamics in blood of HIV infected patients receiving cART. HIV DNA data will be used for analyzing the decay dynamics.

The primary objective of the study is to determine the rate of decay of total HIV DNA in blood of anti-Tat antibody (Ab) positive versus anti-Tat Ab negative HIV patients receiving cART.

The secondary objectives of the study are to relate the HIV DNA decay data to:

1. the persistence of anti-Tat humoral responses;
2. biomarkers of HIV reservoir stability potentially affected by the Tat protein or anti-Tat immune responses, including: i) apoptotic/survival index of CD4+ T cells; ii) reactivation dynamics of latent HIV in resting CD4+ T cells upon exposure to Tat protein and/or activation stimuli; iii) cellular and humoral biomarkers relevant to inflammation and immune dysregulation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Diagnosis of HIV-1 infection
3. To be under cART treatment
4. CD4+ T-cell count ≥250 cells/microliters
5. Testing for anti-Tat Ab performed during pre-screening
6. Signed informed consent

Exclusion Criteria:

1. Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders.
Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

The design of the study includes 3 groups for women with premenstrual syndrome, 1low dose acupuncture in the low-dose group, 2 high dose acupuncture in the high-dose group, and 3 the drug group (contraceptives) . Serum marker change of PGE2, CA125, E2, and progesterone in enrolled patients will be measured before and after treatment, along with VAS and MDQ questionnaires. The treatment efficacy of different groups and the relationship between PMS and patients TCM syndrome pattern will also be recorded and estimated.

Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Women who have such symptoms have been estimated as high as 75%; of which 3% to 8% are severe symptoms, called premenstrual dysphoric disorder (premenstrualdysphoric syndrome, PMDD). The two groups are very similar. PMS is mostly for physical discomfort, while PMDD is for emotional problems, affecting women's sleep seriously.

Regarding the treatment of premenstrual syndrome (PMS), western medicine adopt oral contraceptive pills (OCP) as the first-line medication. However, the common side effects of OCP, such as headache, dizziness, nausea, vomiting, depression, breast pain and so on are also troublesome, In recent years, some women also use acupuncture as an adjunctive replacement therapy because of its safety and fewer side effects. Nevertheless, the factors affecting treatment effect of acupuncture and moxibustion. such as the selection of acupoint s ( of which meridians) or number(dose) of acupuncture ,etc., maight affect the efficacy, yet the relevant research on this issue is not enough. In traditional Chinese medicine theory, acupuncture and moxibustion regulate the energy of the meridians and adjust blood and qi, which in turn help the balance of yin and yang. Female menstrual cycle is a process of conversion between yin and yang in TCM theory. While in western medicine, it is regulated by the endocrine system.

Eligibility Criteria:
Inclusion Criteria:

1.15 to 49 years 2.with a history of regular menstrual cycles (28days±7 days) 3.Symptoms：breast pain、dizziness、bloating、cramps、nausea、vomiting、 diarrhea、headache、 fatigue，etc

Exclusion Criteria:

1. irregular menstrual cycles
2. intrauterine contraceptive device (IUCD/IUD)
3. uncontrolled neurological diseases
4. lactation， pregnant women，or those with plans to get pregnant in the coming half year
Fractionated Stereotactic Radiosurgery for Large Brain Metastases

This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
* The target lesion(s) can be accurately measured in at least one dimension according to RECIST
* No prior radiotherapy to the brain
* Previous or concurrent systemic or targeted chemotherapy is allowed
* Patients must have an extra-cranial primary tumor diagnosis
* Patients will have no more than 3 distinct lesions within the brain. At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
* The additional lesions will each be treated with single fraction stereotactic radiosurgery
* Patient may be on steroids or anti-epileptics
* Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
* Patients do not need a histologically proven diagnosis of brain mets

Exclusion Criteria:

* Symptomatic patients in need of surgery to the "target" lesion
* Four or more newly-diagnosed lesions
* Prior surgical resection of targeted tumor
* Prior WBRT
* Primary brain tumor
* Pregnant or breast-feeding patients
* Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
Advancing Equitable Access to HIV/HCV Testing for People Who Inject Drugs (PWID)

The purpose of this study is to test the effectiveness of the ACCESS strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (SSPs) to implement routine, opt-out HIV and Hepatitis C (HCV) testing and linkage to care for people who inject drugs (PWID).


Eligibility Criteria:
Inclusion Criteria:

* SSPs must:

  1. be operating in an Ending the HIV Epidemic (EHE) or Centers for Disease Control and Prevention (CDC) determined vulnerable jurisdictions;
  2. serve at least 300 unique participants per year;
  3. not currently offer opt-out HIV/HCV testing;
  4. be capable and willing to prospectively collect aggregated, site-level data on the number of participants who are: i) offered HIV/HCV screening, ii) completed these tests, and iii) linked to care, as well as provide participant demographics;
  5. have key staff that consent to participate in study surveys, qualitative interviews and practice facilitation throughout the study.

Exclusion Criteria:

* SSPs must not:

  1. currently receive or have received Frontline Communities in the United States (FOCUS) funding;
  2. have already implemented opt-out HIV/HCV testing.
A Study of IBI362 in Participants With Obesity or Overweight

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

• Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.

Exclusion Criteria:

* HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;
* Weight change \> 5.0% after diet and exercise control for at least 12 weeks before screening;
* Have used or are currently using weight loss drugs within 3 months before screening;
* History of pancreatitis;
* Family or personal history of thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B；
* History of moderate to severe depression or severe mental illness;
* Any lifetime history of a suicide attempt
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )

The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.

This is a Phase 3, single-arm, multicenter open label extension (OLE) study designed to investigate the long-term safety and efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis. Approximately 2200 participants who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies.
* Participants must be candidates for prolonged open label risankizumab treatment according to investigator judgment.
* Females of childbearing potential must have a negative urine pregnancy test result at Baseline.

If female, participant must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocol specified method of birth control, starting at Baseline through at least 20 weeks after the last dose of study drug.

- Participants must have signed and dated a written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission into the study.

Exclusion Criteria:

* Premature discontinuation for any reason in the preceding study.
* Participants who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study.
* Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
* Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the study, compromise the safety of the subject, or compromise the quality of the data.
* Previous enrollment in this study.
* Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or within 20 weeks after the last dose of study drug.
* Time elapsed is \> 8 weeks since the completion visit in the preceding study.
* Participant is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.
Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea

The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 \[fat\]:\[protein+carbohydrate\] ratio, 1600 kcal/day diet (Group A) with weight loss in participants treated with orlistat 120 mg TID and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group C).

The study sample will be randomized into three treatment arms, KD (Group A, n=50), Orlistat 120 mg TID (Group B, n=50) and dietary and lifestyle counseling (Group C, n=50) in a 1:1:1 ratio. Each arm will include 100% participants with obesity and co-morbid type 2 DM and 50% participants with co-morbid OSA. Randomization will be stratified for diabetic status.

Eligibility Criteria:
Inclusion Criteria:

* age 18-70
* ability and willingness to signed informed consent form
* BMI more than 30kg/m2, with type 2 DM and/or OSA
* For diabetic participants, stable hypoglycemic medications for at least 2 months
* For participants with OSA, previously documented polysomnogram with apnea/hypopnea index (AHI)\>15/h.

Exclusion Criteria:

* BMI change of +/- 3.0 kg/m2 of baseline BMI within past 12 months.
* History of bariatric surgery ≤ 3 years prior to enrollment.
* Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer.
* History of uncontrolled hyperlipidemia
* For participants with DM, change in the dose or type of hypoglycemic treatment within 2 months prior to enrollment.
* Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase.
* Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
* History of hyperthyroidism
* History of glaucoma
* History of cerebrovascular disease or unstable heart disease within 6 months of enrollment
* Pregnancy
* Use of any investigational drugs within 3 months of enrollment.
* Inability or unwillingness of subject to give written informed consent.