cyrilzakka/clinical-trials huggingface dataset:
Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.

Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.

This study was draw to treat patients with persistent rhinitis moderate to severe in sites located locally in Brazil.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 12
2. History of allergic persistent rhinitis moderate to severe at least 2 years
3. Proved allergic using PRICK or RAST test
4. Nasal symptoms (NIS) \> 3 and nasal obstruction \>1
5. Indication of nasal corticosteroids use
6. Washout of nasal corticosteroids for 14 days
7. ICF

Exclusion Criteria:

1. Other types of rhinitis
2. Asthma non controlled
3. Use of oral/injectable corticoids 30 days before screening
4. patients not eligible to complete diaries
5. patients with allergy to any substance of medicines
6. non controlled disease
fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma

Rationale: Flap fixation significantly reduces the incidence of seroma formation after mastectomy. Therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle. Previous studies have compared running sutures, interrupted sutures and tissue glue application to conventional wound closure. A recent systematic review with network meta-analysis indicated running sutures as the most optimal technique, however direct comparisons and high quality articles were lacking.

Objective: This prospective trial aims to directly compare running sutures with interrupted sutures in order to prevent complications in patients undergoing a mastectomy.

Study design: This trial will combine a retrospective cohort from the previous SARA-trial in Zuyderland MC with a randomised prospective trial. This study design was chosen to acquire a sample size with sufficient power and the ability to conduct this study in an acceptable time frame.

Study population: A retrospective cohort of patients participating in the SARA trial (RCT) and a prospective cohort of patients undergoing a mastectomy for breast cancer.

Intervention: Group 1: Flap fixation after mastectomy with running sutures. Group 2: Flap fixation after mastectomy with interrupted sutures.

Main study parameters/endpoints: The primary endpoint is the incidence of complications requiring interventions in both groups, including clinically significant seroma, infections and bleeding complications. Secondarily, the length of the procedure and cosmetic results will be compared.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: When participating, patients will undergo 3 additional outpatient clinic visits. Study visits will be combined with regular visits where possible, including the first postoperative visit after 7-10 days and either the 6 week or 3 month visit.


Eligibility Criteria:
Inclusion Criteria:

* Female sex.
* 18 years or older.
* Indication for mastectomy.

Exclusion Criteria:

* Patients undergoing breast conserving therapy
* Patients undergoing direct breast reconstruction
* Patients undergoing modified radical mastectomy
* Unable to comprehend implications and extent of study and sign for informed consent
Implementation of a Collaborative Care Model to Manage Depression Among Adolescents and Young Adults in HIV Services in Thailand

This study aims to investigate the acceptability and feasibility of the implementation of a collaborative care model (CCM) to screen and treat depression. This model will includes cognitive behavioral therapy (CBT) and useof a task-shifting model to address depression among adolescents and young adults (AYA) who are seeking HIV treatment and prevention services at a hospital in Bangkok, Thailand. Analyses will be guided by the consolidated framework for implementation research (CFIR), which will include the identification of facilitators and barriers to implementation of this CCM.

In the last 3 years, 10-20% of AYA patients at King Chulalongkorn Memorial Hospital (KCMH) who seek HIV treatment or prevention services suffer from mental health disorders. As a result, CCM integration for depression screening and treatment was implemented at the 'CU Buddy Clinic' KCMH with the ultimate goal of increasing access to and engagement in mental healthcare with a goal to improve the overall quality of life for Thai AYA. This project will inform a future implementation science study that will focus on how the optimization of integrated mental healthcare into routine AYA HIV treatment and prevention services can impact health outcomes for patients, including ART adherence and long-term viral suppression (AYA living with HIV) and HIV acquisition risk behaviors and PrEP adherence (AYA at risk for HIV).


Eligibility Criteria:
AYA patients at the CU Buddy Clinic (for both quantitative and qualitative study)

Inclusion criteria

* Aged 15-24 years of age
* Starting or currently receiving HIV treatment and prevention services, which includes any individual or combination receipt of the following services: ART, PrEP, HIV testing, receipt of condoms, HIV risk counselling
* Thai Nationality

Exclusion criteria

• Individuals with a history of, or are currently receiving, mental healthcare at the CU psychiatric clinic or elsewhere

Service providers at CU Buddy Clinic

Inclusion criteria

• Current staff providing care at the CU Buddy Clinic with any active patient interface, such as physicians, nurses, peer navigators, psychologists and psychiatrists

Exclusion criteria

* Staff with less than 3 months duration of service at the CU Buddy Clinic
* Staff who are not affiliated with the CU Buddy Clinic
Indication of Ceaseran Section in Primigravida According to Robson's Classification

Rate of caesarean section surgery are rising worldwide,but the determinant of this increase,especially in low-income and middle-income countries, are controversial.In 1985,The world Health organization (WHO) stated;(There is no justification for any region to have a ceasearan section rate higher than 10-15%). Despite the lack of scientific evidence indicating any substantial maternal and perinatal benefits from increasing cs rates,and some studies showing that higher rates could be linked to negative consequences in maternal and child health, CS continue to increase world wide


Eligibility Criteria:
Inclusion Criteria:

* Nullipara
* Single fetus .
* More than 37 weeks .
* Patients who pass into spontaneous
* Patient who induced labour

Exclusion Criteria:

* Non cephalic presentation.
* Abnormal lie
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

Due to halted enrollment, the Phase II part of the study was not conducted. The Sponsor decided to permanently stop recruitment for the study prior to MTD determination.

Remaining patients on treatment with binimetinib and sotrastaurin who were considered by the Investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. No patients were ongoing as of the data cut-off date. After the last patient last visit (LPLV) was declared, the study was terminated.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male and female patients aged 18 years or older
* A history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease
* Consent to providing 3 tumor biopsy samples throughout the course of the study
* Presence of measurable disease
* A WHO performance status of less than or equal to 1

Exclusion Criteria:

* Presence of CNS lesions (stable lesions may be acceptable)
* Previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years
* Adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to CTCAE v4.03 Grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than Grade 2
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
* Impaired cardiac function or clinically significant cardiac disease
* Impaired GI function or disease that could interfere with the absorption of AEB071 and/or MEK162
* Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment
* Females of child-bearing potential who are unwilling or unable to use highly effective means of contraception
* Males who are unwilling or unable to use a condom during sexual intercourse
* Prior exposure to a MEK or PKC inhibitor Other inclusion/exclusion criteria apply
Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome

In this studly, the effects of an 12-week aerobic exercise training in persons with multiple sclerosis with restless legs syndrome will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* A relapsing-remitting or secondary progressive type of multiple sclerosis,
* To be willing to participate in the study.

Exclusion Criteria:

* Another neurological disorder,
* Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
* Diagnosed severe cognitive and/or psychiatric impairment,
* Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
* Having cardiac disease such as hypertension that would be a contraindication to exercise
Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in POI patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels \>25 IU/L recorded on two occasions \>4 weeks apart
* Normal Karyotype: 46, XX
* Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
* Willing to comply with study requirements

Exclusion Criteria:

* Any pathological disorder related to reproductive system anatomy
* AMH \> 8 pmol/L
* Endometriosis
* Adenomyosis
* Fibroids and adhesions
* Infections in reproductive system
* Current or previous diagnosis of cancer in reproductive system
* History of familiar cancer in reproductive system
* Severe male factor infertility
* Prior referral for PGT
* Ovarian inaccessibility
* Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
* BMI\>30 kg/m2 or BMI\<18.5 kg/m2
* Systematic autoimmune disorders
Optimized Treatment of Peginterferon Alfa 2a/2b in Anti-virus Treatment Naive Patients With HBV Related Liver Fibrosis

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment naive patients with HBV related liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 18 to 55 years old;
3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
4. Portal vein diameter ≤ 12 mm from liver ultrasound;
5. Without treatment of anti-virus treatment ever before.

Exclusion Criteria:

1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
2. Pregnancy or lactation;
3. Other active liver diseases；
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Patients can not follow-up.
Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

This study never moved forward due to funding issues.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient with acute alcoholic hepatitis
* Model for End-Stage Liver Disease (MELD) of 15 or greater
* Recent alcohol abuse

Exclusion Criteria:

* Recent infection
* Other life threatening disease
* Severe coagulopathy
* Another non-alcoholic cause of liver disease
Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy

Study of galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.

The doctors are testing galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth. Mesothelioma tumors generally have high levels of WT1.This study was originally designed to have two treatment groups. One group received non-specific immunotherapy with medications called Montanide and Sargramostim (Granulocyte Macrophage Colony Stimulating Factor, GM-CSF). Enrollment to this group has stopped The other group, which continues receives more specific immunotherapy with galinpepimut-S plus Montanide and GM-CSF. Both Montanide and GM-CSF are commonly given along with vaccines because they have a general effect in boosting the immune response. Some researchers believe that this general increase in the immune system may have some effect in treating cancer. Some studies using GM-CSF with melanoma vaccines have suggested that it could lessen the effects of the vaccine. The addition of the WT1 proteins makes this therapy more directed to mesothelioma. The combination of galinpepimut-S with Montanide and GM-CSF has been tested in a prior trial including 9 patients with advanced mesothelioma. In that trial, the vaccine was safe and caused an immune response.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution.
* Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
* Completion of multimodality therapy. This must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy.
* 4-12 weeks since completion of combined modality therapy.
* Age \> or = to 18 years
* Karnofsky performance status \> or = to 70%
* Hematologic parameters: Absolute neutrophil count \> or = to 1000/mcL, Platelets \> or = to 50K/mcL.
* Biochemical parameters: Total bilirubin \< or = to 2.0 mg/dl, AST and ALT \< or = to 2.5 x upper limits of normal, Creatinine \< or = to 2.0 mg/dl.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
* Patients with a serious unstable medical illness or another active cancer.
* Patients taking systemic corticosteroids.
* Patients with an immunodeficiency syndrome.
AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.


Eligibility Criteria:
Inclusion Criteria

Subprotocol A, B, and C

* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
* Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before AMG 193 dosing.
* Homozygous MTAP-deletion
* Able to swallow and retain PO administered study treatment.
* Disease measurable as defined by RECIST v1.1.

Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.

Arm A (AMG 193 + carboplatin + paclitaxel + pembrolizumab):

- Predominantly squamous histology.

Arm B (AMG 193 + carboplatin + pemetrexed + pembrolizumab):

- Predominantly non-squamous histology.

Arm C (AMG 193 + pembrolizumab):

- PD-L1 positive.

Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.

Subprotocol C

* Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
* Brain lesion meeting RANO-BM criteria for measurable disease.

Exclusion Criteria

Subprotocol A, B, and C

* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
* Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
* History of solid organ transplant.
* Major surgery within 28 days of first dose of AMG 193.
* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
* Radiation therapy within 28 days of first dose.

Subprotocol A

- Autoimmune disease or immunodeficiency disease as defined in the protocol'
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project

To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 and older
* Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
* Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
* Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:

  1. Degree of stenosis ≥70% by visual angiographic assessment
  2. Vessel diameter ≥ 4 and ≤ 6mm
  3. Total lesion length (or series of lesions) ≥30 mm and ≤110 mm

     * (Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)
  4. Target lesion located at least three centimeters above the inferior edge of the femur
* Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot