cyrilzakka/clinical-trials huggingface dataset:
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer

The purpose of this study is to evaluate the clinical efficacy and safety of HLX22 in the HER2+ Locally Adanved or Metastatic Gastric Cancer as the first-line therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX22/placebo and SOC(standard of care: Trastuzumab + XELOX) once every 3 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol(whichever occurs earlier).

HLX22(25mg/kg) or HLX22(15mg/kg) or placebo will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy is XELOX (1000 mg/m\^2 capecitabine administered orally twice daily \[BID\] on days 1-14 of each 3-week cycle and 130 mg/m\^2 oxaliplatin administered IV on Day 1 of each 3-week cycle).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric adenocarcinoma.
* HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
* Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Has a life expectancy of greater than 6 months
* Has adequate organ function

Exclusion Criteria:

* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has history of HER2 targeted therapy
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months after the last dose of trial treatment
HIV and Inflammatory or Autoimmune Disease: Rare Patients, Many Questions (MAIVIH)

Follow-up registry of patients living with HIV who also have various inflammatory and autoimmune pathologies that may require immunosuppressive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient living with HIV
* Carrier of one or more of the following diseases:

Sarcoidosis Multiple sclerosis Myasthenia gravis Crohn's disease Hemorrhagic rectocolitis Autoimmune hepatitis Arthropathic psoriasis Still's disease, other rheumatoid arthritides, juvenile polyarthritides, Rheumatoid arthritis Vasculitides: periarteritis nodosa and related conditions, other necrotizing vasculopathies (periarteritis nodosa, juvenile periarteritis, Churg-Strauss disease, polyangiitis, Kawasaki disease, Horton's disease, Wegener's disease, thrombotic microangiopathy, Takayashu syndrome, Good-Pasture's syndrome, thrombocytopenic purpura) Lupus Polymyositis or dermatopolymyositis Connectivitis (Behcet's disease, Gougerot-Sjöogren syndrome) Inflammatory spondyloarthropathies (APS, spondyloarthritis, other spondyloarthropathies)

Exclusion Criteria:

* Opposition of the person
* Minor patients
* Patients under judicial protection
Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura

OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura.

II. Evaluate the toxicity associated with this treatment regimen in these patients.

III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients.

PROTOCOL OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients who achieve a clinical response lasting over 4 months may receive a second course of rituximab.

Patients are followed at 5, 6, 8, and 12 weeks, and then at 6 and 9 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 75,000/mm3 on two occasions at least 1 week apart within past month

Normal to increased numbers of megakaryocytes on bone marrow examination within past 6 months

Failed prior steroid therapy (i.e., unable to achieve sustained platelet count greater than 75,000/mm3)

No drug associated ITP

No B cell malignancies

No evidence of disseminated intravascular coagulation (DIC)

--Prior/Concurrent Therapy--

Endocrine therapy: Concurrent steroids allowed as long as platelet count is less than 75,000/mm3 and dose is not changed within past 2 weeks or during study

Other:

* No other concurrent medical therapy for immune thrombocytopenia purpura (ITP)
* At least 2 weeks since prior therapy for ITP (except steroids)
* At least 4 weeks since prior cyclosporine

--Patient Characteristics--

Performance status: ECOG 0-2

Life expectancy: At least 6 months

Renal: Creatinine no greater than 2.0 mg/dL

Cardiovascular: No congestive heart failure or symptomatic coronary insufficiency

Other:

* No clinically significant bleeding (i.e., other than mild mucosal bleeding or petechiae)
* No sepsis or fever
* No active infection requiring therapy
* No active chronic viral infection
* HIV negative
* No other concurrent or prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients

Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of correspondent analogues. The main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients HIV positive \> 18 years.
* Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
* HIV-ARN \< 50 copies/mL in the las six months.
* Clinically evident lipoatrophy (moderate or severe).
* Negative pregnancy test.
* Signed informed consent.

Exclusion Criteria:

* Evidence of failure or mutation to therapy with protease inhibitors.
* Patients that can not be treated with LPV/r.
* Mild lipoatrophy.
* History of alcoholism or drug addiction that discourages participation in the study.
* Pregnancy or breastfeeding.
* Documented current or 4 weeks prior opportunistic infection.
* Creatinin clearance \< 60mL/min.
* Concomitant use of nephrotoxic drugs or immunosuppressants.
* Actual treatment with systemic corticosteroids, IL-2 or chemotherapy.
* Patients under treatment with other drugs in investigation.
* Acute hepatitis.
* Any other disease that discourages participation.
Improving Medication Reviews to Polypharmacy Patients

Brief summary: The randomised controlled trial investigates the effect of a pharmacist intervention targeting polypharmacy patient at two levels medical clinics and patient level. The purpose is to gain more knowledge to patients and physicians about their medication and to see changes in the patient's medication and health-related quality of life.

The main objective of the randomised controlled trial is to investigate the clinical effects of the roll-out of the systematic offer from Nord-KAP in the North Denmark Region at two different levels (medical clinic and patient-level). The primary outcome is changes in the participant's medicine from baseline to follow up and changes in healthcare usage Secondary outcomes include investigation of cost-effectiveness and changes in patients health-related quality of life.

The hypothesis is that the regional intervention delivered by the pharmacists, from Nord-KAP, can lead to a decrease in medical products compared with a control group between baseline and at 6-month follow-up.

* Will the use of a pharmacists intervention lead to a decrease in the number of polypharmacy patients in medical clinics compared to a control group of medical clinics?
* Will the use of a pharmacist intervention lead to an increase in the polypharmacy patients health-related quality of life compared to a control group?

Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 5 medicinal products prescribed besides skin remedies and antibiotic
* Above 18 years
* Patients in continuous medication treatment

Exclusion Criteria:

* Terminal patients
* Patients who are not motivated to comply with the instruction of the trial
* Do not speak/or understand written Danish
* Patients lacking legal capacity
* Patients living at nursing homes
Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men

This study aimed to assess the effect of IDEP on ED and its associated psychological burden in HD men. Forty HD men with ED were randomly assigned into the IDEP group (this group contained 20 HD men with ED who received intradialytic cycling three times per week) and the control group (this group served as waitlist men). outcomes : Five-Item International Index of Erectile Function (FI-IIEF), ten-question Rosenberg self-esteem scale (TQ-RSES), version three of the Revised UCLA Loneliness Scale (LS), the revised version of Impact of Event Scale (RV-IES), Beck's Depression Inventory (BDI), and State-Trait Anxiety Inventory (S-TAI) were assessed before and after 12 weeks.

This study aimed to assess the effect of IDEP on ED and its associated psychological burden in HD men. Forty HD men with ED were randomly assigned into the IDEP group (this group contained 20 HD men with ED who received intradialytic cycling three times per week) and the control group (this group served as waitlist men). outcomes :Five-Item International Index of Erectile Function (FI-IIEF), ten-question Rosenberg self-esteem scale (TQ-RSES), version three of the Revised UCLA Loneliness Scale (LS), the revised version of Impact of Event Scale (RV-IES), Beck's Depression Inventory (BDI), and State-Trait Anxiety Inventory (S-TAI) were assessed before and after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men gender
* Hemodialysis for at least 6 months their
* Age between 35 to 48 years old.
* Married patient
* Education level.
* The problem of ED was diagnosed by a physician at least 6 months before enrollment in this study.

Exclusion Criteria:

* prostatic disorders
* systemic diseases (diabetes mellitus or hypertension)
* cardiac diseases
* musculoskeletal issues (e.g. muscle contusion, osteoarthritis, osteoporosis, osteopenia, etc.),
* persistent hyperkalemia
* penile shaft problems/implants
* malignancies, acute/chronic infection or inflammation
* autoimmune disease
* cerebrovascular accidents/insults
* a history of frequent hypoglycaemic episodes,
* absolute contraindications to cardiopulmonary training/exertion
* respiratory or liver diseases
* participation in another structured interdialytic or intradialytic exercise programs
* neurological diseases
* consumptions of ED pharmacotherapies
* previous pelvic surgeries
* radiotherapy
* low levels of testosterone or sex hormones,
* psychological diseases
* Present history of smoking or alcohol consumption.
A Trial for Patients With Advanced/Recurrent Endometrial Cancer

The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have recurrent or persistent endometrial adenocarcinoma, which is refractory to curative therapy or established treatments.
* Patients must have measurable disease.
* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma.
* Patients must have signed an approved informed consent.
* Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study and for at least 3 months following the last dose of Pemetrexed.
* Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5 days prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life of the NSAIDs treatment.
* Patients must agree to this schedule in conjunction with every dose of Pemetrexed.
* Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting 7 days prior to the first treatment with Pemetrexed.
* Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after the last dose of Pemetrexed.
* Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the dose, the day of and the day after every dose of Pemetrexed.
* Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the first treatment with Pemetrexed.
* Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3 weeks after the last dose of Pemetrexed.

Exclusion Criteria:

* Patients who have had prior therapy with Pemetrexed
* Patients who have received radiation to more than 25% of marrow bearing areas
mCBCT in Combination With ENB for the Diagnosis of PPNs

This study aims to evaluate the clinical value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mCBCT in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mCBCT adjustments.

This study is a prospective, single-arm, single-center observational clinical trial to evaluate the diagnostic value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules. The investigators will adjust the position of electromagnetic navigation bronchoscopy base on the intraoperative 3D imaging findings of mCBCT. The value of mCBCT in improving diagnostic yield is explored by comparing the diagnostic yield Post-mCBCT with that of Pre-mCBCT. The Pre-mCBCT diagnostic yield is the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and with no need for adjustment after mCBCT spin confirmed "tool-in-lesion" during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield is the proportion of diagnosed patients with and without adjustment after mCBCT spin during the procedure in all enrolled subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject with age of 18 years and older
* Chest CT imaging shows the presence of peripheral pulmonary nodules (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) suspicion of malignancy that need to be confirmed by pathology
* Pulmonary nodules of \> 8mm and ≤30 mm in largest dimension
* Patients without contraindications of bronchoscopy
* Patients have good medical adherence and signed informed consent

Exclusion Criteria:

* Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
* Presence of concomitant endobronchial lesion during the bronchoscopy procedure
* Pre-operative mCBCT spin scan showed no visible lesions
Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.

The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).

Eligibility Criteria:
Inclusion Criteria:

* Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment.
* No current chemotherapy.
* Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone).
* Ability to engage safely in moderate exercise as determined by their treating physician.
* Not previously engaged in regular exercise training (\<3 or more d/wk for \> 30 min/d or \<90 mins per week total including strength training, aerobic training, or walking) in the past 6 months.
* Access to a computer or a smart phone for syncing and uploading wearable activity data.
* Be able to speak and read English.

Exclusion Criteria:

* Any condition that causes severe pain with exertion.
* History of bone fractures.
* Active cardiovascular disease including any of the following:

  * New York Heart Association (NYHA) Grade II or greater congestive heart failure .
  * History of myocardial infarction or unstable angina within 6 months prior to Day 1.
  * History of stroke or transient ischemic attack within 6 months prior to Day 1.
* Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol.
* Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise.
* Neurological conditions that affect balance and, or muscle strength.
* Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent.
Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients

Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20 mg as appropriate. However, probably because of the dramatic response of PMR to GC, randomized controlled trials of treatment are lacking. As a result, there is no evidence from controlled studies on the efficacy of different initial doses or drug tapering. Objective of the study: to test if 12.5 mg prednisone/day is an adequate starting dose in polymyalgia rheumatica (PMR) and to evaluate clinical predictors of drug response.

Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible predictors of response to prednisone. Remission is defined as disappearance of at least 75% of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a scenario allowing steroid tapering.


Eligibility Criteria:
Inclusion Criteria:

* patients with PMR, diagnosed according to the criteria of Bird et al

Exclusion Criteria:

* patients with arthritis
* patients with giant cell arteritis
* patients with Parkinson's disease
* patients with hypothyroidism
* patients with scapulohumeral periarthritis
* patients with fibromyalgia
* patients unable to cooperate
¡Salud! Por la Vida (SPLV) A Colorectal Screening Promotion Program

The overall goal of this educational program was to increase colorectal cancer screening (CRCS) in men and women who attend Federally Qualified Health Centers (FQHC) in Puerto Rico. FQHCs, referred to in Puerto Rico as "Clínicas 330", are ideal settings to implement innovative approaches to increase CRCS because they serve primarily low-income patients who typically have lower rates of screening. The goal of this study, is to develop and evaluate the impact of a clinic level intervention on increasing CRCS among low-income Puerto Rican men and women aged 50-75, who have either never been screened for colorectal cancer, or are under-screened according recommended guidelines. To evaluate the delivery of the CRCS education program we used a group randomized controlled trial that provided data to determine the effectiveness of the CRC intervention program compared with usual practice (no intervention).


Eligibility Criteria:
Inclusion Criteria:

* Female aged 50-75, patient at a participating FQHC.
* Male aged 50-75, patient at a participating FQHC.

Exclusion Criteria:

* Having completed a fecal occult blood test (FOBT) or a fecal immunochemical test (FIT) in the past year.
* Having completed a sigmoidoscopy in the last 5 years.
* Having completed a colonoscopy in the last 10 years.
* Prior history of colorectal cancer.