cyrilzakka/clinical-trials huggingface dataset:
Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting

This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Diagnosis of renal cell carcinoma
* Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
* Patients in whom the oncologist has decide to start therapy with sorafenib.

Exclusion Criteria:

* Synonymous with contraindications to Nexavar.
Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer

This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Researchers will also compare the level and genetic characteristics of circulating tumor elements between individuals with rectal cancer and healthy individuals to understand how they may change over time. Information from this study may help researchers better understand rectal cancer.

PRIMARY OBJECTIVES:

I. To establish the rate of circulating tumor elements (CTE), including but not limited to circulating tumor cells and circulating tumor deoxyribonucleic acid (DNA) detection in patients with locally advanced rectal cancer (LARC), relative to other stages.

II. To assess changes in detected CTEs associated with neoadjuvant therapy in patients with LARC.

III. To correlate CTEs with neoadjuvant treatment response as an indicator of disease risk.

OUTLINE:

Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back.

Eligibility Criteria:
Inclusion Criteria:

* HEALTHY SUBJECT: No known diagnosis of colorectal cancer (CRC) or any other type of cancer for the last 10 years.(basal cell skin cancer is allowed). Subjects will be asked about their cancer history and a verbal confirmation is required
* Any patient with diagnosis of rectal (or rectosigmoid) adenocarcinoma, including:

  * Patients with primary disease with or without neoadjuvant therapy; OR
  * Patients with recurrent disease with or without neoadjuvant therapy; OR
  * Patients with metastatic disease with or without prior treatment
* No known current diagnosis of other invasive cancer; if prior diagnosis of other cancer, he/she has been free from cancer for \>= 3 years and is on no active treatment
* Adequate mental and language capacity to provide consent
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

Approximately 224 adults will be enrolled in an outpatient Phase III study to compare the safety and efficacy of topically applied magainin peptide (MSI-78) to that of ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic, in the treatment of infected diabetic foot ulcers.

This is a randomized, controlled, double-blind trial that will involve twenty or more clinical centers.

Eligibility Criteria:
Inclusion Criteria:

* Non-hospitalized ambulatory patients with diabetes mellitus
* Men or Women greater than 18 years old
* Patients must be considered reliable, willing and able to give consent
* Female patients must be postmenopausal for a least 6 months or surgically sterilized
* Localized infection of the ulcer that would ordinarily be treated on an outpatient basis
* Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected
* Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis
* Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot
* Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry

Exclusion Criteria:

* Patients requiring concurrent local or systemic antimicrobials during the study period for other infections
* Patients who are currently treated or awaiting dialysis
* Patients who are unable to care for their ulcers
* Patients with known alcohol or substance abuse within 6 months or study entry
* Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin
* Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents
* Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.
* Previous enrollment in this study or previous treatment with MSI-78 Topical Cream
* Patients with gangrene or severely impaired arterial supply to any portion of the affected foot
* Other conditions considered by the investigator to be sound reason for disqualification
* Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream
* Women who are breast feeding, pregnant or attempting to become pregnant
Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

* To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.
* To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

1. To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.
2. To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

Eligibility Criteria:
Inclusion Criteria:

In order to be included in the study patient must meet criteria A, C, D, E, F, G plus any 1 of the 3 criteria listed in section B.

A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II

B.

1. Patients meeting DSM-IV diagnostic criteria for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
2. Patients meeting DSM-IV symptomatic criteria for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
3. Patients meeting DSM-IV criteria for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms

C.MADRS of ≥14

D.YMRS of ≥ 14

E. Age 13years to 75 years

F. Male or female

G. Outpatient

Exclusion Criteria:

1. illness precluding the use of LAM
2. Alcohol/drug dependence in the past one month
3. patients with a history of a rash on LAM
4. CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
5. history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
6. patients currently taking LAM
Behavioural Activation-Based Treatment Administered Through Smartphone

The objective is to test the effects of a smartphone-delivered behavioural activation treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be made. We expect the behavioural activation intervention to be superior to the mindfulness intervention for the participants suffering from high severity of depressive symptoms - and the mindfulness intervention to be better or at least as good as the behavioural activation intervention for the participants suffering from low severity of depressive symptoms.

Major depression is expected to be the disorder with the highest disease burden in high-income countries by the year 2030. The efficacy of behavioural activation in the treatment of major depressive disorders has been established in a number of studies over the last four decades. Furthermore, behavioural activation is an intervention that can largely benefit from the use of new mobile technologies (e.g. smartphones). One important feature of mobile technology is the possibility for the therapist to reach the patient between sessions and thus create direct incentives for behavioural activation in everyday life. Therefore, developing smartphone-based behavioural activation interventions might be a way to develop a cost-effective treatment for people suffering from major depressive disorders.

Eligibility Criteria:
Inclusion Criteria:

* depressive symptoms according to DSM-IV
* have access to the Internet and a smartphone
* have good knowledge of the Swedish language

Exclusion Criteria:

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation
A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese female requesting contraceptives

Exclusion Criteria:

* Vascular, metabolic, hepatic, renal, oncologic and other diseases
A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)

To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate asthma patients to permit further clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is judged to be in good health, other than having mild to moderate asthma, based on medical history, physical examination, vital signs, and laboratory safety tests
* Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
* Patient has at least 1 year of mild-to-moderate asthma
* Patient has been a nonsmoker for at least 6 months
* Patients of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
* Patients must be able to swallow tablets

Exclusion Criteria:

* Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, other than asthma, or genitourinary abnormalities or diseases
* Patient has required a visit to a hospital or emergency room due to an asthma exacerbation within 3 months of the prestudy visit
* Patient has unresolved signs and symptoms of an upper respiratory tract infection (URI) or has had had an upper respiratory tract infection within 3 weeks prior to the prestudy visit
* Patient has a history of stroke, chronic seizures, or major neurological disorder
* Patient has a history of neoplastic disease
* Use of theophylline, Singulair (montelukast), Xolair (omalizumab), Zyflo amd Zyflo CR (zileuton), oral corticosteroids and oral beta agonists are excluded approximately 2 weeks prior to administration of study drug and throughout the study
* Patient consumes alcoholic beverages
Treatment After Palbociclib-containing Regimens

To evaluate the prescription patterns and treatment outcomes of subsequent therapies after progression on palbociclib in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. woman, age \> 18 years old
2. Diagnosed with HR+/HER2- Metastatic Breast Cancer
3. Patients received at least one-cycle next-line treatment after progression on combined palbociclib and endocrine therapy
4. Complete medical history was available

Exclusion Criteria:

1. Medical history was incomplete
Study of Adherence to Colonoscopy in Women

The purpose of this study is to determine whether women who are offered screening colonoscopy will be more likely to schedule and complete this procedure if they are given the option of a woman endoscopist.

Colorectal cancer (CRC) is the third leading cause of cancer death in women. Although there are a variety of options for colon cancer screening, colonoscopy is thought to be the best modality for women. Despite recommendations by multiple societies, adherence to CRC screening among women is suboptimal. One possible barrier to adherence may be the gender of the endoscopist. Recent studies have shown that a large proportion of surveyed women would prefer a woman endoscopist. These studies suggest that having the option of a woman endoscopist would increase adherence to colonoscopy; however, there is no published literature that addresses this question.

Hypothesis

Women who are offered screening colonoscopy will be more likely to schedule and complete this procedure if they are given the option of a woman endoscopist.

Specific Aims

Primary

* Determine whether the option of a woman endoscopist is associated with increased woman patient adherence to screening colonoscopy.
* Assess the proportion of women who request a woman endoscopist when this option is made available to them.

Secondary

\* Identify socio-demographic predictors of (a) completing a screening colonoscopy and (b) requesting a woman endoscopist (e.g. race/ethnicity, age, health insurance, marital status).

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age between 50 and 70
* Receiving primary care at a University Medicine clinic

Exclusion Criteria:

* No visit to a University Medicine clinic in 18 months or more
* Deceased
* Pregnant
* Terminal or cancer diagnosis
* No longer receiving primary care at a University Medicine clinic
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair

The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients. The observational trial is a prospective, single arm, open-label, single-center, post market registry.

Significant tricuspid regurgitation is a common finding in elderly patients, with an incidence of 5.6% after the age of 70 years, according to the Framingham Heart Study. TR is an independent predictor for adverse prognosis and has limited treatment options. Tricuspid valve (TV) intervention is indicated when symptomatic TR-related right heart failure (RHF) is present. However, the surgical risk is usually deemed to be too high due to the presence of advanced age, pulmonary hypertension, right ventricular (RV) impairment, major organ failure and other co-morbidities. Moreover, isolated tricuspid valve surgery has an in-hospital mortality of approx. 8,7%, according to recent data.

High TR prevalence, coupled with low incidence of isolated TV surgery, has created a considerable population in need of alternative, percutaneous therapies to improve outcomes. Recently, a variety of interventional procedures and devices have been developed which simulate different surgical approaches like suture or ring annuloplasty, coaptation enhancement, neochordae repair, or even valve replacement. Among them, coaptation devices attempt to correct leaflet malcoaptation by using the edge-to-edge clip technique, similar to treatment of functional mitral regurgitation. To date, most TTVR interventions have been performed off-label with the MitraClip device.

Last year, the first TR dedicated device (TriClipTM, Abbott Medical) has been approved (CE mark), after showing good feasibility, safety and effectiveness, and meanwhile sustained and marked clinical benefit with low mortality after 12 months.

Although most TTVR studies have enrolled high-risk cohorts, criteria for patient selection and timing of intervention have yet to be defined. Based on scientific surgical data, it seems reasonable to expect poorer outcomes in patients with several comorbidities, advanced cardiac remodeling and RHF-related major organ dysfunction e.g., renal and hepatic function impairment. Whether or not this assumption can be extrapolated to TTVR needs to be investigated.

In this registry, the investigators aim to evaluate if percutaneous therapy with the TriClip system is safe and effective in patients at high and prohibitive risk and wether or not procedural success is the main determinant of short-, mid- and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
* Subjects eligible to receive the TriClip™
* Subjects must provide written informed consent prior to study procedure.

Exclusion Criteria:

* Subjects participating in another clinical study that may impact the follow-up or results of this study.
Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* stage III or only pleural stage IV ovarian carcinoma first line treatment

Exclusion Criteria:

* incomplete surgery poor performance status bad general condition
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States

The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.


Eligibility Criteria:
Key Inclusion Criteria:

* Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study.
* A negative pregnancy test is required for female individuals at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than two years post-menopausal).
* All sexually active female individuals who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
* Male individuals who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Oral Manifestation of COVID 19 Patient: A Cross Sectional Study on Egyptian Population

The oral manifestation of COVID 19 that could help in the diagnosis of patient

Oral ulceration,oral lesion,sensitivity that has been reported by patient tested positive for COVID 19

Eligibility Criteria:
Inclusion Criteria:

* Tested COVID positive
* No other chronic disease that has oral manifestation
* Above 18

Exclusion Criteria:

* Children
* Patient with no COVID positive
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)

The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.


Eligibility Criteria:
Inclusion criteria:

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19

Exclusion criteria:

Subjects with allergy
Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating

The purpose of this research study is to pilot test a new intervention that helps young adult women learn adaptive eating and exercise strategies, increase their body acceptance, decrease unhealthy weight control behaviors and prevent future eating and problems. This intervention is experimental, and the study will test its feasibility, acceptability, and effectiveness.

The intervention, Intuitive Eating, is an eating approach that addresses important risk factors and promotes adaptive eating attitudes and behaviors. It has three central tenets: 1) unconditional permission to eat when hungry, 2) eating for physical rather than emotional reasons, and 3) eating according to hunger and satiety cues. Intuitive Eating has ten principles that focus on rejecting the dieting mentality, honoring hunger cues, decreasing restrictive behaviors that lead to deprivation and bingeing, challenging rigid food rules, increasing awareness of satiety, discovering the satisfaction of food, coping with emotions without food, respecting and accepting one's body, using exercise as self-care, and balancing nutrition with satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Not currently pregnant
* Enrolled in postsecondary education at VCU
* Have body image or eating concerns

Exclusion Criteria:

* Eating disorder threshold risk
* Men
* Pregnant women
Study That Will Evaluate the Brazilian Population With COPD.

Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup.

This is a prospective multicentre cohort, non-interventional study. The design is to have multiple medical centres representing the regions of Brazil. Each region has a different exposure to risk factors like tobacco smoke, biomass burning and environmental pollution, has a different population composition and density, degree of urbanization and education level. There are also some inferred genetic differences due to previous colonization and miscegenation. \*CAT (COPD Assessment Test) OU CAAT (Chronic Airway Assesment Test) poderão ser usados intercambiavelmente. The patients will be enrolled in non-random consecutive method and will be followed up for 12 months.

There will be on-site visits at inclusion (V0), 6 and 12 months. There will tele-consults at 3 and 9 months to gather relevant clinical data, with special interest at exacerbation.

There will be 8 participating centres in Brazil, representing all 5 regions (North, Northeast, Midwest, Southeast and South). They will be Teaching Hospitals, Regional Reference Hospitals, Tertiary Hospitals or High Complexity Hospitals. The data will be collected on each site and will be adjudicated by the ARO Team.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged 18 years or older, with confirmed COPD according to GOLD 2024: previous or current exposure and spirometry (FEV1/FVC =2 or CAT \>=10); or
* GOLD E (\>=2 moderate or 1 severe exacerbation - hospitalization); or
* GOLD 3 and 4 (FEV1 \<50%).

Exclusion Criteria:

* Advanced fibrosing interstitial lung disease (extent \>=50%); and/or
* High-risk pulmonary hypertension (on triple therapy); and/or
* Active cancer - on systemic therapy