cyrilzakka/clinical-trials huggingface dataset:
BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole


Eligibility Criteria:
Inclusion criteria:

* Female patients with histologically proven breast adenocarcinoma
* Presence of metastatic disease No more than 2 prior chemotherapy regimens for metastatic disease, which could include trastuzumab Patients must currently be on letrozole and developed acquired resistance as defined by disease progression on letrozole following previous response (partial response or better, stable disease superior or equal to 24 weeks)

Diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined as:

1. Increase in the number of bone lesions on bone scan or on MRI AND/OR
2. Increased pain in an area of known bony metastasis AND superior or equal to 2 serial elevations in CA 15.3 AND/OR
3. Progression according to RECIST criteria on CT scan, MRI, or x-ray Patients must have documented menopause confirmed by estradiol level inferior to 11 pg/ml

Exclusion criteria:

* Premenopausal patients
* Rapidly progressive disease in major organs (i.e. lymphangitic spread in the lung and/or bulky liver metastasis) Patient with brain metastasis Significant cardiovascular diseases Previous treatment with an EGFR and/or HER-2 inhibiting drug(patients who received trastuzumab with chemotherapy but not with letrozole can be enrolled)
Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.

The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD patients without conventional for LTOT but with exercise desaturation.

Oxygen will be administered through nasal cannulae. Patients will be provided with a tank of liquid oxygen and a rechargeable portable device. The 6 minuts walking test will be used to adjusted oxygen flow in the GFA group (to achieve a mean SpO2 ≥ 90%). In the control group (GC), a 3L/min oxygen flow will be administer. Oxygen is used when the patient perform physical activity. The treatment period for each patient is 6 months (3 months in the GC grup, 3 months in the GFA one).

Eligibility Criteria:
Inclusion Criteria:

* Clinical stable moderate to severe COPD (FEV1 \<70%, FEV 1 / FVC \<70%) total lung capacity (TLC\> 80%) without conventional criteria for LTOT, optimal medical therapy, mean SpO2 ≤ 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation.

Exclusion Criteria:

* Current smokers - Presence of respiratory failure and criteria for LTOT (PO2 \<55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Presence of impaired mobility - Cognitive impairment or intellectual disability to fill in questionnaires - No acceptance of liquid oxygen - Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) - Participation in pulmonary rehabilitation programs
Treating Pain to Reduce Disability Among Older Home Health Patients

The overall goal of this real-world comparative effectiveness research (CER) study is to reduce disability among older home health patients by treating their pain more effectively. To achieve this goal the investigators will conduct a cluster randomized controlled trial of a physical therapist (PT) delivered intervention provided to VNSNY home health care patients with activity-limiting pain. The intervention is an evidence-based non-pharmacological program to reduce pain and pain-related disability that utilizes cognitive-behavioral pain self-management (CBPSM) techniques.

This project will compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques. The project also will examine differences in the effectiveness of the intervention among different race/ethnicity groups and individuals with different pain types, as well as the fidelity of intervention-group PTs to the CBPSM program.

The specific aims of this CER study that will include sizeable numbers of Hispanics, non-Hispanic African Americans and non-Hispanic white patients ages 55 and older are: (1) to compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques; and (2) to examine the heterogeneity of CBPSM treatment effects among patients with different pain conditions and minority group status.

Eligibility Criteria:
Inclusion Criteria:

* VNSNY patient in the adult home healthcare program
* Services are being provided in the Bronx, Brooklyn, Manhattan, Queens, Staten Island, Nassau or Westchester
* VNSNY Plan of Care includes physical therapy
* Age 55 or older
* Speaks English
* Has a telephone
* Activity-limiting pain

Exclusion Criteria:

* Significant cognitive impairment
Study to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 Pneumonia

To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the severity and progression of pulmonary and renal dysfunction and mortality in adult patients hospitalized with COVID-19 pneumonia


Eligibility Criteria:
Inclusion Criteria:

1. Patient is a male or nonpregnant female 18 years of age or older.
2. Patient has a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample during the current hospital admission.
3. Patient has pneumonia confirmed by chest imaging.
4. Patient has moderate to severe disease based on the WHO disease severity scale assessment at the time of randomization defined as:

   * Score 4, only those with FiO2 \> 40%
   * Score 5 (Non-invasive ventilation or high-flow oxygen)
5. Patient has ability to provide informed consent signed by study patient or legally acceptable representative.
6. Patient has willingness and ability to comply with study-related procedures/assessments

Exclusion Criteria:

1. Has an active malignancy or history of solid or hematological malignancies within 5 years prior to enrollment in the study. Patients who had basal or squamous cell carcinoma-in-situ of the skin that was diagnosed \> 2 years prior to the study enrollment and not currently being treated are eligible for study enrollment.
2. Patient is pregnant or breast-feeding.
3. Patient, in the opinion of the investigator, is unlikely to survive for ≥48 hours from the time of screening.
4. Patient has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
5. Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) \> 3x upper limit of normal (ULN) and/or total bilirubin \> 2xULN at baseline
6. Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®)
7. Patients participating in any other clinical trial with an investigational drug product or procedure
8. Recipients of solid organ and/or hematopoietic cell transplantation
9. Patient is known to have End Stage Renal Disease (ESRD) and was being treated with maintenance hemodialysis or peritoneal dialysis prior to the current hospitalization.

Note: Patients who initiated RRT due to Acute Kidney Injury during their current hospitalization will be eligible for the study
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients

The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 2 to \<18 years of age; Subjects 2 to \<12 years of age will be permitted to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms the proposed dosage corresponding to this age group is appropriate.
* Patients with confirmed Candida infection of the blood, body tissues, or the esophagus.
* Patient's doctor feels voriconazole is an appropriate choice of therapy.

Exclusion Criteria:

* A known allergy to voriconazole or to azole to antifungal drugs.
* Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control.
* A patient who is receiving treatment with a drug know to interfere with the heart's electrical system (QTc prolongation).
* A patient who is receiving treatment with a drug that is not permitted to be used with voriconazole.
* For primary therapy: a patient who has received more than 48 hours of antifungal therapy for the current episode of Candida infection.
* A patient with significant underlying liver disease at the time of enrollment in the study.
* A patient with significant renal disease (CrCl \< 50 ml/min) at the time of enrollment in the study.
* A patient with a high likelihood of death within 72 hours of study enrollment due to factors unrelated to Candida infection.
Management of Vaginal Fistula by Kshar Sutra, a Minimally Invasive Treatment

Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an ancient surgical problem. It was commonly described even in the Vedic period. The description of Bhagandara, with the full text of its managements, can be gathered from the Sushruta Samhita, which is supposed to have been written in the second century B.C. Fistula-in-ano is a tubular ulcer formed around the peri-anal region. It may also be found anywhere in the perineal region. Its ramifications can extend to the lower back, subscrotal region, vagina etc.

Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment due to probability of recurrence after surgery. The present treatment modality Kshar Sutra has been found effective and as adjuvant therapy by avoiding recurrence.

A 42 years old female patient , come to the Shalyatantra O.P.D. of Government Ayurved Hospital,Nagpur with complaints of recurrent discharging boil at right side of Perianal region along with pain and discomfort in October 2010.

She gave a surgical history of incision and drainage for gluteal abscess done in year 2008 and after six month. The same complaint recurred after next six month .On local examination Patient had discharging sinus at 9 o clock position on right side of Perianal region. Before planning the treatment other etiologies like tuberculosis, diabetes mellitus , HIV or trauma were ruled out.

For the conformation of diagnosis Fistulogram was performed suggestive of low anal fistula with posterior internal opening. So under spinal anaesthesia probing was done. But it came to know that the track was directed upward in vagina and it had not any other opening in anal canal. Length of the tract was 7cm.

After conformation of vaginal fistula the track was cleaned with betadine and Hydrogen peroxide. The Kshar Sutra was tied covering the entire underlying track for simultaneous cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. Patient was advice for Seitz bath with lukewarm water. The Kshar Sutra was changed weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed.

The total period of Kshar Sutra treatment was two month. The track cut trough and simultaneously healed. It was observed that healing rate was slow as compare to cutting rate. In this patient. The patient was observed for a period of two year to check for recurrence.

The Kshar Sutra is a standard medicated thread smeared with Kshar of Apamarga (Achyranthus Aspera), Shnuhi (Euphorbia Nerrifolia)latex which has quality of cutting and Haridra (Curcuma Longa) which is used as a antiseptic. This combination of drugs on the thread helps in debridement and simultaneously healing.

Eligibility Criteria:
Inclusion Criteria:

* without any major illness like Diabetes, Hypertension, Asthma, Tuberculosis, and without multiple track.

Exclusion Criteria:

* with Major illness, multiple Fistulas, associated anorectal conditions
Genomewide Search for Loci Underlying Metabolic Syndrome

To identify the genes involved in the metabolic syndrome.

BACKGROUND:

Metabolic syndrome, characterized by clustering of multiple metabolic abnormalities including abdominal obesity, dyslipidemia, hyperinsulinemia, hyperglycemia, and hypertension, is one of the most important risk factors for cardiovascular disease and stroke. Genetics play a significant role in determining the individual susceptibility to metabolic syndrome and the inter-individual variation in its associated phenotypes, though these genetic factors remain largely unknown. The long-term goal is to identify the metabolic syndrome susceptibility genes and their functional variants.

DESIGN NARRATIVE:

The goal of the research is to study the underlying phenotypic structure of the metabolic syndrome and to systematically search for genetic loci predisposing to the metabolic syndrome using the genome scan approach. The specific aims are: (1) to screen about 10,000 sibling pairs aged 40 to 64 years in Anqing, Anhui China, on intermediate phenotypes of the metabolic syndrome including body mass index, waist and hip circumference, serum lipid profiles (triglyceride, HDL-, LDL-, and total cholesterol), fasting serum glucose and insulin level, and blood pressure; (2) to study the underlying phenotypic structure of the metabolic syndrome in the about 10,000 ascertained sibling pairs using factor analysis; (3) to select and genome scan 800 nuclear families from the pool of the ascertained sibling pairs using Weber screening set 10 markers. Each selected nuclear family contains a "proband" and \>=3 other family members. The values of the three most significant factors for metabolic syndrome in the factor analysis (see specific aim 2) will be used to classify "proband" status for each subject. A "proband" is defined as having \>=2 out of 3 factor values falling into the same side of the 10/90 percentile tails of the corresponding age- and sex-adjusted population distributions; (4) to test for linkage in the genome-scanned families on intermediate phenotypes and factors of metabolic syndrome using the Unified Haseman-Elston method. In addition to the univariate test, linkage analysis will be performed using a novel multivariate version of the Unified H-E method, which has recently been proposed and shown to be significantly more powerful than the univariate test for traits with common genetic determinants; (5) to perform expansion or replication linkage studies on loci identified in the genome scan in 300-400 additional families with \>=1 proband with a denser set of markers.

Eligibility Criteria:
No eligibility criteria
Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate

Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.

During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors).

In addition, closure of peritoneum should be accomplished using this device.

Eligibility Criteria:
Inclusion Criteria:

* Inguinal hernia,
* femoral hernia

Exclusion Criteria:

* pregnancy,
* not able to understand patient information
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 30 to 65 years
* Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion Criteria:

* A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
* Any systemic skin diseases or local skin abnormalities in the area of application
* Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
* A medical condition that could affect or interfere with sexual function
* Using a systemic transdermal gel or cream estrogen therapy.
Body Fat Percentage Prediction Model After Basic Combat Training on Army Candidate in Indonesia

This research is a quantitative study using the Pre-Experimental Model One-Group Pretest-Posttest Design with total sampling from the Republic of Indonesia Defense University batch 4 cadets that fullfiled criteria. The intervention is 12 weeks basic combat training (only one group), a compulsory program for cadets.

the purpose of this study is know the effect of basic combat training on the anthropometry and body fat percentage prediction model of army cadets after basic combat training in Indonesia

Eligibility Criteria:
Inclusion Criteria:

* Students as fourth batch in bachelor program in Indonesia Defense University
* Aged 16-18 years

Exclusion Criteria:

* Drop out or resign from Indonesia Defense University during research
* Having emergency condition during examination
Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL

Multi-center retrospective analysis of patients with DLBCL aged ≥80 years old treated with R-CHOP-14 compared to other regimens. Patient data including baseline characteristics, histology, dose intensity and treatment outcomes will be extracted from hospital medical electronic records. Relative dose intensity (RDI) will be calculated as the percentage of the dose intensity achieved divided by the intended dose intensity. Primary endpoints are overall (OS), progression-free (PFS) and event-free survival (EFS), defined as time from diagnosis to death, death or progression/relapse, progression/relapse or treatment discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven, untreated diffus large B-cell lymphoma (DLBCL)
* diagnosis between 2005 - 2019
* age ≥80 at diagnosis

Exclusion Criteria:

- diagnosis revision at a later timepoint
Breath Test for Early Detection of Lung Cancer

To demonstrate and validate a breath test for detection of early stage lung cancer that could potentially reduce number of deaths.

This is a multicenter study comparing several groups of subjects with and without lung cancer by CT scan, biopsy and the breath test. The breath test will be performed to validate the methodology and the predictive algorithm that were previously developed.

Eligibility Criteria:
Group 1 - Asymptomatic High Risk Subjects

Inclusion criteria

1. Patient is willing and able to cooperate with study and give signed informed consent to participate.
2. Patient has had (or will have) chest imaging with spiral CT within 7 days of breath test.
3. Age at least 18 years.
4. History of at least 10 pack-years of cigarette smoking.
5. Provide written informed consent prior to admission into the study.

Exclusion criteria

1. Previously documented history of cancer of any site.

Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis

Inclusion criteria

1. Patient is willing and able to cooperate with study and give signed informed consent to participate.
2. Patient does not have a tissue diagnosis of pulmonary disease.
3. Patient is undergoing evaluation for an unexplained pulmonary illness which is clinically consistent with lung cancer. This includes patients with unexplained symptoms (e.g. chronic unexplained cough or hemoptysis), unexplained signs (e.g. weight loss, lymphadenopathy) or unexplained investigations (e.g. an abnormal chest x-ray).
4. Actively smoking patients, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded.

Exclusion criteria

1. Previously documented history of cancer of any other site.

Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis

Inclusion criteria

1. Patient is willing and able to cooperate with study and give signed informed consent to participate.
2. Patient has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than lung cancer e.g. sarcoidosis, COPD, or pulmonary infection.
3. A diagnosis of lung cancer is defined as cytologic or histologic confirmation of lung cancer by bronchoscopic/thoracoscopic means, sputum cytology, percutaneous fine needle aspiration biopsy. Patients may have either non-small cell lung cancer or small cell lung cancer.
4. Breath VOC collection will be obtained prior to any invasive procedure e.g. thoracotomy, mediastinoscopy or mediastinotomy.
5. Actively smoking patients, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded.

Exclusion criteria

1. Previously documented history of cancer of any other site.

Group 4 - Apparently healthy subjects

Inclusion criteria

1. Willingness to follow protocol requirements as evidenced by written, informed consent.
2. Healthy, male or female subjects, ages 18 and older.
3. Subjects who are non smokers having no signs or symptoms of lung carcinoma

Exclusion Criteria

1. Any active ongoing medical problems.
Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes

The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief.

The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.


Eligibility Criteria:
Inclusion Criteria:

* 1. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia

Exclusion Criteria:

- 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery.

5. Evidence of anticipated fetal anomalies