cyrilzakka/clinical-trials huggingface dataset:
Her 2 Testing in Indian Patients With Gastric Cancer

Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. The investigators have very few options for patients with advanced disease.

The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas.

Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients.

1. Study Objective/ Aims Aim: - Rate of Her 2 positivity in 100 consecutive gastric cancer patients Primary Objective

   Test for Her 2 in 100 consecutive gastric cancer patients Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
2. Study Design\& Methodology

   Patients will have the Her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2+ and 3+ result will also have FISH done. This will not affect patient management
3. Overview of Data collection Dr.Bhawna Sirohi the principal investigators will maintain and supervise data collection and maintaining records. The patient will be de-identified.
4. Selection of Study Population

Inclusion Criteria:

100 consecutive patients with gastric cancer who have a pathology specimen at TMH

Exclusion Criteria:

If histopathology blocks were not available

5) Sample size 100 to be enrolled. Patient consent waiver applied for as this does not affect patient care 6) Statistical Analysis It is an Observational study so Results will be given as %age of total population.

Eligibility Criteria:
Inclusion Criteria:

* 100 consecutive patients with gastric cancer who have a pathology specimen at TMH

Exclusion Criteria:

* If histopathology blocks were not available
Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be \>= 18 years of age
* meet Modified NY Criteria definition of ankylosing spondylitis (AS)
* have diagnosis of active AS based on protocol specified criteria
* inadequate response or intolerance to \>= 1 nonsteroidal antiinflammatory drug (NSAID)
* be able and willing to learn to self-administer subcutaneous (SC) injections

Exclusion Criteria:

* Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C
* History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease
* Previous anti-tumor necrosis factor therapy
* Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine)
* Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing
* Biologic or investigational therapy within 6 weeks of study dosing
* Treatment with intravenous (IV) antibiotics within 30 days of study dosing
* Treatment with oral antibiotics within 14 days of study dosing
Efficacy and Safety Study of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers

To verify the role of nab-paclitaxel in second or later-line treatment in advanced biliary tract cancers, the investigators designed a prospective, exploratory, single arm,single center phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as second or later-line treatment in advanced biliary tract cancers.


Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 18 to 75 years
* Radiographically, histologically or/and cytologically diagnosed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer.
* Received at least one first-line systemic treatment for advanced or metastatic diseases and failed, with imaging evidence of disease progression.
* ECOG performance status 0-1
* According to the RECIST1.1 standard, at least one measurable objective lesion should be judged.
* Expected survival more than 12 weeks
* The laboratory test meet the following requirements:

Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5x ULN；AST and ALT) ≤ 2.5x ULN Renal function：Cr ≤ 1.5x ULN，Ccr ≥ 45 ml/min Coagulation function：INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range

* Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver).
* During the non-lactation period, contraceptive measures should be taken in patients of child-bearing age during this trial. The test ofβ- HCG was negative.
* The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form

Exclusion Criteria:

* With Chemotherapy contraindication, known to be allergic, highly sensitive or intolerable to research-related drugs or excipient.
* Pregnant or lactating women.
* Refuse or fail to sign informed consent to participate in the trial
* Grade 2 or above peripheral neuropathy or hemorrhage according to NCI CTCAE 4.03
* Combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(BP≥160/95mmHg), unstable angina, a history of myocardial infarction in the past 6 months,Congestive heart failure\>NYHA grade II, severe arrhythmia, pericardial effusion, etc.
* Patients with severe systemic infections or other serious diseases.
* Combined with other primary tumors
* Patients not suitable for the group according to the judgement of the researcher, with mental disease.
* Patients with symptomatic central nervous system (CNS) metastases who require radiotherapy, surgery or sustained corticosteroid use, and untreated brain metastases that cause any symptoms
* Prior exposure to nab-paclitaxel
* The investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent.
Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia

Primary Objective:

• To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia

Secondary Objective:

• To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years
2. Diagnosed with IBS-D including: a) weekly average of worst abdominal pain in the last 24 hours of ≥3 on a 0-10 scale, and b) weekly average of Bristol Stool form of ≥6 on a 1-7 scale
3. Diagnosed with functional dyspepsia defined as presence of at least one of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning AND no evidence of structural disease that is likely to explain the symptoms
4. History of IBS-D and dyspepsia symptoms for at least 12 weeks
5. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
6. Able to understand the nature and purpose of the study including potential risks and side effects
7. Willing to consent to study participation and to comply with study requirements
8. Successful completion of 2-week placebo-only run-in period, defined as ≥90% product compliance and completion of required questionnaires

Exclusion Criteria:

1. Major gastrointestinal complication, e.g. Crohn's disease or ulcer
2. Prior abdominal surgery with the exception of hernia repair and appendectomy
3. Subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years
4. Clinically significant systemic disease
5. Life expectancy \< 6 months
6. Pregnant female or breastfeeding
7. Lactose intolerance
8. Immunodeficient subjects
9. Anti-psychotic medication within the prior 3 months or major psychiatric disorder within the past 2 years
10. Systemic steroids within the prior month
11. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
12. Use of proton pump inhibitors
13. Eating disorder
14. Recent (\< 2 weeks) antibiotic administration
15. History of alcohol, drug, or medication abuse
16. Daily consumption of probiotics, fermented milk, and/or yogurt
17. Known allergies to any substance in the study product
18. Participation in another study with any investigational product within 3 months of screening
Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial

Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.

Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.

Subjects will be randomized intraoperatively after confirmation of inclusion criteria.

Subjects will be followed-up at 3 weeks, 3 months, 6 months, 12 months and 24 months post-operatively.

Primary outcome is Western Ontario Rotator Cuff Index (WORC) at 12 months. Additional outcomes include American Shoulder and Elbow Surgeons questionnaire (ASES), Single Numeric Evaluation (SANE) score, EuroQoL (5 domains) score (a quality of life score), and Visual Analogue Scale, healing rate as determined by Magnetic Resonance Imaging (MRI) scan at 12 months post surgery. To determine the cost utility, data will be collected on the cumulative cost for the total episode of care up to 12 months post surgery inclusive of surgical costs, implant costs, outpatient costs, and medication costs. Quality-Adjusted Life Years (QALYs) gained will be calculated using the mean total cost and the quality of life score (EQ-5D) improvement from pre-operative to 12 months post surgery.

Eligibility Criteria:
Inclusion Criteria:

\>18 years

- fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing

Exclusion Criteria:

* tears where only a partial repair is achieved
* significant glenohumeral joint arthropathy (Hamada grade 2 and above)
* irreparable rotator cuff tears
* patients unable or unwilling to consent or comply with study questionnaires
* patients with upper limb neurological deficits affecting the ipsilateral limb
* workers compensation cases
* cases involving litigation
Adherence, Improvement Measure (AIM) System

In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18
* Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests
* Detectable Viral Load, based on patient's medical record
* Receiving primary medical care at the AIDS Program at SFGH
* Able and willing to give informed consent to be randomized to study arms
* Willing to use the patient portal
* Has a cell phone with ability to receive and send unlimited SMS texts, Patient of the HIV/AIDS Clinic at ward 86, SFGH

Exclusion Criteria:

Failure to meet inclusion criteria

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A Study of MAX-40279combined With KN046 in Patients With Advanced / Metastatic Solid Tumors

This include two parts, Stage 1 is a dose climbing study and Stage 2 is a dose extending study.

This study is a study of MAX-40279 in patients with advanced / metastatic solid tumors. This study include two Parts, the Part 1 will assess the safety and efficacy of the dose climbing level of MAX-40279, and recommend a dose extending level of MAX-40279 for stage 2.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form.
2. Males and/or females over age 18 and 75.
3. Histologically or cytologically documented local advanced / metastatic solid tumors who have failed standard treatment or cannot obtain standard treatment in the dose escalation stage; dose expansion stage group A: relapsed and refractory advanced gastric cancer; dose expansion stage group B: relapsed and refractory extensive stage small cell lung cancer; dose expansion stage group C: other relapsed and refractory solid tumors except group A
4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Expected survival of more than 3 months.

Exclusion Criteria:

1. The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other adverse reactions without safety risks judged by the investigator)
2. Subject is known to have previous serious allergic reactions to macromolecular protein preparations/monoclonal antibodies, or known to any component of the test drug
3. Active systemic infectious diseases requiring intravenous antibiotic treatment 2 months before the first medication
4. Subject has poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: such as: (1) NYHA class II or higher heart failure or LVEF \< 50%; (2) unstable angina pectoris; (3) myocardial infarction and cerebral infarction within 6 months; (4) clinically significant supraventricular or ventricular arrhythmias are still poorly controlled without clinical intervention or clinical intervention
5. brain metastases, spinal cord compression, carcinomatous meningitis with clinical symptoms, or other evidence of uncontrolled brain and spinal cord metastases, Patients who are not suitable by the investigator's judgment
6. Patients who have experienced ≥ grade 3 immune-related adverse events in immunotherapy (except grade 3 hypothyroidism that can be controlled by drugs)
7. Patients who have other malignant tumors within 5 years before enrollment,Exceptions: a. radical cervical carcinoma in situ or non-melanoma skin cancer; b. radical second primary cancer without recurrence within five years; c. the investigator believes that the double primary cancer can benefit from this study; d. the investigator has clearly excluded which primary tumor source the metastasis
Physiotherapy for Persistent Function by Superficial Neuromodulation

Objectives:

To evaluate pressure pain thresholds, fatigue scales, quality of life and sleep quality, in women with Persistent Covid (PC), pre- and post-treatment using electrotherapy and in a placebo group of PC patients.

Relevance:

This trial can be a tool for patients affected by CP who present pain and fatigue problems, insomnia or signs of imbalance of their Autonomic Nervous System. It aims to improve their rest and recovery for a better quality of life that allows them to recover their Activities of Daily Living.

We have designed the study with a commitment to placebo group treatment after completion, if positive results are obtained.

A 6-month and 1-year follow-up will be scheduled.

Secondary objectives:

To analyze the effects on quality of life, fatigue and sleep. To analyze the presence of cardiac variability and pre- and post-treatment cortisol values.

Patients and Methods:

12 patients with CP will receive 15 sessions of electrotherapy. 12 will receive a placebo.

Mechanical sensitivity pre-post, by means of an algometer, cardiac variability, cortisol levels, and other variables, will be measured by means of questionnaires.

Mechanical sensitivity to pain will be measured using an algometer (Baseline 12-0300 MMT). Patients will be instructed to report when the sensation of pressure changes to pain.

The pre-post electrotherapy treatment described above will be measured, the differences in mechanical sensitivity, pain threshold to pressure, the Pittsburg questionnaires, SF-36, MFIS and EQooL-5.

Follow-up will be done at 6 months and at one year. The study design is a triple-blind randomized controlled clinical trial. Patients who sign the consent form will be evaluated by an internist who will perform a physical examination at the clinic of the Faculty of Nursing and Physiotherapy of the Pontifical University of Salamanca (UPSA).

The sample will be randomized. 12 patients will receive treatment and 12 patients will receive a placebo. With a commitment to treat these patients in the event that positive results are obtained after the end of the study.

A biphasic microcurrent will be applied with a frequency between 1.14 Hertz and 14.29 Hertz and intensities between 0.1 and 0.9 mA.

Frequency: 2 times a week. A total of 15 sessions in 7.5 weeks. The session time with microcurrents will last 60 minutes.

.


Eligibility Criteria:
Inclusion Criteria:

* Women who have had symptoms of PC for more than one year.
* Signs of central sensitization.

Exclusion Criteria:

* Previous treatment with surgery.
* Previous spinal trauma.
* Whiplash.
* Pregnancy situation.
* Previous musculoskeletal disease (rheumatoid arthritis, sympathetic-reflex dystrophy, fibromyalgia).
* Pacemaker.
* Electric drug pump.
* Skin sensitivity alterations.
* Analgesic or anxiolytic drug treatment during the study.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of \<15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-60 years of age;
* chronic hepatitis C;
* chronic renal failure, including patients on hemodialysis therapy;
* detectable HCV RNA levels (\>500IU/mL).

Exclusion Criteria:

* concurrent active hepatitis A or B;
* history or evidence of a medical condition associated with chronic liver disease other than HCV;
* history or other evidence of decompensated liver disease;
* therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \<=6 months prior to study;
* acute renal failure.
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.

PRIMARY OBJECTIVES:

I. To refine the intervention. II. Test the acceptability, feasibility, and clinical appropriateness of the intervention.

III. To provide a preliminary test of its efficacy.

OUTLINE:

Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (MBSR), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.

After completion of study treatment, patients are followed up at 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion
* English speaking
* Able and willing to give informed consent
* To be considered for the blood and saliva collection, women must fulfill the following secondary criteria:

  * Diagnosis of recurrent breast or ovarian cancer with any disease-free interval

Exclusion Criteria:

* Residence \> 70 miles from research site
* Subnormal intellectual potential (diagnosis of mental retardation)
* Progressive neurological or chronic, progressive, debilitating condition (e.g., dementia)
* Non-ambulatory
* Life expectancy less than 160 days, per the treating oncologist
* Current suicide risk sufficient to preclude treatment on an outpatient basis
* Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)