cyrilzakka/clinical-trials huggingface dataset:
Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients

This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer

There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity.

Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic gastric cancer.
* Measurable or evaluable disease.
* Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
* Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
* Karnofsky performance status \> 70%.
* Age ≥18 years.
* Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function.
* Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

* Active infection
* History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow.
* Patients with CNS metastases
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction.
* Malnutrition or loss of \> 10% of body weight during the last month.
* Peripheral neuropathy ≥ grade 2
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
* Psychiatric illness or social situation that would preclude study compliance.
* Pregnant or lactating women.
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.


Eligibility Criteria:
KEY Inclusion Criteria:

1. Male and female patients ≥ 18 years with a body weight ≥ 45 kg.
2. Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.
3. P. falciparum parasitaemia of 500 to 50 000 parasites/µL.
4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
5. Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.

KEY Exclusion Criteria:

1. Mixed Plasmodium infections.
2. Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).
3. Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.
4. Clinical or laboratory evidence of any of the following:
5. AST/ALT \> 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
6. AST/ALT \> 1.0 and ≤ 1.5 x ULN and total bilirubin is \> ULN
7. Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT
8. History of photodermatitis/increased sensitivity to sun.
9. Pregnant or nursing (lactating) women.
10. Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.
11. Moderate to severe anemia (Hemoglobin level \<8 g/dL).

Other protocol-defined inclusion/exclusion criteria may apply
Immediate Implant Placement in Aggressive Periodontitis

The aim of the present study is to evaluate the health of immediately placed dental implants in aggressive periodontitis patients versus those placed in periodontally healthy individuals in the maxillary esthetic zone.

Aggressive periodontitis is an enigmatic periodontal disease that characterized by massive and undeterminable periods of tissue destruction. It gets along well to young individuals with successive periods of disease activity. Aggressive bone destruction with limited plaque and calculus deposits usually detected. According to microbial theory, Aggregatibacter actinomycetemcomitans (A.a) and P. gingivalis (P. G) were claimed for such a disease. Patients of aggressive periodontitis have disturbed esthetic and masticatory function problems.

After wards, microbial theory was modified to enroll the genetic background that can be the cause behind the developed body resistance. Although the importance of the genetic treatment to improve the body response, it was totally dismissed during the routine periodontal work attributable to high cost effectiveness of the needed genetic analysis especially in developing countries.

Further researches tried to explain the cause behind the impaired body response. Impaired functions of the immune cells and the massive amounts of catabolic cytokines such as IL-1, IL-6, Il-17, TNF- α and prostaglan¬din E2 (PGE2) are usually released during the active periods of the disease. On the other hand, matrix-metalloproteinases are destructive enzymes that released in an uncontrollable manner. Host modulators were suggested to control the released of the destructive agents.

Immediate implant placement provides an efficient modality that shortens the dental management period. The aim behind immediate implant placement is the proper implant positioning to counteract the advanced bone resorption following extraction.

Periodontitis is considered an important risk factor for peri-implantitis. The pre-existing periodontitis must be treated prior to implant placement in order to avoid the bacterial accumulation in the periodontal lesions regardless the type of periodontitis. Local and systemic supportive therapy is strongly recommended in order to reduce the microbial colonies and post-operative bone loss.

Higher rate of implant failure (peri-implantitis) has been reported in immediately placed implants when compared with the delayed conventional technique. The failure rate markedly increased with the immediate placement of implants in patients with history of periodontitis especially the aggressive form.

Eligibility Criteria:
Inclusion Criteria:

* • Subjects aged above 18 years old.

  * Patients should be free from any systemic disease.
  * patients with good oral hygiene
  * completely or partially edenthulus patients

Exclusion Criteria:

* Current and former smokers.

  * Pregnant females.
  * Patients with systemic diseases that may interfere with periodontal condition
  * Uncooperative patients
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate acne vulgaris
* At least 15 inflammatory acne lesions
* Skin phototype I - III
* Able to understand and comply with study requirements

Exclusion Criteria:

* Severe acne vulgaris
* Nodulocystic acne
* Ongoing use of medications and/or treatments for acne
* New hormone regimen (used for less than 12 weeks)
* Significant medical or mental health condition
Effect of a Motivational Intervention on Exercise Adherence After Cardiac Rehabilitation

The Canadian Physical Activity Guidelines recommend that adults should exercise for at least 150 minutes per week. Incorporating 150 minutes of moderate-to-vigorous intensity physical activity (MVPA) a week has been associated with the prevention of at least 25 chronic diseases, including cardiovascular disease. However, most people do not successfully maintain this active behavior. The primary objective of this investigation is to understand what predicts successful exercise adherence and why people dropout from the gym. The long-term impact of this study has implications for future policy level interventions aimed at exercise adherence.

The participants will receive a link to the baseline survey at www.surveymonkey.com. After completing the survey, the participants will be randomized into an intervention or a control group. The intervention group will be invited to attend a group meeting at weeks 1, 6 and 12 (3-month mark) which will take place at the EPIC center. These meetings will help participants create effective goals and methods on maintaining their motivation to exercise regularly. The participants will then receive a monthly phone call follow-up at months 4-6. The purpose of these meeting/follow-ups is to serve as a review of the worksheet, address any questions and help make any modification plans if necessary. Participants in the control group will be simply encouraged to exercise at the EPIC center and complete the online surveys. Participants in the control group will receive the skills/tactics at the end of the study. As members of the EPIC center, all participants will have access to four weekly supervised sesssions for three months.

Eligibility Criteria:
Inclusion Criteria:

* 50 years and older, included in the prevention clinique at Epic Center after an acute coronary syndrome (≤ 12 months) with or without revascularization, doing less than 150 minutes of physical activity per week. The approval of a cardiologist is needed to take part in this program. A normal score on the MoCA (≥ 26) is needed.

Exclusion Criteria:

* Valve surgery without any coronary event, non-cardiopulmonary exercise limitation, stress induce malignant arrhythmia and decompensate heart failure
Comparison of Methods of Lumbar Sympathetic Ganglion Block: Distance vs Angle

Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7\~7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion block.


Eligibility Criteria:
Inclusion Criteria:

1. Adults above age of 20
2. Undergoing lumbar sympathetic ganglion block indication

Exclusion Criteria:

1. Infection
2. Bleeding tendency
3. Previous spinal surgery history
4. Pregnancy
5. Illiteracy
A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation

This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* Has a confirmed diagnosis of relapsed or refractory CLL.
* Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation
* Patient voluntarily agrees to participate in this study and signs informed consent form

Exclusion Criteria:

* Has contraindications to venetoclax as listed on the approved local label in Russian Federation.
* Has Richter syndrome
* Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation
Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility: a Retrospective Study

The goal of this observational study is to assess the effect of complex balneotherapy and physiotherapy treatment among infertile women treated in the Harkany Thermal Rehabilitation Center between July 01, 2007 and December 31, 2021. The main questions it aims to answer are:

* To what extent can the complex balneotherapy and physiotherapy treatment be an effective additional therapy in female infertility?
* What are the clinical changes behind infertility that can be helped by the complex balneotherapy and physiotherapy treatment? Participants will be asked to answer a questionnaire that we have prepared.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Diagnosed primary or secondary infertility

Exclusion Criteria:

* Lack of cooperation
Uniform Communication by Midwives in Preparation for an IVF Treatment

Dutch-speaking women who are about to start an IVF treatment will be approached. If they are willing to participate in the study, they will receive an email with a link to an online questionnaire. This questionnaire will evaluate the communication by the midwive in preparation for an IVF treatment. When 50 women have completed the questionnaire a standardized communication protocol will be enrolled. Once all midwives are trained, 50 other IVF patients will be asked to complete the slightly adapted post questionnaire.The data from both questionnaires will be compared.


Eligibility Criteria:
Inclusion Criteria:

* women who are about to start an IVF treatment at our department

Exclusion Criteria:

* non-Dutch speaking
* women who are counseled by one of the midwives involved in the design of this study
The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

The purpose of this study is to investigate to what extent IOs improve the functionality of edentulous patients and changes in quality of life and overall patient satisfaction following treatment with IOs.

Edentulous individuals will be selected from patients attending the prosthodontic clinic. Then, new complete dentures will be provided; in a second stage half of these subjects (randomly selected) will receive IOs. The effect of different treatment protocols on chewing ability, patient satisfaction and OHRQoL will be investigated and assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Being edentulous in the upper and lower jaw for at least 1 year
2. Dissatisfied or cannot function with their complete lower denture
3. Age between 40 and 75
4. Suitable bone quality as assessed radiographically (CBCT) according to Zarb's classification。

Exclusion Criteria:

1. Physical and mental disabilities which interfere with the maintenance of implants;
2. Severe skeletal jaw discrepancies (class III)
3. Those who have already received or lost dental implants
4. Those who abuse drugs or alcohol
5. Smoking more than 10 cigarettes a day
6. Having received radiotherapy to the head and neck region for malignancies
7. Undergoing chemotherapy
8. On long-term therapy with steroids
9. immunosuppressants or biphosphonates
10. Insulin-dependent diabetic patients and uncontrolled onset diabetic patients
11. Those affected by chronic renal or liver disease
12. Systemic and local bone disorders and pathology
13. Serious cardiac and pulmonary disorders
14. Haemophilic disorders who are susceptible for increased bleeding and tendency for post-operative infections
15. Those who are at risk of developing bacterial endocarditis
16. Immune system compromised patients, including those with HIV
Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin

Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with multiorgan dysfunction syndrome by septic origin.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
* Sepsis of abdominal origin with controlled infectious focus.
* Noradrenaline dose\> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
* Dysfunction of two or more organs with SOFA ≥ 9 (5).
* Blood lactate ≥ 2 mmol / L.
* Procalcitonin (PCT)\> 10 ng / mL.
* CRP\> 100 mg / L.
* IL-6\> 2000 pg / ml.

Exclusion Criteria:

* Age under 18 years or over 80 years.
* Pregnancy or breastfeeding.
* Terminally ill patients or with a life expectancy of less than 48 hours.
* Thrombocytopenia \<60,000 / mm3.
* Pancytopenia.
* Severe coagulopathy with high risk of bleeding.
* Inclusion in another research protocol.
* In case of re-entry during the study period, only the first admission will be included.
* Use of another haemoperfusion device.
Correlation of Angle Kappa , Corneal High Order Aberrations and Total Eye Aberrations in Various Refractive Errors

Identification of the correlation between angle kappa , corneal high order aberrations and total eye aberrations in myopic hyperopic and astigmatic patients

The patient will be thoroughly examined clinically on slit lamp detailed history will be obtained visual acuity will be measured and patient refraction will be taken then imaging on Sirius topographer will be used to obtain angle Kappa and high order aberrations of the cornea and I-design pentacam imaging will be used to get the total aberrations of the eye

Eligibility Criteria:
Inclusion Criteria:

1. Patients with errors of refraction above the age of 18
2. No history of trauma.
3. No other ocular disease .

Exclusion Criteria:

1. patient under age of 18
2. patients with systemic disease.
3. patient with corneal diseases
4. Patient who did any sort of occular surgery
5. patient refusal
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors

Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed "PPI failures." Esophageal pH monitoring studies have shown that PPI failure rarely is due to persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis underlies PPI failure for patients with GERD symptoms.

Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD.

Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to participate in the study. Patients who provide informed consent will have a medical history taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for one week. The patient will return to the clinic one week later. Patients who feel that their heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation. During the endoscopic examination, biopsy specimens will be taken as follows: A. Two specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made if there is at least one high-power field with \>25 eosinophils, or two or more high-power fields with \>15 eosinophils.

Potential Benefits: This study will provide an estimate on the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD. This has substantial potential importance for patient management.


Eligibility Criteria:
Inclusion Criteria:Male and female patients ages 18 years and older who are referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy

Exclusion Criteria:

1. Patients unwilling or unable to provide informed consent.
2. Allergy to lansoprazole.
3. Patients taking warfarin.
4. Coagulopathy that precludes safe biopsy of the esophagus.
5. Comorbidity that precludes safe participation in the study.
6. Pregnancy.
Linking Former Inmates to Primary Care

The Transitions Clinic Network (TCN)aims to connect former inmates to primary care using trained, culturally competent primary care providers and community health workers (CHWs). The purpose of this project is to support ongoing quality improvement at the 13 participating sites by training culturally competent CHWs and measuring the health, health care utilization, and the costs of caring for former inmates.

The Transitions Clinic Network (TCN) is a network of 13 community-based transitional healthcare programs, which aim to improve health, improve health care, and lower costs for vulnerable, high-risk Medicaid patients returning from prison across the United States. The TCN aims to connect individuals released from prison to primary care using trained, culturally competent primary care providers and community health workers (CHWs). The providers and CHWs, help patients obtain timely healthcare; promote healthy reintegration into their communities; provide care coordination and chronic disease management; and prevent unnecessary emergency department utilization and hospitalizations.

The project supports ongoing quality improvement at each of the 13 clinical sites by measuring the health, health care utilization, and the costs of caring for recently released patients. We will prospectively examine the rates of primary care engagement, acute care utilization, substance abuse and reported health, and recidivism in a cohort of 2000 patients recently released from prison receiving primary care at the 13 TCN programs. We will compare these rates of utilization at 6, 12, 18, 24, 30, 36 months to patient self-reported utilization prior to incarceration and historical controls.

Additionally, we aim to describe the implementation of, fidelity to, and sustainability of the TCN model in each of these clinical programs. Specifically, we aim to capture assets and barriers to starting and sustaining primary care programs targeting returning prisoners.

Eligibility Criteria:
Inclusion Criteria:

* Recently-released from prison (within one month)
* Has \>=1 chronic disease condition , and/or age \>=50 years
* Plans to live in the TCN area for the duration of the study
* Understands English or Spanish and able to provide consent

Exclusion Criteria:

* Does not plan to live in the TCN area for the duration of the study
* Does not understand English or Spanish, or unable to provide consent
* Does not plan to receive healthcare through a TCN clinic