cyrilzakka/clinical-trials huggingface dataset:
Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine

This prospective study aims to investigate the effects of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with Clozapine.

The first developed atypical antipsychotic is clozapine. Its efficacy has been demonstrated in individuals with schizophrenia who have insufficient response to other antipsychotic therapies; nonetheless, its adverse effect profile is extensive. Among the antipsychotic medications now available, clozapine is not utilized as a first-line therapy because of major side effects such agranulocytosis. Increased salivation, sleepiness, weight gain, changes in blood pressure (sometimes an increase, sometimes a drop), elevated heart rate, dizziness, exhaustion, constipation, fever, and nocturnal enuresis are common adverse effects of clozapine usage.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated who were diagnosed with schizophrenia according to DSM-V criteria by psychiatrist at the Turkish Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital
* using a therapeutic dose of 300-500 mg/day of clozapine,

Exclusion Criteria:

* pregnancy
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia

The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.

This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18-79 inclusive
* Fasting, untreated low-density lipoprotein cholesterol (LDL-C)level in the borderline high to very high range
* Fasting, untreated triglyceride (TG)level in the normal range
* Provide written informed consent and authorization for protected health information

Exclusion Criteria:

* CHD or CHD risk equivalent
* Pregnancy
* Use of lipid altering medications which cannot be stopped
* Body mass index over 45 kg per square meter
* Allergy or sensitivity to omega-3 fatty acids
* Certain muscle, liver, kidney, lung or gastrointestinal conditions
* Poorly controlled hypertension
* Certain medications
* Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer

In this study the investigator will compare the effectiveness of robot assisted thoracic surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer.

The perioperative circumstances and postoperative outcome will be compared.

Participants are randomly subdivided (1:1) to either undergo robot assisted lobectomy or video assisted thoracoscopic lobectomy in case of lung cancer. At the end of both surgical interventions the anaesthesiologist administers the same technique of pain relief: paravertebral blockage.

The data that are going to be investigated are: operative time, conversion to spreading of the ribs/thoracotomy, blood loss, lymph node dissection, prolonged air leak, chest tube drainage, length of stay, inflammatory reaction (through inflammatory parameters CRP, IL-3, IL-6, TNF), lung recuperation (through a lung function test) and postoperative pain (VAS score questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years old or older
* Patients can be male or female
* Patients with a lung tumour which is treatable with surgery

Exclusion Criteria:

* Pregnancy
* Inoperable lung tumour
* Patients which are at risk for general anaesthesia
Personalized Medicine in Patients With Infective Endocarditis

The hypothesis underlying this work is the identification of different sub phenotypes of patients with infective endocarditis through the study of the host's response to infection.

Furthemore, metagenomic sequencing may be a helpful supplement to IE diagnostic, especially when conventional tests fail to yield a diagnosis.

Infective endocarditis is a life-threatening infection of heart valves and adjacent structures characterized by vegetations on valves and other endocardial surfaces, with tissue destruction and risk of embolization.

The clinical variability, including the heterogeneous response to infection and the different antibiotic treatments make the identification of the underlying pathogens of infective endocarditis (IE) is critical for precision therapy. Virulence factors mediate tissue adherence, host infiltration, immune resistance/evasion, and dynamic stress responses and confer enhanced pathogen survival, proliferation, and host invasion in animal models of infective endocarditis.

To identify the microorganism and simultaneously considered the response of the host to the infection could improve the management of the infective endocarditis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of active infective endocarditis according to the modified Duke criteria.

Exclusion Criteria:

* Pregnancy
Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO)

With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still largely unclear. A number of differential diagnoses are possible, including inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided. The major issue is whether or not the doctors should treat these patients at all or wait until the first sign of a solid lesion developes which may take many years.

The purpose of this study is to determine if the ablation therapy is safe and effective for the pulmonary pGGO.


Eligibility Criteria:
Inclusion Criteria:

* The lesion(s) treated with ablation must be =\< 2.0 cm in greatest dimension
* All patients are required to have been evaluated in a multi-disciplinary tumor conference to ensure that the lesion is suitable for Image-guided percutaneous ablation
* Platelet count ≥ 100 x 109/L
* International normalized ratio (INR) \< 1.5
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* A signed study specific consent form is required

Exclusion Criteria:

* Direct evidence of regional or distant metastases,or synchronous primary or prior malignancy in the past 5 years
* Unable to lie flat or has respiratory distress at rest
* Uncontrolled coagulopathy or bleeding disorders
* Evidence of active systemic, pulmonary, or pericardial infection
* Women who are pregnant or breastfeeding
* Patients with poor pulmonary function
The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole)
* Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast

Exclusion Criteria:

* Pregnant female
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
* Abnormal blood chemistries: Bilirubin \>2 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 4 times the upper limit of normal
* Less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents
* Patients taking other systemic antifungal therapies while on this study
Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Has either type 1 or type 2 diabetes
* Has intact feet as defined by the absence of a skin breakdown below the malleoli.
* Has neuropathy confirmed by impaired sensation to neurothesiometer (vibration perception threshold \> 25 volts on one OR both feet)
* Has a past history of ≥1 foot ulceration (s) which has (have) resolved in the last 3 months
* Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
* Has no history of peripheral arterial disease
* Has footwear which in the opinion of the investigator is not likely to cause pressure damage
* Must be able to provide meaningful written informed consent for the study

Exclusion Criteria:

* Is aged \<18
* Has foot deformity that in the opinion of the investigator would interfere with the interpreting of the results of the study.
* Has previous history of foot surgery which in the opinion of the study investigator could interfere with the interpreting the results of the study
* Has active foot ulceration and infection
* Has active Charcot osteoarthropathy
* Has established Charcot foot deformity that in the opinion of the study investigator would interfere with the interpreting of the results of the study.
* Has any uncontrolled illness that, in the opinion of the study investigator, would interfere with interpreting the results of the study
* Has an implantable electronic device
Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors

The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.

Besides the main objective, there are 4 other objectives as follows:

1. To determine dose-limiting toxicity (DLT) of HM781-36B
2. To determine Maximum Tolerated Dose (MTD) of HM781-36B
3. To determine the effect of food on the pharmacokinetics after dosed HM781-36B continuously
4. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced solid tumor
2. Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
3. Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
4. Aged ≥19
5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
6. A life expectancy greater than 12 weeks
7. Adequate bone marrow, renal and liver function.
8. Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

1. Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.
2. Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
3. Patients who have GI malabsorption or difficulty taking oral medication
4. Patients who have psychiatric or congenital disorder
5. Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
6. Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study

Researchers of the three collaborating universities implement a pilot observational study in "Gilgel Gibe Field Research Center", a health and demographic surveillance system run by the Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in young men for the development of common mental disorders and psychotic symptoms and the stability of distinct symptoms of mental disorders in the community. The investigators will explore in particular the impact of lifestyle on mental health in young men, including the traditional habit of chewing khat leaves, which contain amphetamine-like cathinone. Furthermore, the investigators want to demonstrate the reliability and validity of assessments performed by trained local interviewers.


Eligibility Criteria:
Inclusion Criteria:

* Male, Age 18 - 30, permanent residents in Gilgel Gibe

Exclusion Criteria:

* Prior existing severe mental health problems
Parenting Mindfully Study

The goal of study is to develop and test a parenting-focused version of mindfulness intervention ("Parenting Mindfully") to reduce parent stress and prevent adolescent substance use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that Parenting Mindfully (PM) will decrease prevent adolescent substance use and HIV risk behaviors and intentions. Secondarily, PM will improve parenting, and decrease adolescent stress responses.


Eligibility Criteria:
Inclusion Criteria:

1. Family with a child between 12-16 years;
2. High parenting stress (mean score of \>=3 on 2 questions adapted from the Perceived Stress Scale and the Parenting Stress Index).

Exclusion Criteria:

1. Diagnosis of mental retardation, autism or other pervasive developmental disorder for adolescent;
2. Current serious psychiatric or medical disorder (including current substance dependence) requiring immediate treatment for adolescent or parent- We will include those that are in treatment;
3. Medical condition that would preclude participation in gentle yoga (for parents)
4. Inadequate English proficiency to complete questionnaires for youth or parents.
A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)

This multicenter, retrospective and prospective observational, cohort study will examine the effect of second-line Tarceva treatment on long response in non-small cell lung cancer (NSCLC) participants with wild type or unknown EGFR status. Participants will be observed from the start of treatment for 8 months or until death. The extension of the retrospective versus prospective observation will depend on the lag between the date of the participant enrollment and the date of beginning of erlotinib therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants with stage IIIb or IV NSCLC
* Participants aged \>/= 18 years
* Second-line treatment with Tarceva started before study inclusion and SD response, or CR/PR according to RECIST v1.1, lasting for at least 4 weeks

Exclusion Criteria:

* Known presence of epidermal growth factor receptor (EGFR) mutation
* Participation in a clinical trial with Tarceva during the study observation period
A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3

To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.

Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm.

PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* PCP prophylaxis, M. tuberculosis prophylaxis, short courses of acyclovir, chronic suppressive acyclovir, pneumovax or Hib vaccine, antibiotics, rEPO and G-CSF for grade 3 or worse anemia and neutropenia, systemic corticosteroids for \< 21 days, regularly prescribed medications, and vitamins or herbal therapies.

Patients must have:

* HIV infection without AIDS with CD4 200-500 cells/mm3.

PER AMENDMENT 4/5/95:

* Patients must have remained on ACTG 175 study treatment through 4/30/95 and meet toxicity management criteria for continuing treatment. Subjects taking ACTG 175 crossover treatment are eligible.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Current AIDS-related condition other than minimal KS, grade 2 or worse peripheral neuropathy, and malignancy requiring systemic therapy.

Concurrent Medication:

Excluded:

* Other anti-HIV drugs, biologic response modifiers other than rEPO and G-CSF, systemic cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects AZT glucuronidation or clearance.

Concurrent Treatment:

Excluded:

* Radiotherapy other than limited local therapy to skin.

Patients with the following prior conditions are excluded:

* AIDS-related condition other than minimal KS; intolerance to AZT, ddI, or ddC at study doses; and acute or chronic pancreatitis.

Prior Medication:

Excluded:

* Acute therapy for an infection or other medical illness within the past 14 days.

Current alcohol abuse.
Methotrexate Treatment for Ectopic Pregnancy

Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality. Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic pregnancy. The main stays of management for ectopic pregnancy were surgery and medical treatment. Medical management with systemic methotrexate administration avoids the inherent morbidity of anesthesia and surgery is cost-effective, and also offers success rates comparable to surgical management, with no loss in future potential fertility.

However, although medical management using methotrexate is used commonly, there is no solid consensus regarding dose protocol. Currently, there are three methotrexate protocols for the treatment of an ectopic pregnancy, "multi-dose", "single-dose", or "two-dose". Among them, the multi-dose protocol includes the administration of 4 methotrexate doses alternating with leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side effects are more common. In contrast, the advantages of the single-dose protocol include elimination of a rescue regimen, lower incidence of adverse effects, and better compliance. However, the single-dose protocol was found to be associated with a considerably lower success rate as compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. The two-dose protocol, which it balances efficacy and safety/convenience, was described as a cross between the multi-dose and single-dose protocols.

However, there were a few studies comparing between single-dose and two-dose protocol. The purpose of this prospective randomized trial was to compared the success rates of single-dose and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* tubal pregnancy
* tubal pregnancy except interstitial pregnancy
* a pretreatment β-hCG level \<15000 mIU/mL
* a gestational sac with a largest diameter \<4 cm
* hemodynamically stable status
* agreement to methotrexate treatment and follow up

Exclusion Criteria:

* heterotrophic pregnancy
* a presence of embryonic cardiac motion
* clinically or sonographically suspected tubal rupture
* laboratory tests showing possible deleterious effects of methotrexate treatment on organ functions
Single Tooth Extraction in Damaged Alveoli and Implant Site Development:TootToo

It is unclear what is the best approach to implant site development after tooth extraction when the pathology leading to extraction has damaged the alveolus. The main objective of this study is to assess if socket preservation and/or reconstruction surgery provides a clinical benefit in terms of ability to place an implant in a prosthetically guided position in such clinical conditions.

The PICO question therefore is:

In patients requiring single tooth extraction what is the benefit of socket preservation/reconstruction surgery with respect to spontaneous healing in terms of feasibility and ease of implant surgery?

This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, clinical trial.

The statistical design will be a superiority trial in terms of the primary outcome with reference to the standard of care control (spontaneous healing).

Primary outcome:

Possibility to place an implant in a prosthetically driven position with or without bone or soft tissue augmentation 16-20 weeks after tooth extraction, evaluated at planning with cone beam CT and confirmed at surgery.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy. No contraindications to elective oral surgery
* All pathologies requiring single tooth extraction with adjacent teeth (or implant) with the presence of at least one third of the alveolus.
* Evidence of subject ability to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS\<25% and FMBS\<25%)
* Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give informed consent.

Exclusion Criteria:

* Presence of frank purulence or acute abscess at the time of extraction
* Presence of bone resorption of one or more walls of the alveolus extending to the apical third of the socket
* Self reported current smoking exceeding 20 cigarettes/day or pipe or cigar smoking
* Presence of medical contraindications to elective surgery