cyrilzakka/clinical-trials huggingface dataset:
Precision Transcranial Magnetic Stimulation for Patients With Post-stress Sleep Disorders

This is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation

This is a randomized, double-blind controlled study that will recruit patients who have experienced a stressful event and currently exhibit severe sleep problems for transcranial magnetic stimulation. They will be randomly assigned to the trial and control groups and will receive 5 consecutive days of continuous theta-wave stimulation, and before and after the treatment they will be assessed on clinical scales and undergo magnetic resonance examinations as well as sleep monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Be between the ages of 18 and 60 (both 18 and 60) and of any gender;
2. Experienced a severe traumatic event;
3. Stanford Acute Stress Reaction Questionnaire (SASRQ) ≥40 points;
4. PSQI \> 7 points;
5. Good compliance and willingness to undergo this therapy.

Exclusion Criteria:

1. Sleep disorders that can be explained by a primary illness;
2. Concurrent psychotherapy;
3. Those with contraindications to magnetic resonance examination and transcranial magnetic stimulation therapy;
4. Combined with serious cardiovascular, hepatic, renal, digestive, hematopoietic system and other primary diseases.
Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

Clinical background: Weight loss is a common problem in patients suffering from gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with weight loss is worse than that for weight stable patients. Malnutrition in cancer patients is associated with a poor prognosis and is an important predictor of mortality. Supplementation with home parenteral nutrition in aphagic and terminal patients has shown improved quality of life, energy balance, body composition and prolonged survival.

Aim: The aim of this study is primarily to study the effects of supplementation with parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean body-mass and body composition. Patients found to be at nutritional risk will be included in the study and will be randomized to either best supportive nutritional care or best supportive nutritional care and supplemental Parenteral Nutrition.

Design: This study is a controlled, randomized trial with two parallel study arms. The study will include patients with advanced GI cancers at nutritional risk, performance status 0-2 and with an expected survival of a minimum of 3 months.

A total of 100 patients are planned to be enrolled and randomized to either best supportive nutritional care or best supportive nutritional care and supplemental parenteral Nutrition.

Primary endpoint is improvement of lean body mass, and by that improvement of quality of life, performance status and cancer treatment tolerance.

Discussion: The planned study will provide important information about the effect of parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative treatment strategies are set up to improve quality of life as well as prolongation of life. Parenteral nutrition in this patient group may indeed contribute to both these aspects of palliation.

Randomizing. The patients will be enrolled in the study, by block randomizing using a computer generated list, stratifying in respect to performance status 0 and 1 in opposite to PS 2 for the first 10 patients enrolled in the study.

To make the two treatment groups comparable, the patients number 11-100 enrolled in the study will be placed in the treatment groups using the minimization method. Using the minimization method the prognostic factors for age, diagnosis and performance status at the enrollment, will be considered to make the treatment groups similar.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-resectable GI-Cancer
* at nutritional risk; having lost 5% of body weight during the previous 3 months or has failed to reach intake by 25% in the last 2 weeks.
* At performance status 0-2
* Life expectancy more than 3 months.
* Age over 18 years old.
* Able to give written consent

Exclusion Criteria:

* Gastrointestinal obstruction or failure.
* Immune deficiency diseases (apart from the cancer disease. )
* Current infection or sepsis.
Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients

1. Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis.
2. Explore the related factors of the smoking change patterns.
3. The type of smoking trajectory impact on survival and quality of life.

This was a prospective longitudinal design study. The investigators used the structure questionnaires to collect the data from a consecutive sample of newly diagnosed lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old
* Newly diagnosed lung cancer
* Conscious clear and able to communicate
* Agreed to participate the study

Exclusion Criteria:

* Consciously confused
* Cognitive or psychotic disorders
Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.

PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.

OBJECTIVES:

* Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
* Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
* Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.

OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.

Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.

Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.

Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.

PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR
* Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
* Refused whole brain radiation therapy OR
* Received prior whole brain radiation therapy and ineligible for other relapse protocols
* 18 and over
* Karnofsky 60-100%
* Life expectancy:At least 3 months
* Concurrent steroids allowed

Exclusion Criteria:

* more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
* more than 2 weeks since prior focal radiation
* more than 2 weeks since prior focal surgery
Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality

This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta endorphin levels, pain levels and sleep quality.

While there are studies conducted with laughter yoga on different patient groups in Turkey, no studies have been found on hemodialysis patients specifically. For this reason, it was thought that studies are needed which will prove the effect of laughter yoga practices on the plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* receiving treatment in a dialysis center
* must be between 18 and 80 years old and willing to participate in the study
* receiving HD treatment at least twice a week for a month or longer
* having a pain level and above
* level of 5 above according to the Pittsburgh Sleep Quality Index.

Exclusion Criteria:

* not taking any medicine for sleeping disorder
* not having any visual, hearing or communication impairments
* not having any mental disorders
Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor

Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.

The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications.

Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have premalignant lesions.
* Lesion sites include oral cavity, oropharynx, and larynx.
* Must have at least a \>20 pack-year history of smoking.
* Must have a Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1.
* Participants must be 18 years of age or older.
* No contraindications for laryngoscopy and biopsy.
* Adequate liver function.
* Must have hemoglobin and hematocrit levels at or above the lower limit of the normal range.
* Participants must have prothrombin time (PT)/partial thromboplastin time (PTT) levels at or above the lower limit of the normal range.
* Women of child-bearing potential must have a negative serum pregnancy test within 72 hours of receiving treatment.
* Must be able to swallow the oral dose of erlotinib and celecoxib.
* Participants must be disease free.
* Final eligibility will be determined by the health professionals conducting the trial.

Exclusion Criteria:

* Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
* History of previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year.
* Pregnant or breast feeding.
* Not practicing adequate contraception if the participants are of child bearing potential.
* Female patients who have a positive pregnancy test.
* History or recent myocardial infarction.
* Hypertension not adequately controlled by medication.
* Documented history of coagulopathy.
* Documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Grade II.
* Participants who were taking COX-2 inhibitors or EGFR tyrosine kinase inhibitors within 3 months of study entry.
* Documented history or interstitial lung disease.
* Known connective tissue disease.
* History of nonsteroidal antiinflammatory drug (NSAID)-induced ulcers or those who are at risk for a GI ulcer.
* Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
* Final eligibility will be determined by the health professionals conducting the trial.
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.


Eligibility Criteria:
Inclusion Criteria:

* HIV+
* Ages 18-70
* HIV-1 RNA \<400 copies/ml.
* On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos.

Exclusion Criteria:

* Active infection
* Inflammation or malignancy
* Uncontrolled diabetes or hypothyroidism
* LDL (low density lipoprotein) cholesterol \>160 and triglyceride levels \>750
* Framingham risk score \<6.
Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, including males and females;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
* Life expectancy of ≥3 months;
* Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
* For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
* Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
* Ability to swallow oral medications;
* Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;

Exclusion Criteria:

* Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
* Known impaired cardiac function or clinically significant cardiac disease
* HIV infection;
* Failed to recover from the reversible effects of prior anticancer therapies:
* Pregnancy (positive serum or urine pregnancy test) or breast feeding;
* Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;
Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology

Exclusion Criteria:

* Have any current primary Axis I diagnosis other than major depressive disorder
* Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
* Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
* Have regional pain syndrome, multiple surgeries or failed back syndrome
* Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)
Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer

In the first phase of the study a respiratory physician was trained to perform neck ultrasound and needle sampling of enlarged cervical lymph nodes according to preset criteria. In the second phase patients with suspected lung cancer and enlarged mediastinal lymph nodes underwent routine neck ultrasound and enlarged cervical lymph nodes were sampled using fine needle and or core needle biopsy.

The outcomes of interest in the study were the rate of malignant cervical lymphadenopathy defined as pathological evidence of cancer in neck lymph node samples consistent with a lung primary, adequacy of needle sampling, patient reported experience assessed by a visual analogue of discomfort associated with needle neck sampling and EBUS, and the proportion of patients that had nodal upstaging

Eligibility Criteria:
Inclusion Criteria:

* Suspected and later on confirmed lung cancer
* Presence of at least one mediastinal lymph node measuring \> 10 mm in short diameter on computerised Tomography

Exclusion Criteria:

* Age \<18
* History any malignancy apart from non-melanomatous skin cancer
* Inability to give informed consent
Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes

An emerging body of epidemiological evidence suggests that various forms of sedentary behavior, including TV viewing, occupational sitting, and total daily sitting, may be associated with all-cause and cardiovascular mortality, overweight and obesity, type 2 diabetes, depression and psychological well-being. Importantly, many of these associations were independent of participation in moderate to vigorous intensity physical activity. We propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of two interventions targeting sedentary behavior. Since it is currently unknown what component of sedentary behavior exposure presents the greatest risk to health, we propose separate interventions to reduce overall sedentary time and to promote breaks in sedentary time.

Primary aim: To determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day.

Secondary aim: To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior.

Exploratory aim: To establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g. decreased overall sitting time or increased number of breaks in sitting).

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 50 -70 years of age
2. Able to attend 4 measurement visits with study staff in 3 consecutive weeks
3. Spend at least 8 hours per day sitting
4. Willing and able to wear study device for 21 days
5. Able to read and write in English
6. Able to provide written informed consent

Exclusion Criteria:

1. Do not sit for at least 8 hours per day
2. Unable to attend 4 visits
3. Diagnosis of serious chronic condition that would limit the ability to stand
Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus

Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.

Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG


Eligibility Criteria:
Inclusion Criteria:

* patients aged 16 years and above
* with hepatitis B virus infection

Exclusion Criteria:

* patients with HIV or HCV co-infection
Autologous Serum Efficacy Study in Patients With Severe Dry Eye

The purpose of this study is to compare the reduction in symptomatology of patients with severe dry eye treated with autologous serum and conventional artificial tears.

Severe dry eye remains an important and frequent eye disease, that reflects in a severe impairment of the patient´s life quality. Up to date there is no ideal therapy for this condition. Few studies have reported some kind of improvement in different parameters related to dry eye with the use of autologous serum, but no one has considered the patient´s symptoms with a systematic and validated evaluation method.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Severe Dry Eye, as defined by a OSDI score \> or = 40

Plus:

* Tear Break Up Time (TBUT) \< 5 seconds
* Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score.

Exclusion Criteria:

* No dry eye associated ocular disease
* Unable to comply protocol
* Severe anemia
* Previous use of autologous serum
* Concomitant use of other topical ocular drug
* Hypersensibility to any proposed interventions
Efficacy Transverse Abdominal Plane (TAP) Block Renal Transplant Surgery

The objective of this study is to evaluate the efficacy and safety of transverse abdominal plane block in patients undergoing renal transplant surgery.Adult renal transplant recipients will be prospectively randomized to receive a standard general anesthetic technique supplemented with ropivacaine 0.375% 20 mL TAP block or sham block with 20 mL 0.9% saline. Both groups will receive patient-controlled morphine analgesia. Patient assessment will occur in the postanesthetic care unit and at 1, 2, 4, 6, 12, and 24 hours. The primary outcome is total morphine consumption in the first 24 hours after renal transplantation. Other outcomes asses include pain scores, presence of nausea or vomiting, excessive sedation, and respiratory depression.


Eligibility Criteria:
Inclusion Criteria:

* end-stage renal disease undergoing cadaveric renal transplantation

Exclusion Criteria:

* Contraindications to the use of morphine
* Contraindications to the use ropivacaine
* Peripheral neuropathy
* Inability to use a Patient Control Analgesia device
Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI

The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.

Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication.

Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed

Eligibility Criteria:
Inclusion Criteria:

* undergoing PCI with stenting for all clinical indications
* carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2 (evaluated through MDRD); ù
* younger than 85 years old.

Exclusion Criteria:

* ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;