cyrilzakka/clinical-trials huggingface dataset:
Narrative Exposure Therapy in Women With Borderline Personality Disorder and Posttraumatic Stress Disorder

Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims are the reduction of PTSD-Symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. This practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. The investigators assume that using NET the reduction of PTSD symptom severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* DSM-IV-TR diagnoses of BPD and PTSD
* legal competence
* none or stable medication
* illegal drug abstinence for at least the last 6 months
* capacity to consent and contract

Exclusion Criteria:

* other severe mental disorders (e.g., bipolar disorder, acute psychosis)
* simultaneous consumption of drugs
* simultaneous participation in other treatment-studies
* pregnancy or breastfeeding
* lack of capability to negotiate a no-suicide agreement
* suicide attempt or attempts during the 8 weeks prior to start of treatment
* perpetrator-contact
* Body Mass Index (BMI) \< 16
Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas

The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed intracranial Grade 1 or 2 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma).

Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered.

Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.

Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.

At least 18 years old. Both men and women must practice adequate contraception. Informed consent.

Exclusion Criteria:

Progressed while on temozolomide. Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1. Not recovered from the toxic effects of prior therapy. Pregnant or breast feeding. History of diabetes mellitus. Uncontrolled intercurrent illness. Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.

HIV positive. Diagnosis of another malignancy may exclude subject from study.
Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain

The aim of the study was to compare the effects of different manual therapy approaches on pain, cervical range of motion, balance, functional status and life quality in patients with chronic neck pain.

Various physiotherapy and rehabilitation methods are applied in the treatment of patients with chronic neck pain. Clinical practice guidelines for individuals with chronic neck pain recommend both manual therapy and exercise therapy among conservative treatments. Manual therapy are methods that can be safely applied to soft tissues and joints. Both manual therapy and exercise applications have been shown to have positive effects on neck pain and function. Some studies in the literature have also shown that manual therapy methods have positive effects on balance. However, no study examining the effects of different manual therapy (classical massage, connective tissue massage, manual joint techniques) approaches applied to individuals with chronic neck pain on pain, cervical range of motion, balance, functional status and quality of life was found in the literature.

Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-65.
* To participate in the study voluntarily.
* Having a complaint of neck pain for at least 3 months.

Exclusion Criteria:

* To have undergone cervical spine surgery
* Having cervical fracture and/or joint subluxation/dislocation
* Severe degenerative arthritis
* Having a neurological disease (Parkinson's disease, poliomyelitis, etc.) or an -inflammatory rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, etc.)
* Presence of malignancy
* Having cord compression and signs
* Severe radiculopathy or myelopathy
* Positive vertebrobasilar artery test,
* Pregnancy
Effect of Korean Red Ginseng (KRG) on Dry Mouth

The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).

Korean Red Ginseng

* Worldwide use
* A main herb of old oriental prescriptions for dry mouth
* Need for correct information by RCT

Eligibility Criteria:
Inclusion Criteria:

* Dry mouth patients

Exclusion Criteria:

* Sjögren syndrome
* Irradiation related xerostomia
* Severe psychiatric diseases
* pregnancy or breast feeding women
Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome

The investigators aim to assess the respiratory effect of short half-life agents in balanced anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane versus a regimen of fentanyl-sevoflurane. Each patient will undergo three respiratory portable polygraphies: the night before the surgery ; the first night following the surgery ; the third night following the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Physical status I - III
* Patient scheduled to undergo lower limb orthopedic surgery
* Patients known for non-treated obstructive sleep apnea or suspected of having an obstructive sleep apnea

Exclusion Criteria:

* Patients known for treated obstructive sleep apnea ;
* Severe respiratory disease (i.e., chronic obstructive pulmonary disease, asthma, pulmonary fibrosis);
* Severe cardiovascular disease
* Chronic use of opiates ≥ 30mg/j morphine eq.
* Chronic use of benzodiazepine
* Inability to consent
* Refusal
Effect of Blueberries on Immunity and Response to Flu Vaccination

This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight older men and postmenopausal women

A free-living parallel, single-blind, RCT will be utilized. There will be two phases: Phase 1 - to examine the effects of Blueberries on plasma markers of immune strength, and Phase 2 - to assess the response to influenza vaccine following blueberry intake. Subjects will either consume their usual diet with (Blueberry group) or a placebo(control group) blueberries for 8 weeks, receive the influenza vaccination, and continue the intervention for another 4 weeks. The test food will be freeze-dried powder (FDP) (\~ to 1 cup fresh blueberries) per day with the usual diet. The control will be the placebo powder with some guidelines to restrict all berries and other polyphenol-rich foods. The entire study will last 12 weeks. Participants will attend a baseline clinic at which time they will be randomized to one of the two groups. Clinic visits will occur at baseline, weeks 4 and 8 before, and week 4 after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Older men and post-menopausal women aged 50-70 year 2. Have BMI of 25-32 3. Able to commute to Loma Linda University 3. Not taking medication or supplements that affect immunity 4. Agree to get vaccinated for Flu

Exclusion Criteria:

1. Intolerance or allergy to Blueberries
2. Regular intake of Blueberries and other berried (\>2 ounces/week)
3. Immune system insufficiency or disease
4. Using immune boosting supplements
5. Exposure to antibiotics and corticoids immediately prior to study
6. Uncontrolled chronic diseases and relevant psychiatric illness, including major depression
7. Flu vaccination less than 10 months ago from the start of the study
Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers

The aim of the study is to assess the accuracy of shear wave elastography in volunteers. Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained using an ultrasound machine. It may be easier to think of shear wave elastography as a special type of ultrasound imaging which gives doctors a colour picture of body structures based on their stiffness.

Shear wave elastography is a quantitative ultrasound modality increasingly used to differentiate between "hard" breast cancer masses and "soft" normal tissue. Unlike strain elastography, shear wave elastography applies a non-compressive longitudinal acoustic radiation force to underlying tissues, inducing transverse shear waves. Studies in Thiel embalmed human cadavers have shown significant differences in Young's modulus between intraneural and extraneural tissue, and ready colour differentiation between tissues.

Therefore, before clinical application, we wish to measure the repeatability and reproducibility of Young's modulus of intraneural and extraneural tissue in volunteers. For measurement, a region of interest (ROI) will be selected over the appropriate nerve and adjacent tissue. The ROI results will be regarded as paired data. Paired data will be measured over and adjacent to the interscalene C5 nerve root, infraclavicular lateral cord, musculocutaneous, median, femoral, saphenous and sciatic nerves.

Eligibility Criteria:
Inclusion Criteria:

* Fit healthy male volunteers between 18 and 35 years of age.
* Participants with an ASA score of 1.
* Capacity to provide informed consent.

Exclusion Criteria:

* All females.
* Male participants aged \<18 years and \>35 years of age.
* ASA score 2 or above.
Morphine Consumption in Thoracotomy

Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. With the use of ultrasound, many regional anesthesia techniques were described to provide effective postoperative analgesia. The aim of this study was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane block (ESPB) in thoracotomies.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients undergo elective thoracotomy surgeries.

Exclusion Criteria:

* Obesity (BMI \> 35 kg/m2)
* Infection of the skin at the site of the needle puncture area
* Patients with known allergies to any of the study drugs
* Coagulopathy
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCl as adjunctive therapy in children and adult participants with LGS.

The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males or females, ages ≥2 to ≤55 years, at the time of Screening.
2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
3. Diagnosis of LGS, including:

   * Evidence of at least one type of countable major motor seizure.
   * History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\<2.5 Hz\], or 2) paroxysmal fast activity during sleep).
   * Abnormal cognitive development.
   * Onset of seizures at 11 years of age or younger.

Key Exclusion Criteria:

1. Known sensitivity, allergy, or previous exposure to clemizole HCl.
2. Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial infarction, clinically significant arrhythmia).
3. Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
4. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control.
5. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
6. Concomitant use of fenfluramine.
7. Prior or concomitant use of lorcaserin.
Melatonin and Sleep Spindles in Autism

Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with ASD
* 12-18 years of age
* English speaking
* Able to understand and respond to questionnaires in English

Exclusion Criteria:

* Pregnant or breastfeeding
* Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)
* Chronic medical conditions that affect sleep
* Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
* History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
* IQ \<70
* Other neurological disorder, including seizure disorder
* Diagnosed sleep disorder
* Known genetic causes of ASD
* Currently taking melatonin or those who have had an adverse reaction to melatonin in the past
Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy

Stereotactic radiotherapy (SRT) is being widely accepted as a treatment of choice for patients with a small number of brain metastases and an acceptable size, allowing a better target dose conformity resulting in high local control rates and better sparing of organs at risk. Currently, imaging for such a delivery technique requires both a recent magnetic resonance imaging (MRI) brain study for volume definition and a computed tomography (CT) scan for SRT planning. An MRI-only workflow could reduce the risk of misalignment between the two imaging modalities and shorten the delay of planning. Given the absence of a calibrated electronic density on MRI, the investigators aim to assess the equivalence of synthetic CTs generated by a generative adversarial network (GAN) for planning in the brain SRT setting.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* SRT treatment for one or more brain metastasis(ses)
* brain MRI and planning CT scans realized less than 14 days prior to the treatment delivery

Exclusion Criteria:

* MRI's field of view (FOV) judged insufficient for tumour(s) and OAR visualization
Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD

MAFLD is a growing problem in India. Its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is the cornerstone of management. The ideal macronutrient distribution within a hypocaloric diet is not known yet. Evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.

Novelty: First study to assess the effect of high protein diet (HPD) in comparison to a standard protein diet (SPD) within a calorie restricted diet, on both the cellular and systemic bioenergetics in patients with MAFLD.

Objectives: Aims to see the effect of HPD on hepatic steatosis, cellular and systemic bioenergetics, along with metabolic parameters in patients with MAFLD.

Method: In this RCT, patients with MAFLD (n=140) with or without MS, would be randomized into HPD or SPD groups (i.e. 70 in each group), and parameters like hepatic steatosis (CAP by Transient elastography (FibroScan), cellular bioenergetics by oxygen consumption rate (OCR) and extracellular acidification rate (ECAR) as measured using Seahorse Analyzer, and Indirect Calorimetry will be used to assess the fasting and postglucose challenge (Oral glucose tolerance test) REE and RQ. DEXA scan would be used to assess body composition apart from routine blood tests to assess features of Metabolic syndrome. The serum levels of GLP1, CKK, Ghrelin, FGF21, Adipokines like leptin and adiponectin, NADH/NAD ratio, insulin and glucagon would be measured.

Outcome: A HPD is expected to improve hepatic steatosis, blunted fuel switching (RQ) and cellular bioenergetics (OCR) along with metabolic parameters in patients with MAFLD.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP \>250, BMI\>23 and/or DM) Age 18-65 years

Exclusion Criteria:

* • Lean (BMI \<23) patients

  * Age \<18 and \>65 years
  * Individuals who had been hospitalized with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months
  * Patients with viral hepatitis
  * Patients with significant alcohol consumption (regular consumption of \> 10g per day for females and \> 20g/d in males),
  * Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded
  * Pregnant \& lactating women
Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
* No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

* Small cell or carcinoid lung cancer
* Known Central Nervous System (CNS) metastasis
* Pre-existing auto-immune or antibody mediated diseases
Diurnal Variation in Hypertensive Stroke Patients

This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).


Eligibility Criteria:
Inclusion Criteria:

1. aged 35 to 85 years
2. hypertensive patients who had an ischemic stroke

Exclusion Criteria:

1. patients aged below 35 years or above 86 years;
2. patients who had a hemorrhagic stroke;
3. patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit;
4. patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions
5. patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics;

(7) patients with a severe stroke (NIH stroke scale \> 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs
A Prediction Model of Anastomotic Stricture After Rectal Cancer

Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.

Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.


Eligibility Criteria:
Inclusion Criteria:

1. pathological confirmation of rectal cancer;
2. eligibility for surgical intervention;
3. undergoing first rectal cancer surgery;
4. acquisition of written informed consent from patients and their families;
5. no history of hypertrophic scar or allergic predispositions.

Exclusion Criteria:

1. absence of postoperative follow-up or anastomosis details;
2. patients subjected to Hartmann or Miles procedures;
3. emergency surgery candidates due to conditions like perforation or obstruction;
4. diagnosis of multiple primary malignancies;
5. intraoperative discovery of widespread implant metastases within the abdominal cavity;
6. severe comorbidities;
7. anastomotic recurrence of rectal cancer;
8. patients who had undergone stapled hemorrhoidopexy