cyrilzakka/clinical-trials huggingface dataset:
Examining the Effects of Processed Music on Chronic Pain

Chronic pain is a common ailment in aging populations and often co-occurs with altered regulation of the autonomic nervous system. Nociceptive pathways (i.e., those that transmit pain signals) are integrated with autonomic circuits throughout the body and therapies that are successful in reducing pain concurrently alter autonomic functions, even when they are not directly designed to do so. It is possible that interventions that target the autonomic circuits that regulate pain responses may help reduce pain in chronic pain sufferers. The proposed study will examine whether an intervention that targets the autonomic nervous system via filtered music can reduce pain, a hypothesis derived from the Polyvagal Theory.

The Polyvagal Theory describes how function and structure of the vertebrate autonomic nervous system changed during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. An evolutionary "old" branch of this nerve innervates structures below the diaphragm and its dysfunction is linked to lower body organ and tissue pain. Regulation of the vagus nerve is linked with specific auditory cues based on our evolutionary heritage and the physics of the middle ear. This study is designed to test whether processed music designed to stimulate vagal function can decrease chronic pain. The Listening Project Protocol, the processed music used in this intervention, has previously been shown to effectively stimulate the function of the vagus nerve (see stimulus description below).

Specific Aims:

Aim I: To examine whether The Listening Project Protocol, a non-invasive audio intervention, can be effective for reducing chronic pain in a sample of older adults.

Hypothesis: Five 1-hour sessions of the Listening Project Protocol will reduce pain

Aim II: To examine whether increased regulation via the autonomic nervous system accounts for the decrease in pain if the intervention is successful.

Hypothesis: Pain reduction will coincide with improved autonomic function by the myelinated vagus nerve (measured by respiratory sinus arrhythmia, see below) as well as decrease in the reactivity of autonomic functions in everyday experiences (measured by the Body Perception Questionnaire, see below)


Eligibility Criteria:
Inclusion Criteria:

* Participants must self-report as suffering from chronic pain

Exclusion Criteria:

* Individuals who do not read or speak proficient English
* Individuals with substantial, uncorrected hearing loss
Neurolinguistic Programming on Labor Pain

THE EFFECT OF NEURO LINGUISTIC PROGRAMMING ON LABOUR PAIN, FEAR, DURATION AND MATERNAL SATISFACTION

In this study, it is aimed to determine the effect of neuro linguistic programming on labour pain, fear, duration and maternal satisfaction.

Sample size:

* The sample size of the study is 124 (for primiparous=62, multiparous=62).
* Frist, primiparous women who applied to the hospital for vaginal delivery will be divided into 2 arms as 31 experimental group and 31 control group.
* Second, multiparous women who applied to the hospital for vaginal delivery will be divided into 2 arms as 31 experimental group and 31 control group.

Data Collection Tools;

* Introductory Information Form,
* Visual Analog Scale for Pain,
* Wijma Birth Expectation/Experience Scale B version,
* Birth Satisfaction Scale

Application time:

* The neurolinguistic programming will be applied to the experimental group. NLP application will be done when the cervical opening is 4 cm, when the cervical opening is 5-6 cm, when the cervical opening is 7-8 cm.NLP application will be done three times in total. Each session will last 20 minutes
* No neurolinguistic programming will be applied to the control group.

Measurement time:

* Introductory Information Form will be completed by the woman when the cervical dilatation is 3-4 cm.
* VAS for pain will be measured before and immediately after the application when cervical dilatation is 4 cm; before and immediately after the application when cervical dilatation is 5-6 cm; before and immediately after the application when cervical dilatation is 7-8 cm; when cervical dilatation is 9-10 cm.
* Wijma Birth Expectation/Experience Scale B version and Birth Satisfaction Scale will be completed by the woman in the postnatal ward at approximately the second hour postpartum after the birth has taken place.
* The labour duration will be started for the mother who comes to the delivery room when the cervical opening is 4 cm and the total labour duration will be measured in minutes after the birth occurs.
* The control group will not be administered NLP only, but the measurements will be completed as in the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women who give birth vaginally,
* whose birth takes place in the delivery room unit,
* who are 19 years of age or older and 35 years of age or younger,
* who are born at 37 and above gestational weeks,
* who give singleton birth,
* who do not have chronic diseases and any complications in this pregnancy and postpartum period

Exclusion Criteria:

* mothers who wish to leave the study voluntarily at any stage after being included in the study,
* who develop any health problems in themselves or their babies during the birth and postnatal period will be excluded from the scope.
Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.

In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.

Subjects will undergo an electronic navigational bronchoscopy (ENB) during which three markers will be placed around their tumor which will guide the delivery of proton beam radiation to their with more precision and accuracy.

Subjects will receive a CT scan to obtain images to plan radiation treatment. Proton radiation will be delivered daily (4 or 5 consecutive days) on an outpatient basis at Massachusetts General Hospital.

After the final dose of proton radiation subjects will be followed for 5 years. Subjects will be asked to return at 3 months, and then every 3 months until 2 years, and then every 6 months until 5 years. Subjects will receive a chest CT, tumor assessment by CT or PET, chest x-ray, pulmonary function tests and a physical exam.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed)
* Stage clinical T1 N0 M0 or T2 N0 M0
* NSCLC must be limited to a single lesion
* NSCLC must be peripherally located (\> 2 cm from proximal bronchial tree and \> 1 cm from mediastinal pleura)
* NSCLC must be considered medically inoperable
* Life expectancy greater than 6 months

Exclusion Criteria:

* Pregnant or breastfeeding
* Prior radiation therapy to the lungs or mediastinum
* Prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated
* Receiving other study agents or other types of cancer therapy
* Uncontrolled intercurrent illness
* Pacemaker or defibrillator-dependent
Achieving Portal Access With Scorpion Post-Approval Study (APASS)

Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of the TIPS procedure
2. TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
3. Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization
4. Willing and able to comply with the study procedures and follow up schedule

Exclusion Criteria:

1. Known active malignancy
2. MELD score ≥ 18 at time of screening
3. History of polycystic liver disease
4. Active bleeding from any source
5. Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt
6. Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination
7. Active or uncontrolled hepatic encephalopathy
8. Systemic infection/sepsis
9. Biliary obstruction
10. Uncorrectable coagulopathy
11. Any diminutive or partially thrombosed right portal vein
12. Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)
13. Known sensitivity to contrast or serious contrast reaction such as anaphylaxis
14. Pregnant women or women who are planning to become pregnant
Medico-legal Assessment of Sexual Violence-Assiut University

* Medico legal assessment of sexual assaults allegations of females presented to hospital and any associated violence.
* Assessment of cases of pregnancy associated violence with other related complications that have both medical and legal implications.
* Knowing role of VAW Unit in compacting female abuse offering support and authentication of suspicious claims

The data will be obtained after informed consents from cases. These cases will be then analyzed in terms of:

* Verifying legal procedures as careful reviewing of public prosecution order and associated victim's identification documents if present
* Obtain a detailed history including personal information as age, marital status' residence and education; incident circumstances like assault characteristics as numbers of assailants, relationship to the victim' place of assault' frequency of assault and the time lapse between examination and last assault, etc ; gynecologic and obstetric history.
* General examination that include proper documentation of all visible injuries all over the body (type' direction' location' shape) and local examination of genital or anal region and possibility of taking vaginal and anal swabs if possible.
* Re-examined victim after two weeks for exclude any venereal diseases and doing pregnancy test.

Eligibility Criteria:
Inclusion Criteria:

* All females above ≥ 12 years old with suspicious sexual violence or illegal pregnancy or criminal induction of abortion.

Exclusion Criteria:

* All females who will present to the women's health hospital above 12 years old for ordinary medical advice or treatment of gynecologic or obstetric complaints
The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
2. Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
3. The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
4. No bulky lymph node metastasis is detected by abdominal CT.
5. No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
6. No clinically apparent distant metastasis.
7. Karnofsky performance status ≥70%.
8. Sufficient oral intake.
9. No previous treatment with chemotherapy or radiation therapy for any tumors.
10. No previous surgery for the present disease.
11. Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0\*104/mm3 (5.0\*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
12. No need for emergency surgery due to bleeding or perforation of the primary tumor.
13. No mechanical obstruction.
14. Written informed consent.

Exclusion Criteria:

1. Past history of upper abdominal surgery.
2. Past history of surgery for the gastrointestinal tract.
3. Body mass index exceeding 30 kg/m2.
SAT vs Escitalopram for Rectal Hypersensitivity

Constipation is a common digestive disorder. After excluding dietary factors, drugs and other secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit constipation (STC), all predominantly affect women and elderly. Many patients also demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity being common. Recent surveys show that most constipated patients are dissatisfied with current therapy. Also, constipated patients showed significant psychological dysfunction and impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of improving rectal hypersensitivity.

METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8 patients with rectal hypersensitivity (urgency/pain threshold \<30 mm Hg). Sensory deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal thresholds were reached.

To investigate a novel biofeedback technique of improving rectal hypersensitivity using rectal barostat and to compare this with clinical standard of care comprising of low dose antidepressant therapy with escitalopram. Patients will be randomized to sensory adaptation training or escitalopram in a 1:1 ratio

Eligibility Criteria:
Inclusion Criteria:

All patients must fulfill the diagnostic criteria for IBS-C (Rome III) as defined below and have rectal hypersensitivity (see below).

* Patients must report recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months with two or more of the following symptoms:

  * Improvement with defecation; and/or
  * Onset associated with a change in frequency of stool; and/or
  * Onset associated with a change in form (appearance) of stool
* No structural diseases
* On a diary:

  * Pain/discomfort for at least 2 days/week;
  * No loose or watery stool \<25% of bowel movements.

Exclusion Criteria:

* Patients with mixed-IBS.
* Patients currently on SSRI or MAO inhibitors. Patients on stable doses of other antidepressants will be included provided the dose is unchanged during study.
* Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued)
* Patients with co-morbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
* Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries.
* Impaired cognizance (mini mental score of \< 15) and/or legally blind.
* Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures.
* Hirschsprung's disease.
* Alternating constipation and diarrhea (22).
* Ulcerative/Crohns colitis.
* Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery.
* Rectal prolapse or anal fissure.
Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL

Virological failure is a complication of treatment in patients with HIV, and it can be as high as 42% to first line treatment or around 18% in second line treatment. The reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). People living with HIV needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. For that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. Among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of RNA virus. Then, we propose an open label clinical trial to evaluate the effect of isoprinosine in HIV patients with a virological load between 50 and 200 copies/ml.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old.
* Patients with a viral load (RNA of VIH) between \> 50 and \< 200 copies/mL after 24 weeks of antiviral therapy or after scheme change.
* Informed consent signature

Exclusion Criteria:

* Younger than 18 years old.
* No virologic failure or RNA of VIH \> 200 copies/mL.
* Presence of a serious opportunistic infection.
* Renal failure (including litiasis) or presence of gout.
* Pregnancy.
Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients

This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a wifi connexion at home
* Patient with the ability to modulate the height of the candle by thinking in the alpha synchrony test.
* Patient with chronic low back pain for more than six months with a visual analogue pain scale greater than 5 impacting activities of daily living, hobbies and work
* Patient having given free and informed consent and signed consent.
* Affected patient or beneficiary of a health insurance plan.
* Patient who is at least 18 years old (≥) and younger than 75 years old (\<).

Exclusion Criteria:

* Pregnant or breastfeeding patient
* Patient with a contraindication to performing a fMRI scan: ferromagnetic implant in the body, piercing, claustrophobia, unable to remain in the scanner stationary for 40 minutes
* Patient already included in another study
* Patient in a exclusion period determined by a previous study
* The subject is under the protection of justice, guardianship or curatorship.
* The subject refuses to sign the consent.
* It is not possible to give the subject informed information.
Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

The investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the Visual analogue scale(VAS), neck disability index scale (NDI) and short form 36-item questionnaire (SF-36).

Based on the digital acupuncture manipulation therapeutic instrument developed in the previous stage, the acupuncture manipulation acquisition system is used to compare and analyze the analog waves output by the experts' acupuncture manipulation and the manipulative therapeutic apparatus in the system data analysis module, in order to verify the consistency of bioelectric signals of different reinforcing and reducing manipulation of acupuncture and experts' manipulation. The biocompatibility of shock wave was detected by Massachusetts General Hospital Needle sensation scale ((Massachusetts General Hospital Acupuncture Sensation Scale, MASS)). The visual analogue pain score ((Visual analogue scale, VAS)), neck disability index scale ((Neck Disability Index,NDI) and short form 36-item questionnaire (SF-36) were used to evaluate the clinical efficacy and safety of the instrument in the treatment of cervical pain in cervical Spondylotic radiculopathy, and the appropriate syndrome type of the scheme was studied.

Eligibility Criteria:
Inclusion Criteria:

1. Neck pain with the diagnosis of cervical spondylotic radiculopathy;
2. Aged between 18-70 years;
3. Have not participated in any drug clinical trials within the last month;
4. Voluntarily joining this study with informed consents

Exclusion Criteria:

1. A history of cervical spine trauma or have received cervical spine surgery;
2. Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;
3. Cervical spondylosis in urgent need of surgery;
4. Pregnant women and lactating women;
5. A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
6. Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks
Treating Hypertension With Breath Control

The purpose of this study is to determine if blood pressure can be reduced in hypertensive subjects by regularising and slowing their breathing. This may be a safe and affordable complementary treatment for hypertension.

This is a randomised controlled trial in which hypertensive subjects allocated to receive either a CD with relaxation music or one with the same music plus certain sound cues to guide the listener on when to breathe. The subjects will continue with their normal medications and the intervention will last 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Patients with essential hypertension
* Systolic BP from 140 to 159 mm Hg
* Diastolic BP from 90 to 99 mm Hg
* On hypertensive medication for at least 3 months before the study
* Hypertensive medication unchanged during the 3 months before the study
* Patients able to fill in a log sheet

Exclusion Criteria:

* ischaemic heart disease
* congestive heart failure
* cardiac arrhythmias
* renal failure
* diabetes mellitus
* previous stroke
* major organ failure
* cigarette smoking
* respiratory diseases
* psychiatric disorders
* severe obesity (BMI \>35 kg/m2)
* hearing impairment
* unable to operate a CD player or do not have access to a CD player
* arm circumference \<22 cm. or \>42 cm.