cyrilzakka/clinical-trials huggingface dataset:
Pain Phenotypes in Chronic Pancreatitis

Chronic pancreatitis (CP) is characterised by recurrent abdominal pain. The pathological hallmarks of CP is pancreatic stellate cell activation that results in persistent inflammation and progressive fibrosis. It has been shown in various clinical and experimental studies that with disease progression there could be pancreatic neural inflammation, spinal sensitization and eventually alteration in the pain modulating architecture within the brain (widespread sensitization). These events result in different types of pain (nociceptive and neuropathic) in patients with CP, which may dynamically change during disease progression.

Since the treatment for different mechanisms are unique, it becomes important to identify the predominant type of pain. Recently, pancreatic quantitative sensory testing (P-QST) has emerged as a valuable tool to identify different types of sensitization. This facility is currently available only in select centers and is being conducted under research protocols.

In this study, we propose to: 1. evaluate the patterns of pain in CP and the triggers; 2. identify clinical surrogates of sensitization, i.e. neuropathic pain.

The ultimate goal is to apply the best possible pain management strategy based on our research findings for patients with CP in a personalised manner.


Eligibility Criteria:
Inclusion Criteria:

* At least 3 years of disease (chronic pancreatitis)
* Both genders
* Able to provide informed consent

Exclusion Criteria:

* Acute exacerbation of chronic pancreatitis
* Moderate to severe abdominal pain at the time of screening
* Pancreatic cancer or other malignancies
* Use of antidepressants, narcotics, and neuromodulators
Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12.

Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life.

Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Advanced, metastatic, or recurrent head and neck cancers
* Poor risk patients with ECOG performance status of 2

Exclusion Criteria:

* Prior treatment for recurrent or metastatic disease
* No clinical or radiological evidence of brain metatases
* Patients with bone only disease are not eligible
* Patients with pleural or peritoneal effusion as only manifestation of diesase
Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

Tramadol for labor analgesia: a low risk placebo controlled randomised control trial

Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular route in a blinded manner. Visual analogue score will be assessed in the beginning and every hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end

Eligibility Criteria:
Inclusion Criteria:

* delivering for first time(nulliparous)
* well established labor ( 3 or more contractions in a span of ten minutes
* cervical dilation of 4 cm or more
* \>= 80% effacement of cervix

Exclusion Criteria:

* any medical disorder- diabetes,hypertension
* obstetric high risk factors
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study

Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

The mobile phone app Sweetch seeks to increase leisure time physical activity rather than formal exercise through the use of a behavioral analytics engine that continuously process various aspects of the user's life habits, taking into account the user's demographics, behavioral change status, schedule, actual activity patterns, and more. The rationale behind this approach is that long-term adherence and patient engagement are more likely to be achieved when demands on manual user data entry are kept at a minimum. Compared to similar smartphone-assisted prevention apps, there are two novel features of the Sweetch app that may increase its efficacy. First, it uses a "just-in-time" adaptive intervention" approach that tailors recommendations to the user's day-to-day routine and his or her readiness for behavioral change. Second, and most importantly, it requires no direct involvement by the user, since all the necessary data is collected using built-in tracking pedometers, accelerometer and Global Positioning System (GPS) sensors on smartphones. In contrast, interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient content), require active user tracking at every meal, which is difficult to maintain in the long-term even with the use of sophisticated, electronic calorie counting tools. For these reasons, the Sweetch app may achieve greater long-term adherence, which is usually a limiting factor to efficacy of mobile health interventions.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 -75 years with prediabetes (fasting Blood Glucose (BG) 100-125 mg/dl, A1C 5.7% - 6.4%, or 2 hour BG of 140-199 mg/dl following 75-gram oral glucose tolerance test)
* Body mass index 24 - 40 kg/m2
* English speaker
* Smartphone user (Android or Apple 5s and above)

Exclusion Criteria:

* Currently doing more than 150 minutes/week of moderate/vigorous physical activity
* Presence of medical conditions that prevent adoption of moderate physical activity
* Use of any glucose-lowering or weight loss medications within the previous 3 months
* Current pregnancy (self-reported) or planning pregnancy during study period (self-reported)
* Presence of any condition that can result in spurious A1C readings (e.g. anemia \[hemoglobin level below lower limit of normal\] secondary to iron, vitamin B12, or folate deficiencies; hemoglobinopathies)
* Use of systemic glucocorticoids
* Use of antipsychotic medications (stable doses for at least three months of anti-depressants or anti-anxiety drugs will be allowed)
* Severe mental illness or learning disability
* Current participation in another clinical trial
* Liver enzymes \>3 x upper limit of normal
* Poor literacy (REALM-R score of 6 or less)
Safe Babies: Parenting Action Plan ( PAP )

The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.

The purpose of this project is to evaluate whether prevention education using motivational interviewing focused on promoting positive maternal mental health, coping with inconsolable crying, life stress reduction, and positive coping strategies with difficult infant behavior can provide complimentary messaging that supports positive parental behavior and reduces risks associated with poor mental health and infant maltreatment. The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. It is delivered using motivational interviewing techniques. This study is not designed to develop education for "at-risk" individuals, rather the purpose is to develop a populationlevel prevention program.

Eligibility Criteria:
Inclusion Criteria:

* maternal caregivers of infant 2 months and younger
* can read and speak English or Spanish
* has zoom / teams / facetime / google hangout capability

Exclusion Criteria:

* infant is older than 2 months of age
* under 18 years of age
* no video/virtual capability
Effects of TENS Therapy Following Arthroscopic Knee Surgery

Following standard of care procedures for arthroscopy knee surgery it is anticipated that Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and improve functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* BMI\<50
* No significant joint malalignment
* No significant ligamentous instability
* No significant radiographic joint space narrowing
* No prior significant knee surgery
* Unilateral knee surgery
* Not workman's compensation
* Planned knee arthroscopy for meniscectomy, chondroplasty or synovectomy

Exclusion Criteria:

* Age \<18 or \>60
* BMI \> 50
* Significant joint malalignment
* Significant ligamentous instability
* Significant radiographic joint space narrowing
* Prior significant knee surgery
* Bilateral knee surgery planned
* Worker's Compensation
* No planned knee arthroscopy for menisectomy, chondroplasty or synovectomy
Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia

The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement


Eligibility Criteria:
Inclusion Criteria:

* confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)
* severe pneumonia with baseline chest X-ray abnormalities;
* Oxygen saturation \<94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
* Informed consent signed.

Exclusion Criteria:

* Not willing to participate in the study.
Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment

The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.

Obstructive sleep apnea syndrome (OSAS) remains poorly documented in head and neck cancer cancer population, who have a higher risk than the general population. OSAS is a risk factor for quality of life impairment and cardiovascular morbidity and mortality.

This study proposes to carry out an OSAS prevalence study among a locally advanced head and neck cancer population, already treated and to compare the consequences of current therapeutic options in sleep quality.The primary research objective will be a prevalence determination in a locally advanced stages treated population of oropharyngeal cancer. Secondary objectives will be the comparison of the prevalence between the surgical group and the radio-chemotherapy group, the research of predictive factors of presenting an OSAS and the precision of the impact on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years old, male or female;
* Patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated T3 or T4, whatever the stage N and M0;
* Patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy;
* Treatment completed at least 12 months prior to study entry;
* Patient whose cancer disease is under control at exam time;
* Subject affiliated to a social security scheme;
* Subject agreeing to participate in the study and who signed the informed consent form.

Exclusion Criteria:

* Minor patient
* No affiliation to a social security scheme (beneficiary or assignee);
* Patient who did not signed the informed consent form
* Patient with neurological disease that can affect the upper airways function
* Patient has already been treated for head and neck cancer;
* Patient has a lesion classified T1 or T2 or M1;
* Patient has received different treatments: surgical resection without reconstruction, only radiotherapy
* Unweaned alcoholic patients
Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries

Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries

The interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.The utility of the superior trunk block has yet to be studied in shoulder surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
* Both genders.
* Aged group from 21 to 50 years old.
* Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.

Exclusion Criteria:

* Refusal of the procedure or participation in the study.
* Any history or evidence of coagulopathy.
* Evidence of infection at injection site.
* Allergy to study drugs.
* Patients with pulmonary severe respiratory disease.
* Herniated cervical disc or cervical myelopathy.
* Pre-existing neuropathy of the operative limb
Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)

A two-phase research study is being conducted. In Phase 1 of the study, the cognitive behavioral therapy intervention for insomnia was implemented in a small (n = 5) group of people with moderate to severe COPD and insomnia. The intervention was pilot-tested to determine feasibility and acceptability, and the intervention will be refined as needed. In Phase 2 of the study, a two-group randomized controlled study (n = 20) will be conducted to test the effects of the cognitive behavioral therapy for insomnia intervention on the primary outcomes of sleep quality and fatigue and the secondary outcomes of mood and functional performance. It is hypothesized that people with COPD receiving cognitive behavioral therapy for insomnia will demonstrate significant improvements in sleep quality, fatigue, mood and functional performance as compared to people with COPD who receive a wellness program. This research will yield valuable information regarding effective interventions aimed at mitigating problems such as poor sleep quality, fatigue and reduced ability to perform valued daily activities. This information will be used to increase the likelihood of long-term successful outcomes such as the ability to maintain productive roles in society for people with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will have moderate to severe COPD. Severity of COPD will be defined according to the new GOLD standards (moderate IIA (moderate), 50% \< FEV1 \< 80% predicted; moderate IIB (severe) 30% \< FEV1 \< 50%). 58
* Insomnia. Insomnia will be defined as difficulty initiating or maintaining sleep, waking up too early or poor quality sleep. 59
* Subjects must be \> 45 years of age with no other major health problems
* Subjects must be clinically stable at the time of enrollment into the study without major exacerbation of COPD within the previous two months.

Exclusion Criteria:

* Evidence of restrictive lung disease or asthma.
* Evidence of a major sleep disorder other than insomnia (sleep apnea evidenced by apnea/hypopnea index of \> 10, periodic limb movement disorder, narcolepsy).
* Hypnotic, sedative, anxiolytic or antidepressant use.
* Pulse oximetry (SaO2) reading of \< 90% at rest.
* Pulse oximetry (SaO2) reading of \< 85% at night for \> 5 minutes.
* Significant sleep apnea (apnea/hypopnea index ≥ 10).
* .Acute respiratory infection within the previous 2 months.
* Class \> 2 functional status according to the New York Heart Association.
* The presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
* A self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of \> 11.
* Currently participating in pulmonary rehabilitation.
Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Chronic heart failure is becoming more and more common disease and activation of sympathetic nervous system plays a crucial role in its development. There is some data allowing to suspect that one of the new treatment methods- renal denervation, also in patients with chronic heart failure may lead to decrease of systemic activity sympathetic nervous system and, as a consequence, to decrease of disease progression. The research hypothesis is whether renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is used (including resynchronization therapy), is contributing to the improvement in parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far only very limited data- mostly case reports- are available in this study area.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 year
2. heart failure patients NYHA Class II - IV
3. implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
4. symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
5. left ventricular ejection function ≤ 35%
6. glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
7. patient informed consent for participation in the study

Exclusion Criteria:

1. renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
2. history of prior renal artery intervention
3. single functioning kidney
4. clinic systolic BP \< 110mmHg
5. pregnancy
6. acute coronary syndrome or cerebrovascular event within last 3 months
7. serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)
Effects of Proportioning Meat and Plant-based Protein-rich Foods on Cardiovascular Disease Risk Factors (S58)

This project will assess the effects of consuming different proportions of red meat (RM) and plant-based, protein-rich foods (nuts, seeds, and soy products - NSS) incorporated into a U.S. Healthy Eating Pattern (HEP) on cardiovascular disease risk factors in adults at high risk of developing a heart-related disease.

Using a randomized, cross-over (balanced incomplete block) experimental design, Forty-eight middle-aged adults who are overweight and have high blood total cholesterol and LDL-C concentrations will be recruited. Participants will consume a HEP - all foods provided - during 5-week controlled feeding periods. The three HEP interventions will be: high RM, low NSS; moderate RM, moderate NSS; and low RM, high NSS. Each participant will complete two of the three controlled feeding periods, separated by four weeks when participants will consume their usual unrestricted diet (washout). The HEP consumed during the controlled feeding periods will be the same except for the amounts of RM (1, 5, or 9, 3-oz servings/wk) and NSS (high, moderate, and low, with amounts adjusted to isocalorically offset changes in RM energy intakes). Poultry, egg, and legume intakes will be the same among the three HEP. The investigators will measure clinically important cardiovascular disease risk factors before (usual unrestricted diet) and during the last week of each HEP intervention. The cardiovascular disease risk factors will include, but are not limited to, comprehensive lipid and lipoprotein profile (changes in low-density lipoprotein cholesterol, LDL-C; primary outcome), lipoprotein fractionation and particle numbers, and blood pressure. The investigators will compare improvements in heart disease risk factors and consumer satisfaction among the three HEP.

Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* Age 30-69 y;
* BMI: 25.0-37 kg/m2;
* Have hypercholesterolemia (total and LDL cholesterol 200-259 and 130-189 mg/dL, respectively),
* Systolic/diastolic blood pressure \<140/90 mm Hg;
* Triglycerides \<399 mg/dL, fasting glucose \<109 mg/dL
* Body weight stable for 3 months prior (±3 kg);
* Stable physical activity regimen 3 months prior;
* Medication use stable for 6 months prior;
* Non-smoking;
* Non-diabetic;
* Not acutely ill;
* Females not pregnant or lactating;
* Participants must be willing and able to consume the prescribed diets and travel to testing facilities.

Exclusion Criteria:

* BMI \<25 or \>37
* Total cholesterol \>259 mg/dL, low-density lipoprotein cholesterol \>189 mg/dL,
* Triglycerides \>400 mg/dL, fasting glucose \>110 mg/dL
* Body weight changes in previous 3 months (±3 kg)
* Changes in physical activity regimen in the previous 3 months
* Medication changes in the previous 6 months
* Smoking
* Diabetic
* Acute illness
* Pregnant or lactating
Understanding Patient Engagement Trends in Anxiety Disorder Clinical Research

Clinical trials, specifically focused on anxiety disorder, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosis of anxiety disorder
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Female patients who are currently pregnant or nursing
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Inability to perform regular electronic reporting