cyrilzakka/clinical-trials huggingface dataset:
The Immune Function Intervention Trial

The purpose of the study is to examine whether cardiovascular exercise training improves immune responses to vaccination in previously sedentary older adults.

The extent to which exercise training or long-term physical activity influences poorly regulated immune function in the elderly is unclear. Preliminary evidence suggests that exercise training may improve various immune function measures in older adults. Although such findings have the potential to be of substantial public health importance, the majority of studies have suffered from small sample sizes, inadequate measurement of physical fitness, and weak research designs.

This study is designed to overcome these limitations by employing a longitudinal randomized controlled trial examining the effect of exercise training on clinically relevant immune function measures in older adults (65-80 years). Moreover, relationships between several factors known to be altered by exercise training and changes in immune function will be assessed. As such, there are two specific aims to be addressed. In Aim 1, a 10-month exercise trial will determine whether moderate intensity aerobic exercise training can improve immune function in previously sedentary older adults. In Aim 2, the role played by physiological, behavioral, and psychosocial factors in the relationship between exercise training and improved immune function will be examined.

150 sedentary participants will be randomly assigned to either a 10-month moderate aerobic exercise training program or a sedentary control group. Clinically relevant measures of immune function including the delayed-type hypersensitivity (DTH) response to a battery of antigens and the antibody response to tetanus toxoid and influenza virus vaccination will be assessed before, during and after the intervention. We hypothesize that exercise training will result in improved immune responses including higher peak antibody titers and DTH responses, and sustained levels of protective antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Ages 62-82
* Ability to participate in an exercise program
* Medical clearance by primary physician
* Non-smoker
* BMI 22-38
* Independently living
* Post-menopausal
* Sedentary for over 6 months

Exclusion Criteria:

* No recent history (within 6 months) of infection or vaccination
* History of systemic reactions to vaccination
* History of cancer
* Severe allergies/asthma requiring prescription medication
* Splenectomy or transplant patient
* Chronic Obstructive Pulmonary Disease (COPD)
* HIV positive
* Uncontrolled diabetes or hypertension
* Severe arthritis
* Mental illness or clinical depression
* Impaired cognitive status
Relationship of Obesity With GERD Among Nigerians

Obesity is a strong risk factor for GERD. This study assessed the role of obesity among patients having erosive GERD and controls.

A case control study of patients with erosive GERD. Patients with erosive GERD who had upper gastro-intestinal endoscopy were graded using the Los Angeles classification. Patients and controls had measurements of body mass index (BMI), WC (waist circumference), Waist hip ratio (WHR), and hip circumference (HC). Bio-data was collected from both groups and data were analysed using descriptive and inferential statistics. A p value of equal to or less than 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients with dyspepsia

Exclusion Criteria:

* Patients that refused consent.
* Patients with gastric cancer
* Patients with gastric outlet obstruction
* Pregnant women
* Active gastrointestinal bleeding
* Cigarette smokers
* Patients on Naso-gastric tube.
Intraoral Injection of Trigger Points by Botox

Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1 week, 4, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).


Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of myofascial pain with a referral
* the presence of one or more trigger points in the unilateral or bilateral masseter muscle -
* no history of any invasive procedures in the related masseter muscle

Exclusion Criteria:

* Factors that can cause pain in the orofacial region other than trigger points (decayed tooth, temporomandibular joint internal disorder).
* Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
* pregnancy and lactation.
Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery

To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery.

Hamilton anxiety Scale was used to screen patients with anxiety. Only patients with score ≥ 8 were enrolled. These patients were randomly assigned to the experimental group and control group.

All patients enrolled were evaluated with Hamilton anxiety Scale, PHQ-8 scale, QoR-15 Scale and Athens Insomnia Scale. After induction, sevoflurane and remifentanil were used to maintain anesthesia. The experimental group had esketamine while the control group had normal saline. Athens Insomnia Scale was used to assess the sleep status 1, 2, 3 days after surgery and 1 month after surgery. Hamilton anxiety Scale was used to evaluate the anxiety state of the patients 3 days after surgery and 1 month after surgery. PHQ-8 scale, QoR-15 Scale were collected 3 days after surgery and 1 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing abdominal tumor surgery;
* older than 18 years old and younger than 70 years old;
* ASA grade I-III；
* Hamilton anxiety scale ≥ 8.

Exclusion Criteria:

* Having serious mental illness before surgery or on antipsychotic medication in the two weeks before screening;
* Severe organ function lesions such as heart failure (left ventricular ejection fraction \<30%), myocardial infarction, kidney failure (requiring kidney replacement therapy), liver function impairment (Child-Pugh grade C), etc.
* Patients arranged to receive general anesthesia combined with epidural anesthesia patients;
* Patients who cannot communicate, read or write due to visual, auditory, language or other reasons;
* Patients allergic to ketamine;
* Patients refused to use postoperative self-controlled intravenous analgesia pump;
* Patients refused to participate in the study.
Logan Basic Technique Measured by Surface Electromyography (EMG)

The purpose of this investigation is to determine the effect of Logan Basic Technique apex contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via surface EMG.

LBT is a low force adjusting technique that focuses on the foundation segment of the spine, the sacrum, with application of contact on the sacrotuberous ligament which relieves fatigued and strained muscles, particularly intrinsic muscles of the back. Surface electromyography (EMG) is a method of analyzing the activity level of superficial muscles. It is convenient and advantageous when studying muscle relaxation which occurs in biofeedback studies

Eligibility Criteria:
Inclusion Criteria:

* Students in trimesters 1 - 3.
* Naive to the Logan Basic Technique adjusting protocol.

Exclusion Criteria:

* Students in trimesters 4 - 10.
* Pregnant females or females who can possibly be pregnant.
Genetic Study of Familial Epilepsy

OBJECTIVES:

I. Determine the chromosomal regions that contain genes that raise the risk of epilepsy in families by performing genetic linkage analysis of idiopathic/cryptogenic epilepsy.

PROTOCOL OUTLINE: Family histories are obtained, then the patients undergo an interview, a neurological examination, and EEG. Blood specimens are also collected.

Linkage analysis is performed on specimens and analysis of shared marker alleles are used to identify genomic regions likely or unlikely to contain the epilepsy genes. Genotypes in family members are determined at microsatellite markers throughout the genome. Markers tested include chromosomes linked to human epilepsy syndromes (6p, 8p, 8q, 20q, 21q) and chromosome 3 (similar to mouse "epilepsy" genes). Linkage to markers on chromosome 10q are also tested.

Patients do not receive the results of the testing and the results do not influence the type and duration of any treatment.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Male or female members of families with at least 1 close relative pair (sibling, half sibling, avuncular, grandparent-grandchild, or first cousin) affected with idiopathic/cryptogenic epilepsy that developed before age 25
KIOS Mobile App Evaluation

Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).

The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS will offer individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients 18 years of age or older
2. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
3. DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder
4. Ability to access KIOS via smartphone or tablet
5. Recently (less than 6 months) enrolled in and currently participating in MOUD at a clinic in Texas

Exclusion Criteria:

1. Unwilling or unable to comply with study requirements
2. Psychiatric or medical disorder interfering with ability to use the app
3. Incarceration
Ankle Brachial Index Combined With Serum Uric Acid Levels Improve Prediction All Cause Mortality and Cardiovascular Mortality in the Elderly Chinese Population

Peripheral arterial disease (PAD) is a common clinical manifestation of the systemic atherosclerotic process, and the ankle brachial index (ABI) is an ideal tool to diagnose PAD. The association between high serum uric acid levels (SUA) and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. It has also been confirmed by clinical studies. Currently, there have been few long term follow up studies focused on the whether serum uric acid levels combined with ankle brachial index can improve prediction all cause mortality and cardiovascular mortality,especially in China population.Therefore, the aim of this study was to elucidate whether ABIcombined with SUA can improve prediction all cause mortality and cardiovascular mortality in the elderly China population independently of the traditional Framingham Risk Score.

This study is a prospective community-based cohort study, which is aimed to investigate the prognostic factors, including conventional cardiovascular risk factors and measure ABI,SUA,asymptomatic target organ damage, for mortality and cardiovascular diseases. All population were separated into ABI ≤0.50，0.51 \<ABI ≤0.9，and 0.91 \<ABI≤1.40 three groups according to the ABI. ABI ≤0.9 was selected as cut point for the definition of PAD. Factors related to CVD and all-cause mortality, major adverse cardiac events (MACE) during follow-up was observed by multivariate Cox regression analysis and log rank test. Potential confounding variables with P \<0.10 were adjusted for multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

1. age≥65 years old
2. Shanghai residents
3. Sign informed consent

Exclusion Criteria:

1. serious heart disease (NYHA\>IV) or end stage renal disease (CKD \> 4)
2. cancer and life expectancy was less than 5 years
3. Severe congestive heart failure and Severe renal failure patients
4. Participants had other diseases that required withdrawal from the clinical trial
5. Patients are reluctant to participate in clinical research
6. The patient violated the experimental protocol
7. Clinical diagnosis of Alzheimer's Disease
To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure

This study is a multi-site, unmasked phase IV study. Travacom(R) is a combination topical ocular agent, containing travoprost and timolol, which lower intraocular pressure (IOP) by complementary mechanisms of action. The safety and efficacy of both travoprost and timolol have been established as single and adjunctive therapy in well-controlled clinical studies in thousands of patients diagnosed with open angle glaucoma (OAG) or ocular hypertension. The objective of this study is to assess the safety and efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension across India.


Eligibility Criteria:
Inclusion Criteria:

* Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Must be able to follow instructions and be willing and able to attend all study visits.

Exclusion Criteria:

* A known medical history of allergy, hypersensitivity or poor tolerance to any component of Travacom that is deemed clinically significant in the opinion of the Principle Investigator.
* Any abnormality preventing reliable applanation tonometer in either eye. Corneal dystrophies.
* Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?

The purpose of this study is to study port symmetry and the incidence of anterior abdominal wall neuropathy associated with gynaecological surgery.

We plan to study patients undergoing gynaecological laparoscopy. Patients will be randomized to two techniques for determining where to position the right and left lateral laparoscopic ports, and port symmetry will be assessed at the end of surgery. We also plan to study patients undergoing any type of gynaecological surgery to determine the incidence of sensory neuropathy involving the lower abdomen according to the route of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria:

* Previous laparoscopy
* Junior intern as primary surgeon
Umbilical Pilonidal Sinus: a Case Report

Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene; however, it can be seen in females. UPS could easily be misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. Diagnosis is easy to establish with physical examination and a detailed history. Treatment is generally depending on the severity of the disease, ranging from good personal hygiene to surgical excision of umbilical complex. The treatment of choice for chronic, intermittent cases is surgical removal of the affected portion; paying special attention to cosmetic appearance especially in female patients. In this report, we present two cases of UPS, one in a man and one in a woman with the explanation of its etiopathogenesis and surgical treatment.

Introduction: Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene. It is being diagnosed and reported more frequently; however, there is still no consensus regarding its best treatment options.

Presentation of cases: In this report, we present two cases of UPS, one in a man and one in a woman who had typical symptoms with pain, swelling and intermittent malodorous discharge from the umbilicus. They had small sinus openings with hair protruding deep in the navel. Because patients had previous history of failed conservative treatments an umbilicus preserving surgery was performed for both cases.

Eligibility Criteria:
Inclusion Criteria:

* no limitation

Exclusion Criteria:

* patients followed-up less than 2 years
Annual Study to Investigate Inactivated Virosomal Influenza Vaccine for the 2006/2007 Influenza Season in Europe.

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available virosomal vaccine (Invivac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza virosomal vaccine in two groups of healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent.
* Healthy and aged \>= 18 and \<= 60 years or \>= 61 years of age.
* Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire."

Exclusion Criteria:

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
* Having experienced a documented serious systemic reaction after previous influenza vaccination.
* Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
* Having received vaccination against influenza within the previous six months before Visit 1.

Exclusion criteria only for female subjects aged \>=18 and \<=60 years and of childbearing potential:

* Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
* Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown

Postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing aid associated skin breakdown better than standard care of bacitracin ointment alone in adult patients.

This is a prospective study. Multiple surgeons will perform the bone anchored hearing aids (BAHI) implantation surgery. Patients will be randomized to either postoperative medicinal honey or postoperative standard care of bacitracin ointment alone using a random number generator. There will be a total of two patient groups. The type of BAHI device used, laterally and the surgical technique will be recorded.

Treatment groups:

Group 1-patients undergoing BAHI implantation who will be postoperatively treated with medicinal honey.

Group 2- patients undergoing BAHI implantation who will be postoperatively treated with bacitracin ointment as standard care.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing bone-anchored hearing aid implantation surgery.

Exclusion Criteria:

* patients who are undergoing revision bone-anchored hearing surgery, history of radiation to the implantation site.
Efficacy and Safety of BG00012 in MS

Determine the efficacy, safety, and tolerability of BG00012 in MS patients.

The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 to 55 years old, inclusive, at the time of informed consent.
2. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
3. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
4. Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.
5. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.

Exclusion Criteria:

1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 \[Appendix 3\]).
2. History of malignancy.
3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
4. History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease.
5. History of human immunodeficiency virus (HIV).
6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
8. Body weight \>100 kg.
9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
10. Any of the following abnormal blood tests at screening.
11. Any previous treatment with FUMADERM®, FAG-201, or BG00012.
12. A medication history that precludes entry into the study.
13. Female subjects who are currently pregnant or breast-feeding.
Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18
* Younger than 75
* ECOG performance status 0 or 1
* Histologically confirmed adenocarcinoma of the pancreas
* Metastatic pancreatic cancer
* No prior chemotherapy for metastatic pancreatic cancer
* A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)

Exclusion Criteria:

* A patient with no measurable disease
* A patient who received previous palliative chemotherapy for pancreatic cancer
* A patient with locally advanced pancreatic cancer
* A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
* A patient with previous active or passive immunotherapy
* A pregnant or lactating patient