cyrilzakka/clinical-trials huggingface dataset:
Integrative Migraine Pain Alleviation Through Chiropractic Therapy

This pilot study evaluates the addition of chiropractic treatment to conventional neurological care in the treatment of migraine headaches in adult women. Half of the participants will receive 10 chiropractic treatments in addition to their usual care over a 14 week period, while the other half will continue their usual medical care alone, as prescribed by their physician during that time period.

Chiropractic care is a commonly used therapeutic intervention for the treatment of pain disorders, and some smaller studies have shown that it might be helpful for migraines. This pilot study will use a comprehensive model of chiropractic treatment which can include soft tissue mobilization, spinal manipulation, and postural and spinal stabilization and correctional exercises.

Specific Aims:

Aim #1 - Determine the feasibility of conducting a randomized control trial (RCT) of chiropractic care in adult women with migraine.

Aim #2 - To provide preliminary data on the safety and effectiveness of chiropractic care on migraine frequency, severity, duration, and medication use in adult women with migraine.

Aim #3 - To provide preliminary estimates of the effects of chiropractic on disability, health-related quality of life, and psychosocial well-being.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of episodic migraine with or without aura (International Classification of Headache Disorders-II)
* 4 to 13 days with migraines/month
* More than one year of migraines
* Agreeable to participate, commit to all study procedures, and to be randomized to either group
* Fluent in English (required to complete self-report instruments)

Exclusion Criteria:

* Currently, or having received chiropractic care in past 3 months for any condition
* Any major systemic illness or unstable medical or psychiatric condition (e.g. Parkinson's disease, cancer) requiring immediate treatment or that could lead to difficulty complying with the protocol
* History of stroke, carotid artery dissection, or vertebral artery dissection
* Head or neck trauma within the past year
* Diagnosis of medication overuse headache (International Classification of Headache Disorders-II)
* Began use of new prophylactic medication for migraine headaches within the last 3 months
* Currently taking prophylactic migraine medications other than propranolol and topiramate
* Failure to complete baseline diary recordings of migraine activity and medication use during run-in phase
* Currently, or having received Botox treatment for migraine
* Current alcohol or substance abuse (self-reported)
* Diagnosis of Ehlers-Danlos Syndrome
Intrauterine G-CSF Administration in RIF

Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group

This study was designed as a prospective randomized controlled trial with the involvement of 200 RIF group patients.The procedure will perform by administering 30 mIU of Leucostim®(Filgrastim \[G-CSF\] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL will be infused into the endometrial cavity in the same way in the control group. The standard ICSI procedure will use for all patients, and fresh cycle embryos will be transferred on the third or fifth day.

Eligibility Criteria:
Inclusion Criteria:

* Women under the age of 40 who met the RIF definition
* Follicle-stimulating hormone (FSH) levels were \<15 IU/mL

Exclusion Criteria:

* Patients with congenital uterine anomalies
* Patients with Asherman's syndrome
* Patients with uterine cavity distorted by myoma or endometrial polyps
* Patients with confirmed endometriosis or endometrioma
* Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle cell anemia, malignancies, chronic neutropenia)
Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast Cancer

To determine the overall objective response rate of pegylated liposomal doxorubicin （Lipo-Dox）combined with cyclophosphamide/5-FU as second-line treatment in patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically proved breast cancer with metastatic disease

Exclusion Criteria:

* life expectancy less than 3 months.
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of open-angle glaucoma
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Under 18
* Pregnant
* Other protocol-defined exclusion criteria may apply
Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants

The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants


Eligibility Criteria:
Inclusion Criteria:

* Healthy full term infants

Exclusion Criteria:

* experienced congenital or chromosomal disorders
* neonatal morbidities, or metabolic illness
Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder

t is recognized that cortisol, a hormone produced by the adrenal glands, is a marker that is elevated in patients with psychological disorders, particularly anxiety. On the other hand, Temporomandibular Disorders (TMD) are a condition with a multifactorial etiology, in which emotional disturbances play a crucial role.

Therefore, the aim of this study is to evaluate whether patients with TMD have higher levels of salivary cortisol compared to the general population.

Initially, an assessment will be conducted using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol to determine whether the patient suffer of any kind of Temporomandibular Disorder. Based on the results, individuals will be classified into two groups: the study group, consisting of patients with TMD, and the control group, composed of individuals without the disorder.

Those who agree to participate will be required to sign an informed consent form. Subsequently, a saliva sample will be collected for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who attend the dental clinic of the Faculty of Medicine of University of Coimbra

Exclusion Criteria:

* Pregnant women, minors and non-autonomous individuals
Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery

To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for vitreoretinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective retinal surgery under general anesthesia

Exclusion Criteria:

* ASA physical status \> Grade II,
* psychiatric conditions,
* neurological impairment,
* deafness with whom communication would be difficult in the postoperative period,
* clotting abnormalities,
* contraindications for regional anesthesia,
* drug abuse,
* history of allergy to the study drugs,
* previous vitreoretinal or strabismus surgery,
* endophthalmitis, or inflammatory eye pathology
* taking analgesics, antiemetics or drugs that might affect hemodynamics
Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair

The purpose of this study is to investigate the contents in blood sampled from surgery site during hip replacement compared with blood sampled from abdominal aortic surgery. Is there any difference in pro-inflammatory cytokines (IL-1beta, IL-6, IL-8 and TNF-α), complement activation (C3a)?

Patient (n= 10) scheduled for total hip replacement or hemiprosthesis and patient (n=10) scheduled for abdominal aortic surgery.

Primary outcome:

Pro-inflammatory cytokines (IL-6, IL-8 and TNF-α) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.

Secondary outcome:

Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-4

Exclusion Criteria:

* Patient using corticosteroids, NSAIDs or Cox-II inhibitors
* Patients under 18 years
* Patients who are included in pharmaceutical studies
* Opioids-, benzodiazepines-, antiepileptic drugs-, alcohol- and α2-agonists abuse
* Pregnant and breastfeeding women
* Patients with known hypersensitivity for opioids, propofol or volatile anesthetics
* Patients with serious arrhythmias (atrial fibrillation/flutter is acceptable)
* Uncontrolled hypertension, serious psychiatric disease
* Patients with unstable angina pectoris or myocardial infarction the last month before inclusion
* Acute abdominal aortic surgery (acute dissection or rupture)
* Planned laparoscopic abdominal aortic aneurysm surgery
* Transfusion of blood products last month before surgery
* Glucocorticoid users
Safety of Fentanyl TAIFUN Treatment

A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate hte Safety of Fentanyl TAIFUN Treatment after titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy


Eligibility Criteria:
Inclusion Criteria:

* Age 18 Years or older
* A medically documented diagnosis of cancer
* Use of a fixed round the clock dose of opioid as maintenance therapy with a dose equivalence of at least 60mg of oral morphine/ day, or at least 25 mcg of transdermal fentanyl/ hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily. Current opioid treatment for at least 7 days prior to randomization
* Current use of opioid medication for BTP
* At least 4 episodes of BTP per week, with peak intensity of at least 4 on the NPS at pain onset. No more than 4 BTP episodes per day.
* PIFR of at least 20L/min
* Karofsky Performance Status of 40 or better
* Life expectancy of at least 12 weeks
* Written Informed Consent

Exclusion Criteria:

* Uncontrolled or rapidly increasing BTP
* Symptomatic intracranial tumors or cerebral metastases
* Persistent symptomatic asthma
* Patients unable to use the inhaler
* Inadequate lung function, as defined by PEFR \<60%
* Hypersensitivities, allergies or contraindications to fentanyl or the study medication components
* A recent history of alcohol or substance abuse (in the past 1 year)
* Radiotherapy to the thorax within 30 days of the beginning of the titration phase
* Cognitive impairment or any neurological of psychiatric disease which could compromise the ability of the patient to complete the assessments
* Participation in any clinical study with an experimental drug within 30 days of randomization
* Any clinical condition or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug
* Pre-menopausal women who are not surgically sterile and/or have a positive pregnancy test at baseline visit and/ or are of child bearing potential and are not using a reliable method of birth control or do not plan to continue using this method throughout the study and/or who are nursing
Investigations of New Markers in Patients With Shock

Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs).

Shock is a severe deficiency in oxygen at the cell level which could lead to the death. The treatment strategy relies on the profile of plasma lactate level, which the kinetics and metabolism are inadequate for evaluating the treatment efficiency without delay. Hence, it is now critical to identify adequate markers of dysoxia.

The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate.To this purpose, a multiple approach is undertaken with the analysis of 3 independent markers of cellular ischemia : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs). Indeed, the characteristics of HIF as marker of cell dysoxia, and MPs as markers of cell apoptosis, combined with cDNA seem providing complementary information in order to describe the consequences of shock as well as the response to treatment.

Samples of patients will be collected (from rest of blood sample collected for other measurements) at each step of the management of these patients. The evolution of these markers will be compared with that of lactate plasma levels (standard of care). Subgroup analysis will be undertaken in relation with the cause of shock state (septic, cardiogenic, hemorrhagic).

Eligibility Criteria:
Inclusion Criteria:

* shock state defined by a rise of plasma lactate level (\> 2 mmol/L)and/or refractory low blood pressure in the volume expansion requiring an introduction of catecholamines
* admission in intensive care \< 6 hours

Exclusion Criteria:

* Pregnancy
* presumed survival lower than 48 hours
* absence of central venous way and arterial catheter
Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases

Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus exists regarding which biopsy methods are appropriate for specific procedures.

In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.

The primary end point of this study was the determination of the sensitivity and the complication rates of the invasive methods, Abrams needle pleural biopsy, tru-cut needle pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pleural diseases

Exclusion Criteria:

* Patients with other lung diseases
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.

All patients will be included just after implantation and will then be followed during 48 months after inclusion.

At each on-site or remote follow-up visit (1 to 3 months, 6, 12, 24 and 48 months), performances of the remote monitoring functions and the cardiac pacing system itself will be measured, and safety will be monitored during the whole clinical investigation duration.

Eligibility Criteria:
Inclusion Criteria:

1. Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement)
2. Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
3. Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead
4. Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by the patient and planned to be activated
5. Patient reviewed, signed and dated the ICF

Exclusion Criteria:

1. Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
2. Patient with permanent AF
3. Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
4. Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
5. Minor age patient (i.e. under 18 years of age)
6. Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
7. Patient unavailable for the follow-up visits scheduled
8. Non-menopausal women
Investigating the Effects of Diet and Physical Activity on Esport Performance

A randomized, counterbalanced intervention study in esport players.

The study will test whether i) the consumption of two different carbohydrate drinks and ii) the performance of regular high-intensity interval training will impact esport performance and metabolic profile.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Male or female aged 18-45 years
* Healthy
* Participants have to be part of an esport association and/or regularly participate in tournaments

Exclusion Criteria:

* diabetes mellitus type 1 or 2 (T1DM or T2DM)
* medication which impacts glucose metabolism or visual perception
* health issues like cardiovascular diseases, severe orthopaedic conditions or neurological impairments
* food allergies or intolerances, e.g. fructose malabsorption
Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques

The study aims to identify metabolites present in intervertebral discs colonized by C. acnes from patients with low back pain and degenerative disc disease, correlating them with their clinical, radiological and demographic profiles.


Eligibility Criteria:
Inclusion Criteria:

* low back pain lasting longer than 3 months;
* MRI findings of degenerative lumbar discopathy (DDL) performed less than 6 months after inclusion in the study;
* indication for open surgical treatment, with isolated microdiscectomy or associated with lumbar arthrodesis;
* failure of conservative treatment for at least 6 weeks and/or progressive neurological deficit

Exclusion Criteria:

* History of open lumbar spine surgery at any stage of life;
* presence of chemotherapy or pulse therapy with corticoids;
* patients with immune deficiency;
* patients undergoing previous intradiscal therapies (nucleotomy or discography);
* patients undergoing previous endoscopic surgery;
* patients with a history of previous spinal infection treated with antibiotics in the 6 months prior to inclusion in the study;
* use of antibiotics in the 2 months prior to the surgical procedure
CNP-103 in Adolescent and Adult Subjects Ages 12-35 with Recently Diagnosed (within 6 Months) Stage 3 Type 1 Diabetes (T1D)

This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.

  2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive. 3. Documented diagnosis of T1D within 180 days prior to study enrollment according to American Diabetes Association \[ADA\] criteria.

  4. Subjects with a peak stimulated C-peptide of \>0.2 nmol/L measured from a mixed meal tolerance test (MMTT). Note: this test result may be obtained from an MMTT conducted within 1 month of planned first dose.

  5. For subjects on any medication used to treat the symptoms of T1D (e.g., corticosteroids), subjects must be on a stable dose for a minimum of 1 month prior to enrollment and must agree not to increase their dose from Screening Visit through End of Study Visit unless reviewed and approved by the medical monitor and the site investigator

Exclusion Criteria:

* Subjects who have used the following medications:

  a. Within 5 half-lives or 90 days prior to first dose, whichever is shorter: i. Oral immunomodulators: (i.e., cyclosporin, azathioprine, methotrexate) ii. B cell depleting immunotherapy (e.g., Rituximab) iii. Other anti-diabetic agents besides insulin (e.g., Verapamil). Insulin is allowed if on a stable dose for 30 days prior to the Day 1 dose). b. Within 6 months prior to first dose: i. T cell modifying immunotherapy (e.g., Abatacept, Etanercept, Ustekinumab) within 6 months prior to the first dose c. Within 12 months prior to first dose: i. T cell depleting immunotherapy (e.g., Teplizumab) within 12 months prior to the first dose d. Exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site Investigator.

  2. Subjects who present with diabetic ketoacidosis (DKA) at the time of diagnosis. Note: any MMTT must be performed no sooner than 2 weeks and up to 4 weeks after DKA diagnosis.
Psychotherapy for Intermittent Explosive Disorder

The goal of this study is to examine the effectiveness two forms of psychotherapy (also known as "talk therapy" ) for individuals with anger and aggression problems. Anger and aggression are everywhere - on the road, in the schools, at little league games, at home, and at work. In this study we are testing usefulness of anger management techniques in reducing symptoms of Intermittent Explosive Disorder (IED) and impulsive, aggressive behavior.

Qualified participants will be randomly assigned to 12 1-hour sessions of either cognitive-behavioral therapy or supportive psychotherapy.

Participation in this study will require 13 visits over approximately 4 months with a 3 follow-up session. Therapy is provided at no cost and each study participant will receive a comprehensive psychological assessment. Two types of talk therapy are being offered in this study. One form of therapy focuses on thought and behaviors associated with anger and aggression. This type of therapy is known as cognitive behavioral therapy. The other type of therapy focuses on the individuals' feeling about their anger /aggression and the situations that lead to this anger. This is known as supportive therapy. The form of therapy you are given will be randomly determined (like by flipping of a coin).

Eligibility Criteria:
Inclusion Criteria:

* Have problems with anger, temper outbursts, being irritable, getting in trouble at work or at home because of impulsive/aggressive behavior.
* Between the ages of 18 and 55.
* Meet other eligibility requirements as outlined by the research protocol.

Exclusion Criteria:

* Lifetime diagnosis of psychosis or bipolar disorder
* Current diagnosis of substance dependence or major depressive disorder.
* Current suicidal or homicidal ideation,
* Recent use of selective serotonin reuptake inhibitors (past month) or other psychotropic medication (past two months)
* Recent psychotherapy for aggression (past six months.)