cyrilzakka/clinical-trials huggingface dataset:
Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study

The goal of this study is to enroll 100 participants with Primary Progressive Multiple Sclerosis (PPMS) that have joined the MURDOCK Study Horizon 1.5 (Duke IRB Pro00011196) and the Multiple Sclerosis cohort (Duke IRB Pro00023791). All 100 participants will complete a biannual collection of a follow up questionnaire and blood/urine collection for a period of 5 years.

Unlike Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS) in which patients experience a remission or lessening of their symptoms, Primary Progressive Multiple Sclerosis (PPMS) is characterized by progression of disability from onset, with no, or only occasional and minor, remissions and improvements. The age of onset for the primary progressive subtype is later than for the relapsing-remitting, but similar to mean the age of progression between the relapsing-remitting and the secondary progressive - around 40 years of age. Because of its prevalence, RRMS represents the largest basis for basic and clinical MS research. Therefore, drugs have primarily been developed to slow disease progression in RRMS and SPMS patients. No treatment has been proven successful in treating primary progressive MS.

The MURDOCK-MS collection represents a unique opportunity to carry out detailed biomarker research on PPMS patients and, to the knowledge of this investigator and his colleagues in the field, would represent an exceptional cohort that is not available elsewhere in the US or the rest of the world. Aside from first in disease sampling, the serial, biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression. This progressive etiology would provide valuable insight into PPMS development and may also shed light on SPMS progression.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the MURDOCK Study Horizon 1.5 (Pro00011196)
* Enrolled in the Multiple Sclerosis Cohort (Pro00023791)
* Diagnosed with Primary Progressive Multiple Sclerosis
* At least 18 years of age

Exclusion Criteria:

* Participants not willing to participate or sign informed consent
Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults

Across the world, the most common cause of dying in the ICU is a disease called "sepsis". Sepsis is a disease in which the body's protective response to infection becomes too intense, unnecessarily damaging important organs in the body. Kidney damage during sepsis is particularly bad, as a person's chance of survival drops significantly when he or she develops kidney failure. This study plans to learn more about how to detect (and thus prevent) kidney failure early in sepsis. The current tests doctors use only detect kidney failure once it's already happened. We must therefore find better ways of detecting kidney failure earlier, when there is still a chance to protect the kidneys.

In this study, patients will provide a one-time sample of urine. We will check this urine for signs of a protein called "heparanase", which we believe is important in early kidney failure. We will then see if high heparanase activity in urine predicts the risk of developing kidney failure. We will compare results from patients with sepsis with results from patients with trauma, allowing us to determine if heparanase is only important in sepsis kidney failure.


Eligibility Criteria:
Inclusion Criteria:

1. Septic shock or major trauma. Septic shock will be defined by standard criteria including (a) the presence of the systemic inflammatory response syndrome (SIRS), (b) evidence of infection, and (c) treatment with vasopressor medications for \> 4 hours despite \> 30 ml/kg intravenous crystalloid resuscitation. As a critically-ill comparator group, we will also enroll adult patients admitted (within 24 hours prior to screening) to the Denver Health Surgical ICU with major trauma, as defined by an Injury Severity Score of \> 15.

Exclusion Criteria:

Exclusion criteria include anuria, prisoners, absence of a routinely-inserted urine collection device, or gross hematuria. Additionally, patients with known genitourinary malignancy will be excluded, given that cancers are known to overexpress heparanase. Additional exclusion criteria include age \< 18 years, and pregnant women.
A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon

The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon


Eligibility Criteria:
Inclusion Criteria:

* Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia)
* and having an initial positive parasitaemia to Plasmodium falciparum
* Other aetiologies of the presenting symptoms excluded
* Written consent from parent(s)

Exclusion Criteria:

* Prior side effects to either artesunate or quinine administration
* Severely malnourished children
* Concomitant infection
Single Incision Versus Standard Laparoscopic Splenectomy

This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy.

The hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.

This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for splenectomy. We will offer enrollment to several institutions provided they reach institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 30 patients will give us a power of 0.8 with an α of 0.05. Thus operative time is the primary outcome variable by definition. This is recorded and reported in MINUTES.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Secondary outcome measures include days in the hospital (measured in days), doses of analgesics (measured in doses) and perception of cosmesis as recorded by a scar assessment form which will be filled out by the patient and/or parents at 6 weeks and 6 months. This is a validated quality of life survey with 39 questions and each has 4 categories from best to worst.

Eligibility Criteria:
Inclusion Criteria:

* Need for splenectomy

Exclusion Criteria:

* Splenomegaly
Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.

The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group


Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary total hip arthroplasty for hip osteoarthritis, primary or secondary osteoarthritis (dysplasia or post-traumatic) or osteonecrosis
* Good enough understanding of outpatient management and patient adherence to post-operative instructions
* Sufficient patient complicance to medical orders
* Living and hygiene conditions, at least, equivalent to the ones the hospital provides
* To be of age
* Non opposition to the protocole participation

Outpatients group :

- Patient schedulded to undergo outpatient THA

Inpatients group :

- Patient schedulded to undergo inpatient THA because of not fiting the following items :

* Less than an hour distance of a Health Center that provides appropriate care with regard to the surgery
* Rapid access to a phone
* Designated driver and caretaker available (at least the first night after discharge from the hospital) after the procedure Or turning down outpatient THA

Exclusion Criteria:

* Anaesthetic point of view :

  * ASA physical status ≥ 3 and : unstabilize disease with appropriate treatment or lack of preoperative mutual agreement between anesthesiologist and surgeon or not inconsiderable interaction between the operation and the disease or its treatment
  * Pre-operative Hb \< 12 (♀) \< 13 (♂) g/L (NB : no Hb control before discharge except if excessive blood loss ; Hb \< 10g/L contraindicates outpatient surgery)
  * Opioid chronic pre-operative therapy or opioid addiction
* Surgical point of view :

  * Ambulatory pre-operative status requiring use of two crutches or walking frame / distance walked \< 30 m
  * THA procedure for femoral neck fracture requiring
  * Additional operative technic needed
* Adult safeguarding.

Exclusion criteria applies to all in and outpatients.
The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Golf Swing

The purpose of the study is to investigate if osteopathic manipulative treatment (OTM) improves the golf swing of the participants. Study participants will be randomized into three groups, we will stratify by age and gender to make them as uniform as possible. One group will receive no intervention other than a 10-minute break between the pre and post measurements. A second group will receive a sham intervention where the doctor will pretend to give the participant OTM. The third group will receive real OTM.

Participants will perform a sample of 10 golf swings pre and post intervention which will be measured by a golf simulator. They will also complete a brief health history and pre/post self-evaluation of their swing.


Eligibility Criteria:
Inclusion Criteria: Adult golfers (18 years old or over) -

Exclusion Criteria: Anyone under 18 years, people that do not golf.

-
Clinical Observation Study With the SBG Stem

This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.


Eligibility Criteria:
Inclusion Criteria:

* patients requiring the implantation of the SBG hip stem

Exclusion Criteria:

* general medical contraindications to surgery
* acute or recent infection of joint
* atrophy or deformation of upper femur
* muscular atrophy or neuromuscular disease
* pathologic fractures
* per- and subtrochanteric fractures
* revision of failed hip endoprosthesis
* hypersensitivity to used materials
* any conditions preventing stable anchoring of the hip prosthesis
Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fasting Conditions

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under Fasting Conditions

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult aged more than 19 at the time of screening
2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) \< 30.0kg/m²

   # BMI=Weight(kg) / Height(m)²
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
6. Those who agree to double contraception method from the 1st administration of the investigational product until 7 days after the last administration of investigational product.

Exclusion Criteria:

1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, impacted teeth, wisdom teeth).
2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
6. Those who have taken any drugs that may affect the clinical trial within 10 days.
7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
8. Those who are deemed insufficient to participate in this clinical study by investigators.
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

In this study, four new tablet versions of two compounds will be investigated.

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.

Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days.

The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)


Eligibility Criteria:
Inclusion Criteria:

* Male.
* Aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study interventions or related products.
* Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.
* Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
* History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms

In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD.

The study design starts with a baseline period of 2 weeks, includes 6 weeks of a 'strict' FODMAP diet (no blinded), followed by a 9 week 'reintroduction' phase (single blind). Based on the patients' symptom results following each of these challenges, patients will then follow the 'moderate' FODMAP diet, where the FODMAPs that did not trigger any symptoms during the challenge tests can now be consumed. Finally patients follow 2 weeks of a diet 'moderate' in FODMAP levels (no blinded). Blood and stool samples will be collected during the complete trial at several timepoints. In addition, before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test.

Eligibility Criteria:
Inclusion Criteria:

* patients with functional dyspepsia (postprandial distress syndrome)
* written informed consent
* 18-70 years

Exclusion Criteria:

1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
2. Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
3. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD)
4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
5. Females who are pregnant or lactating are excluded from the study.
Testing of a Mobile Web App to Decrease Posttraumatic Stress Symptoms in Women After Sexual Assault

Interventions are available to all adult women sexual assault survivors to reduce the risk of pregnancy and sexually transmitted infection, yet no interventions are provided to reduce posttraumatic stress. This pilot study tests the ability of a smartphone-based web app to prevent and reduce posttraumatic stress in women sexual assault survivors.


Eligibility Criteria:
Inclusion Criteria:

* Present for emergency care within 72 hours of sexual assault
* Receive a sexual assault nurse examiner (SANE) exam
* Alert and oriented

Exclusion Criteria:

* Unable to consent due to intoxication, serious injury preventing ability to hear, speak, or see to consent, or other causes
* Prisoners
* Pregnant women
* Women living with assailant who plan to continue living with assailant
* Women with fractures from the assault
* Admitted patients
* Women who do not have a smartphone with continuous service for the past 12 months
* Inability to read and speak English
* No mailing address
* SANE exam took place \>72 hours ago
* Patient previously enrolled in the study
Safety and Efficacy of a Drug Delivery System in Glaucoma

Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman 21 years of age or greater
* Open angle glaucoma or ocular hypertension
* Corrected visual acuity in each eye of 20/200 or better

Exclusion Criteria:

* Previous glaucoma intraocular surgery or refractive surgery
* Planned contact lens use during the study
* Clinically significant ocular or systemic disease that might interfere with the study
* Use of chronic corticosteroids by any route
Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery

Chronic low back pain (CLBP) is a prevalent condition causing significant pain, disability, and reduced quality of life. While various treatments like exercise, NSAIDs, and spinal manipulation are recommended, their effectiveness is limited. Epidural steroid injections can provide short-term relief but may not be cost-effective and have associated risks.

Dexmedetomidine (DXM) is a selective α2-adrenergic agonist with analgesic properties. It has been used as an adjuvant to anesthetics and analgesics to enhance pain relief and reduce opioid consumption. Using DXM in conjunction with local anesthetics for regional blocks has shown promising results in improving analgesia and functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of daily activities;
* Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of quality of walking and life;
* Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks maintained on systemic analgesics;
* Patients who were free of exclusion criteria were enrolled in the study.

Exclusion Criteria:

* The presence of osteolytic vertebral lesions;
* The Presence of previous surgical intervention;
* The presence of allergy to the studied drugs;
* Patients of ASA grade \>II.
Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.

Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth factors receptors and ligands, including expression of both PDGF and PDGF receptors. Drugs that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer. Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases. Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine. Based on pre-clinical and phase 2 clinical studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.

Eligibility Criteria:
Main Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
2. Chemo naïve patients with advanced/metastatic disease
3. Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.
4. Men and women, age \>18 years
5. Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
6. Patient should be able and willing to comply with study visits and procedures as per protocol.
7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.

Main Exclusion Criteria:

1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or in situ cervical cancer
2. Any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
3. Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline
4. Treatment with any investigational agent within 4 weeks prior to baseline