cyrilzakka/clinical-trials huggingface dataset:
Dynamic ROM Via Gait Analysis and 3D Fluoroscopy in THA With Different Head Diameters

Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM due to the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers or sawbones) or using mathematical modeling in computer simulations. These studies are limited by the lack of soft tissues and muscle activations in the models. This study will clinically assess the effect of prosthetic head diameter on patient capability of performing movements which require extreme arcs of motion of the hip joint. Therefore, the research questions are:

* What role do soft tissues play in limiting ROM?
* Can prosthetic impingement really occur in a well positioned THA?
* Can a bigger head diameter alone reduce the risk of impingement?

This will be a prospective comparative randomized double-blind Study (both patient and the clinical engineer performing the gait analysis will be blind with respect to the prosthetic head diameter implanted). Patient recruitment will last 12 months and the Study will have a follow-up period of 12 months. A total number of 45 patients will be recruited. Patients will be randomly allocated into three groups: the first group will undergo THA with a 28mm diameter head (Pinnacle Acetabular System, with a ceramic on ceramic - CoC - bearing), in the second group THA will be performed using a 36 mm diameter head (DeltaMotion), finally patients in the third group will undergo THA with a 40 mm diameter head (DeltaMotion). Patients will be operated by three surgeons of the same hospital according to the same surgical procedure and using the same direct lateral approach. All patients will receive a Corail stem and will follow the same rehabilitation program.

* Primary endpoint: Gait analysis and fluoroscopy will provide quantitative information of prosthesis in vivo performance, e.g. what is the arc (degrees) of active or passive motion when prosthetic impingement occurs?
* Secondary endpoint(s): these analyses will also allow to: 1) assess ROM of the operated hip versus contralateral non operated hip and the effect of prosthetic head diameter and any correlation to hip functional scores validated and commonly used in the Literature; 2) set reproducible criteria for in vivo fluoroscopic analysis of ROM in THA patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral primary or secondary hip arthrosis indicated for THA;
* Men and female, age between 35 and 55 years old;
* BMI smaller than 30;
* Patients able to understand the protocol and to sign the informed consent.

Exclusion Criteria:

* Child-bearing female;
* Patients with also controlateral hip arthritis;
* Neurological patients, because of possible alteration of neuro-muscular control of the replaced hip;
* Patients treated with joint replacement at any other lower limb articulation
The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia

Spinocerebellar ataxia (SCA) is a group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. A key pathogenic mechanism of SCA is the repeated expansion of cytosine - adenine - guanine (CAG) trinucleotides in the coding region of specific genes. These repeated expansions are translated into abnormally large polyglutamine (PolyQ) tracts in proteins. These polyglutamine (PolyQ) tracts can cause changes in the excitability of the cerebral cortex in SCA patients. Quantitative electroencephalogram analysis (qEEG) is a modern type of electroencephalogram analysis that uses complex mathematical algorithms to process, transform, and analyze EEG signals, bringing new technologies for EEG signal feature extraction: specific frequency band and signal complexity analysis, connectivity analysis, and network analysis. It is sensitive to early neurodegenerative lesions. Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients. Currently, the exploration of the quantitative electroencephalogram characteristics of SCA patients is still insufficient.


Eligibility Criteria:
Inclusion Criteria:

1. Spinocerebellar ataxia patients confirmed through genetic testing
2. Patient aged 18-75
3. Patients who can walk independently (with the aid of a cane/walker) without assistance from others.
4. The SARA score exceeds 3.

Exclusion Criteria:

1. Patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.)
2. Patients with significantly abnormal clinical indicators identified during screening
3. Patients concurrently participating in another clinical study
4. Patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders
5. Patients with severe heart disease
6. Patients who are wheelchair users
7. pregnant woman
8. Patients who cannot establish their identity or have limited legal capacity
9. Patients with contraindications for rTMS, including metallic objects in the head, history of neurosurgery, ferromagnetic bioimplants, metal coatings, history of seizures, autism, current use of protease inhibitors or other medications that may increase the risk of rTMS-induced seizures.
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery

The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.

Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy.

The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult cardiac surgery patient

Exclusion Criteria:

* Preoperative continuous use of laxatives
* Known anatomic or functional gastrointestinal disorder
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

This study will evaluate the dose-response relationship and safety of VX-150 in treating acute pain following bunionectomy.


Eligibility Criteria:
Key Inclusion Criteria:

Before surgery:

* Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m\^2)
* Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After surgery:

* Subject reported pain of greater than or equal to (\>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
* Subject is lucid and able to follow commands
* All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before surgery:

* History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* History of abnormal laboratory results \>=2.5\*upper limit of normal (ULN)
* History of peripheral neuropathy
* A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
* Prior medical history of bunionectomy or other foot surgery on the index foot
* History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

After surgery:

* Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Other protocol defined inclusion/exclusion criteria may apply
Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder

The main purpose of the study is to conduct an initial feasibility evaluation of the new Internet-based EAET treatment manual. We will include 50 patients with somatic symptom disorder to take part of the treatment for nine weeks through the Internet. A within-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly. Feedback on content, process and potential caveats will be collected using surveys and written evaluations from the participants at post-treatment. Linear mixed models will be used to investigate trajectories of change in symptoms and processes.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* A total score ≥10 on the PHQ-15
* A diagnosis of SSD according to the DSM-5, i.e ≥1 of the 3 of: disproportionate thoughts about the somatic symtom, persistently high level of anxiety, or excessive time and energy devoted in regard to symptoms or health concerns
* Symptom duration ≥6 months
* Written statement from a medical professional that states that a medical evaluation has been conducted.

Exclusion Criteria:

* Alcohol or substance addiction
* A diagnosis of a psychological condition that might require other treatment (e.g., psychosis, suicidality, etc)
* Other severe medical condition that might require other treatment
* Ongoing psychological intervention or psychotherapy that may interfere with the psychological treatment
* Ongoing medical treatment that may interfere with the psychological treatment
Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary

This study will determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks with carboplatin.

Rationale: The combination of the chemotherapy drugs paclitaxel and carboplatin is one of the most common combination regimens used in clinical practice for cancer. These agents are used for a variety of cancers. The current study builds on previous research about treatment schedules for administering these agents to reduce toxicity and optimize efficacy. The phase I and II portions of the current study combine paclitaxel and carboplatin with capecitabine in patients. Researchers are seeking to identify the highest dose of capecitabine and paclitaxel in combination with carboplatin for this patient population, as well as to gather information about preliminary efficacy.

Purpose: The phase I portion of this study will evaluate the maximum tolerated dose of capecitabine and paclitaxel in combination with carboplatin for patients. The phase II portion of this study will assess the objective response rate in patients using the same treatment combination. Toxicities will be closely measured in both phases of the study.

Treatment: Patients in this study will be given capecitabine, carboplatin, and paclitaxel. Capecitabine will be given through oral pills. Carboplatin and paclitaxel will be given through intravenous infusions. Treatment drugs will be given on a four-week cycle. Carboplatin will be administered on day 1, paclitaxel weekly for the first 3 weeks, and capecitabine twice daily on days 8 through 21 of each cycle. No treatments will be given during the fourth week of each treatment cycle. During the phase I portion of the study, patients may receive different doses of capecitabine and paclitaxel since the purpose is to identify the maximum tolerated dose of each drug in combination with carboplatin. Once the maximum tolerated dose of these agents is identified during phase I, the phase II portion of the study will begin. Treatments will be discontinued due to disease growth or unacceptable side effects. Several tests and exams will be given throughout the study to closely monitor patients.

Eligibility Criteria:
Inclusion Criteria for Phase I:

* All advanced solid malignancies
* Any prior chemotherapy permitted
* Performance Status 0-2

Inclusion Criteria for Phase II:

* Adenocarcinoma of unknown primary
* No prior chemo permitted
* Performance Status 0-2
The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers

This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects.

The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.

Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers

Exclusion Criteria:

* 1. History of chronic disease or serious disease 2. Subject with severe psychological or mental illness 3. Not enough washing-out period for previous therapy 4. Other.
A Study of TNM001 in Chinese Healthy Preterm and Term Infants

The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants. The main questions it aims to answer are:

* the safety and tolerability of TNM001 injection
* the pharmacokinetic (PK) profile of TNM001

This phase Ib/IIa study is designed to assess the safety, tolerability, and pharmacokinetics (PK) profile TNM001 in healthy preterm and term infants. This study will also compare the incidence of Respiratory Syncytial Virus（RSV） infection between different doses of TNM001 and placebo, which will be used to select the dose to be studied in the later phase of clinical trials of TNM001. Approximately 30 subjects will be randomized and will be dosed once on Day 1 and followed up until Day 151. Around 6 investigational study centres participate in the study.

Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy preterm infants and term infants within 1 year old of age
2. Infants who are in the first RSV infection season at the time of randomization

Key Exclusion Criteria:

1. Any fever or acute illness within 7 days prior to dosing
2. LRTI prior to randomization
3. Received any anti-RSV monoclonal antibody or RSV vaccine
4. Any other circumstances that, in the opinion of the investigator, may interfere with the assessment of the study drug or the interpretation of the study results
5. The subject is a child of the investigator or his/her subordinate study personnel or relatives or sponsor staff
CSF Pharmacokinetics of Ondansetron

Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution.

Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years old;
2. Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
3. Ability to provide informed consent

Exclusion Criteria:

1. Not giving consent to participate in the study;
2. Patients with history of or current hepatic or renal insufficiency;
3. Patients with BMI ≥ 33;
4. Patients with heart failure or active arrhythmias;
5. Patients with severe systemic disease that is a constant threat to life;
6. Contraindication or allergy to ondansetron;
7. Pregnancy or lactation.
8. Prisoners
Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.

The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease.

Among several symptoms in patients with multiple myeloma, the bone disease is one of the most common symptoms that approximately 80 percent of the patients experience. Multiple myeloma is different from other tumors in that several osteoclast activating factors (OAF) released from multiple myeloma cells resorb bone and, at the same time, activation of osteoblast is inhibited, leading to unbalance of breakdown and formation of bone. Activation of osteoclast and inhibition of osteoblast brings about bone fractures, osteoporosis, hypercalcemia, bone pain and spinal cord compression. Those symptoms are directly related to patients' quality of life. Therefore, they are the important therapeutic targets for multiple myeloma. Various types of bisphosphonate agents are used for the treatment of the bone disease in patients with multiple myeloma. This is a prospective (a study where the participants are identified and then followed forward in time), multi-center, Phase 4, observational study (studies that record specific events occurring without any intervention from the researcher) in order to analyze the change in bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) before and after the use of bortezomib injection by using an enzyme-linked immunosorbent assay (ELISA) in serum. The adverse events will be assessed through the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE V3). The patients will receive bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days under usual clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included.

Exclusion Criteria:

* Patients who are hypersensitive to the study drug or any component of the study drug or with a history of the hypersensitivity
* Patients with severe hepatic impairment
* Women who are pregnant
a4b7 Integrin in Eosinophilic Esophagitis

The overall objective of this preclinical study is to further the investigators mechanistic understanding of the role that the α4β7 and mucosal addressin cell adhesion molecule (MAdCAM-1) pathway plays in mediating eosinophil recruitment in EoE. To accomplish this, the investigators aim to (1) determine the baseline and dynamic patterns of α4β7 integrin expression on circulating and tissue eosinophils in EoE and in the setting of non-EoE esophageal eosinophilia (e.g., reflux esophagitis) and (2) determine the complete profile of eosinophil integrin molecules that may play a role in active EoE.


Eligibility Criteria:
Inclusion Criteria:

1. Able to give written informed consent
2. Male or female patients aged 18-65 years at time of screening
3. Confirmed active EoE at screening or within 8 weeks prior to baseline visit, as defined by esophageal mucosal eosinophils ≥15 per high power field (HPF, 400X magnification) despite at least 4 weeks of proton pump inhibitor (PPI) therapy with omeprazole 20 mg twice daily or the equivalent. updated 14APR2015 Page 8 of 19
4. Within the week prior to dosing, patient has one of the following symptoms of moderate, or worse, severity: dysphagia, vomiting, regurgitation, abdominal pain, chest pain/heartburn.
5. Maintained on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups.
6. Willing and able to comply with all clinic visits and study-related procedures
7. Able to understand and complete study-related questionnaires

Exclusion Criteria:

1. Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg-Strauss, parasitic infection)
2. History of abnormal gastric or duodenal biopsy or documented GI disorders other than EoE (e.g., celiac disease, Crohn's disease or H. pylori infection)
3. History of the following GI surgeries: fundoplication, gastric surgery or surgery for esophageal atresia
4. Use of systemic immunosuppressive or immunomodulating agents (oral prednisone, anti-immunoglobulin E (IgE) monoclonal antibody (mAb), methotrexate, cyclosporine, INFα, or anti-TNF) within six months prior to study entry.
5. A stricture on endoscopy that prevents passage of the endoscope
6. Participation in any investigational drug or device study within 30 days prior to study entry.
7. Female subjects who are pregnant or nursing.
8. Chronic infections such as HIV, hepatitis B or C, active mycobacterial (TB) or fungal infections.
9. Neoplasm or a history of malignancy in the preceding 5 years.
10. Concurrent infection or disease that may preclude assessment of eosinophilic esophagitis.
Investigation of Non-CE Marked Intermittent Catheters.

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users.

For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Minimum 18 years of age and with full legal capacity
* Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
* Ability to self-catheterize
* Written informed consent, signed letter of authority and signed secrecy agreement given

Exclusion Criteria:

* Participation in any other clinical study during this investigation
* Symptoms of urinary tract infection as judged by the investigator
* Any know allergies towards ingredients in the products
* Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)