cyrilzakka/clinical-trials huggingface dataset:
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients

The investigators determined whether

1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements
2. radiographically secure implant fixation is achieved with this new stem
3. the bone content is preserved at the baseline level or above at the final follow-up
4. these procedures are associated with early failure and complications.

To attempt reduction of stress shielding and thigh pain as well as to improve survivorship, a new short, metaphyseal-fitting cementless anatomical femoral stem was developed. The question arises as to whether it is possible to obtain rigid fixation of the stem without diaphyseal fixation in the young as well as in the elderly patients. The purpose of this study was to determine the clinical and radiographic results of the new short, metaphyseal-fitting cementless anatomical femoral stem in the young as well as in the elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion Criteria:

* Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient
* Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
* Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia

This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.

The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase.
* Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months.
* Evidence of stable symptomatology at least 3 months.

Exclusion Criteria:

* Female subjects who are pregnant or breastfeeding.
* Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results.
* Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.
Sound Estimation and Accuracy Task

Participants will be assigned to complete computerized estimation tasks for which there is a component of accuracy, such as estimating the duration of sounds. Participants will be told that the task is used as an early diagnostic tool to detect those at risk for a medical condition (e.g., Parkinson's disease, Alzheimer's disease). Instructions will be given to participants telling them that accuracy on the task is associated with the disease, whereas those who are not at risk of the disease tend to either overestimate or underestimate the duration of the sounds. The investigators examine whether such instructions about the purpose and diagnosticity of the tasks biases participants' responses to the tasks, leading them to purposefully be more inaccurate in their estimates.

Participants will be assigned to complete computerized tasks for which there is a component of accuracy, such as estimating the length, in time, of sounds. Participants will be told that the task is used as an early diagnostic tool to detect those at risk for a medical condition (e.g., Parkinson's disease, Alzheimer's disease). Instructions will be given to participants telling them that accuracy on the task is associated with the disease in question, whereas those who are not at risk of the disease tend to either overestimate or underestimate the duration of the sounds. The investigators examine whether such instructions about the purpose and diagnosticity of the tasks biases participants' responses to the tasks. The investigators collect additional survey measures as statistical controls and potential explanatory variables for variation in the performance on the tasks, and also test whether financial incentives for accuracy on these tasks improve the accuracy of responses to these tasks.

Following the task, all participants will be told that the tasks used are actually NOT diagnostic of the diseases in question, and that deception was used to learn how people respond to instructions about how a task can be used for diagnostic purposes.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Able to access tasks on computer
* Able to hear sounds played on computer

Exclusion Criteria:

* Computer speakers absent or not functioning
A Patient Navigation Program for Addressing Disparities in Breast Cancer Care

This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.

PRIMARY OBJECTIVE:

I. Implement a patient navigation program in the Roswell Park Breast Clinic focused on underserved women with a first cancer diagnosis of breast cancer or ductal carcinoma in situ (DCIS) (n=126).

SECONDARY OBJECTIVE:

I. Systematically address barriers to care by connecting women with multiple barriers of care with a first diagnosis of breast cancer or DCIS to supportive services and culturally appropriate resources.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Have a confirmed diagnosis of breast cancer or DCIS
* Have not had a previous diagnosis of cancer
* Currently identify their gender as woman or female
* Was assigned female sex at birth (AFAB)
* Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention

Exclusion Criteria:

* Participants under the age of 18
* Participants who are not suspected of or diagnosed with breast cancer or DCIS
* Participants who have had a previous diagnosis of any cancer
* Participants who identify their gender as other than woman or female
* Participants who were assigned male sex or intersex at birth
* Unwilling or unable to follow protocol requirements
The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery

Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing spine surgery in general anaesthesia.
* Postoperative pain \> 50 mm on the VAS scale during mobilization.
* Patients who have not received analgesia 1 hour prior to inclusion.
* ASA 1-3.
* BMI \> 18 og \< 40.
* Fertile women need a negative HCG urine test.
* Patients who have given their written consent to participate and understand the contents of the protocol.

Exclusion Criteria:

* Participation in another clinical trial.
* Patients who do not speak and/or understand Danish.
* Fertile women with a positive HCG urine test.
* Allergy to the drugs used in the trial.
* Alcohol or medicine abuse, assessed by investigator.
* Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)
* Daily chlorzoxazone treatment.
* Known or suspected porphyria.
Occupational Respiratory Allergies and Gene-environment Interactions

The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma.

Secondary purposes are:

* to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration;
* to estimate medical-social becoming of diagnosed work-related asthma after one year;
* to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.

Participants with work related asthma or suspected work related asthma will obtain a precise diagnosis concerning severity and control of respiratory disorder and also the possible effect of professional environment on the disorder. Their medical care and medico-legal care, in case of recognition of occupational disease, could be ameliorated.

In general, this study will allow the harmonization of diagnostic care and medical, medico-professional and medico-legal management of cases of work related asthma in specialized hospitals.

Eligibility Criteria:
Inclusion Criteria:

- Patient consulting for suspected work-related asthma in one of hospitals participating to the study

Exclusion Criteria:

* Patient refusing to participate
* Pregnant or breastfeeding women
* Individual in life-threatening emergency
* Hospitalized patient
* Patient in a health or social institution
* Person deprived of liberty
* Person with total occupational disability
* Retired person
* Person diagnosed as non-asthmatic
* Asthmatic person already enrolled in a clinical trial of bio-therapy to treat asthma
Energy Metabolism and Cost of Physical Activities Using Whole Body Calorimeter

The aim of this study is to assess energy regulation of overfeeding and performing common household activities in young Chinese males using whole-body room calorimetry up to 10 hours.

This study will require participants to stay in the room calorimeters for up to 5 hours on each of the 3 test sessions. The participants are to avoid intense physical activity/alcohol and to record their food intake for the day prior to test day. They will record their food intake for the day prior to test session 1 in a food diary (to be provided to them on the day of screening). Records will be used to ascertain participants' food intake patterns. They will report to Clinical Nutrition Research Centre (CNRC) in the morning after an overnight (10-12 hours) fast. Basic anthropometric measurements will be taken at the start of the test session before participants enter the room calorimeter. The room calorimeter is a 13.5 m3 chamber furnished with features to give an impression of a normal room with windows on three sides of the chamber for outside view and visual contact with researchers. It has a full sized foldaway bed, a fold-down writing table, an office chair, a built-in sink and mirror, a portable freeze-dry toilet bowl, a television, a telephone, computer network connection, an intercom system. During their stay in the room calorimeter, energy expenditure will be measured based on recorded oxygen consumption and carbon dioxide production over 10 hours. Participants are allowed to rest, sit and move freely, except sleep or exercise during their stay. On each of the 3 test sessions, the subjects will perform up to 4 common household activities (e.g. mopping floor, washing dishes, etc) 1 hour after consuming the light breakfast. On test session 1, the light breakfast consist of biscuits and a juice drink and will be provided to the participants after they have undergone assessment of metabolism at rest for approximately 45 minutes in the room calorimeter. On test session 2 and 3, the same light breakfast will be provided after approximately 15 minutes after they have entered the room calorimeter. During their 4-5 hours stay in the room calorimeter, they will simulate a particular household activity for up to 20 minutes and rest for 30 minutes before continuing with another household activity and so on for up to 4 different household activities at each of the test sessions.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Ethnic Chinese
* Age between 21 to 39 years
* Body mass 60 to 70 kg
* Body height 165 to 175 cm
* Normal resting blood pressure \~120/80 mmHg
* Normal fasting blood glucose level \<5.5 mmol/L
* Do not train for or partake in competitive sports
* Do not have any major diseases
* Not on any prescribed medication
* Willing and able to consume all test meals
* Not allergic to any food ingredient found in all test meals
Pyrotinib in Women With High-risk in Early Stage Breast Cancer

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.

However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in this study and sign the informed consent form；
2. Female or male patients, aged ≥ 18 years, and ≤75 years;
3. ECOG PS score: 0-1;
4. Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
5. Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
6. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
7. Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer
2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
3. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. A history of allergy to the drugs in this study；
5. Unable or unwilling to swallow tablets
6. History of gastrointestinal disease with diarrhea as the major symptom.
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy

Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations

Perineal lacerations and episiotomies are common after vaginal birth. Surgical repair of these conditions can cause discomfort and anxiety for the post-partum woman.

The purpose of this research is to determine if the use of virtual reality (VR) during repair of a perineal laceration or episiotomy can decrease the anxiety level of the woman. Other parameters that will be measured will be vital signs, time of procedure, and pain level.

84 eligible healthy women after spontaneous or instrumental vaginal birth will be enrolled. Allocation will be randomized by previous sealed envelopes. 42 in the VR group and 42 in the control group. The 42 women in the VR group will have the device placed band in use before the onset of the procedure. Anxiety level will be measured post-procedure by (STAI) State Inventory Anxiety Trait. Pain will be measure by VAS.

Assuming a significant anxiety level of 60% in women undergoing repair of a perineal laceration of episiotomy, in order to demonstrate a reduction to 30% in women using VR with a power of 80% and alpha of 0.05, 42 women will be needed in each group.

Eligibility Criteria:
Inclusion Criteria:

* Post-partum vaginal delivery, spontaneous or instrumental
* Episiotomy or 1st or 2nd degree perineal tear
* informed consent

Exclusion Criteria:

* Cesarean delivery
* 3rd or 4th degree perineal tear
* no informed consent
A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis

The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have been diagnosed with relapsing MS
* Participants must have one of the following

  1. at least 1 documented relapse within the previous year, or
  2. at least 2 documented relapse within the previous 2 years, or
  3. at least 1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months prior to screening.

Exclusion Criteria:

* Have had a diagnosis of primary progressive MS
* Have a history of another clinically significant neurological disease
* Had a relapse of MS within 30 days prior to randomization.
Long-Term Development of Muscular Dystrophy Outcome Assessments

This is a 24-month, observational study of up to 1000 participants with Limb Girdle Muscular Dystrophy (LGMD), Myotonic Dystrophy Type 2 (DM2), and late onset Pompe disease (LOPD).

Limb Girdle Muscular Dystrophy (LGMD) comprise a group of disorders made up of over 30 mutations which share a common phenotype of progressive weakness of the shoulder and hip girdle muscles. While the individual genetic mutations are rare, as a cohort, LGMDs are one of the four most common muscular dystrophies.

Myotonic Dystrophy Type 2 (DM2) is a more recently discovered, rare type of myotonic dystrophy. DM2 is inherited in an autosomal dominant pattern and is caused by an unstable CCTG expansion. DM2 affects the muscles and other body systems (e.g. heart and eyes).

Pompe disease is a rare, multisystemic, hereditary disease which is caused by pathogenic variations in the GAA gene. Late onset Pompe disease (LOPD) refers to cases in which hypertrophic cardiomyopathy did not manifest or was not diagnosed at or under the age of 1 year. LOPD is characterized by skeletal muscle weakness which causes mobility problems and impacts the respiratory system.

The overall goal of this project is to extend prior observational studies conducted within the GRASP LGMD network to define the key phenotypes as measured by standard clinical outcome assessments (COAs) for multiple rare types of muscular dystrophy to hasten therapeutic development.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 6-50 years at enrollment
2. Clinically affected (defined as weakness on bedside evaluation in a pattern consistent with proximal weakness)
3. Genetic confirmation of a LGMD, DM2, or LOPD
4. FVC above 30% of predicted

Exclusion Criteria:

1. Any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator
2. Participation in a clinical trial receiving an investigational product
Umbilical Vein Needle Catheterization for Endotracheal Intubation.

The investigators describe a simple and efficient method to give a premedication in the delivery room, using the umbilical vein, directly punctured through Wharton's jelly.

The umbilical vein is punctured to inject drugs efficiently. The access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. The investigators used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. The investigators report 5 cases of intubations in the delivery room using this method to administer the premedication.

Eligibility Criteria:
Inclusion Criteria:

* All the patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS).

Exclusion Criteria:

* Refusal of legal owners
Effects of Milk Powder Intervention on Blood Glucose Control and Fluctuation in Middle-aged and Elderly People With Pre-diabetes

This study aims to conduct a 8-week intervention involving one formula milk powder for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control and fluctuations in comparison to interventions using regular milk powder.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 75 years, regardless of gender.
2. Impaired fasting glucose (5.6 mmol/L ≤ FPG \< 6.9 mmol/L) or glycated hemoglobin (HbA1c) between 5.7-6.4% (39-47 mmol/mol).
3. Resided in Guangzhou for the past six months and no plans to relocate or travel outside the city in the next month.
4. Signed informed consent form and voluntarily agreed to participate in the project.

Exclusion Criteria:

1. Patients with a confirmed diagnosis of diabetes who are currently taking glucose-lowering medications (e.g., insulin, GLP-1 receptor agonists, or SGLT2 inhibitors).
2. Individuals with lactose intolerance or dairy product intolerance.
3. Pregnant, planning to become pregnant within the next three months, or currently breastfeeding.
4. Weight change \> 5% in the past three months or plans to lose weight or change dietary habits.
5. Alcohol consumption \> 40g/day.
6. Individuals with communication barriers, cognitive impairments, or other conditions that may prevent them from completing the study procedures.
7. Severe diseases that may affect participation in the study, including but not limited to endocrine disorders, severe cardiovascular or cerebrovascular diseases, cancer, metabolic diseases, etc.
8. Participation in or current involvement in other clinical trials within the past three months.
9. No use of antibiotic medications within the past three months.
The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales

The investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific subjective scales.

Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA). However, the availability of PSG is limited, particularly in developing and / or least developed countries. Sub-mental ultrasonography is stepped forward with its practical and cheap nature and its widespread use.

The investigators aimed to perform sub-mental ultrasonography to the patients who underwent to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA scales.

Eligibility Criteria:
Inclusion Criteria:

* Patient who consented for sub-mental ultrasound

Exclusion Criteria:

* Any pharyngo laryngeal anatomic abnormality
* Previous history of Obstructive sleep apnea treatment
* Previous history of surgical intervention to the pharyngo laryngeal anatomic area