cyrilzakka/clinical-trials huggingface dataset:
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System

The goal of this observational study is to collect clinical and radiological data to monitor the safety and performance of the ROMAX hip resurfacing system. The main parameter that will be measured is the rate of revisions at 10 years.

This single-center, post-market, prospective, longitudinal, and uncontrolled cohort study aims to evaluate the survival rate of the Medacta ROMAX hip resurfacing system, particularly focusing on dislocations and the potential consequences of wear over a 10-year period. Additionally, the study will assess clinical performance through patient-reported outcomes (PROMs) and analyze the migration behavior of the device using the CTMA method in a subgroup of 40 patients. The study will include a total of 150 cases, with 40 patients undergoing CTMA analysis at 3 years post-surgery. Eligible patients will be informed during preoperative visits and included upon signing the consent form, prior to surgery. Participation in the CTMA subgroup is optional and does not affect overall study inclusion. Follow-ups will be conducted at 3 months, 1, 3, 5, and 10 years. Data collection will include clinical scores, clinical and radiological data related to preoperative and postoperative status, and perioperative surgical details.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for hip resurfacing, suitable for the implantation of a Medacta ROMAX hip resurfacing system according to the manufacturer's defined indication for use.
* Aged between 18 and 65 years at the time of surgery.
* Ability and willingness to provide written informed consent for participation.

Exclusion Criteria:

* Active infection
* BMI \> 40
* Mental illness, when the known pathology is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress, or complete follow-up appointments and exams.
* Significantly deformed anatomy (at the surgeon's discretion)
* Osteomalacia where the fixation of an uncemented implant is contraindicated
* Active rheumatoid arthritis
* Osteoporosis
* Metabolic disorders likely to impair bone formation and for which the fixation of an uncemented implant is contraindicated
* Muscle atrophy or neuromuscular disease
* Known allergy or hypersensitivity to the implant material
* Any patient who cannot or does not wish to give informed consent to participate in the study
* Patients whose chances of regaining independent mobility would be compromised by known concomitant medical issues.
Identify the Clinical Significance and Potential Implications of Peritoneal Washing Cytology (PWC) in Patients With Pancreatic Cancer

Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are largely due to a high incidence of local or peritoneal recurrence even after curative R0 resection. If occult microscopic metastasis or residual cancer could be predicted correctly and identify the high risk of peritoneal recurrence, we may have chance to treat these patients by different multimodal locoregional or adjuvant therapy to improve the treatment outcome.

The purpose of this study has three specific aims: (1) to determine the relationship between peritoneal washing cytology (PWC) results and clinicopathologic parameters of pancreatic cancers, (2) to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, (3) to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic cancers, other non-ductal pancreatic cancers , and benign pancreatic tumors (as negative control population) operated in Surgical Department after IRB proof and receiving patients' informed consent.

Exclusion Criteria:

* Pregnant women
Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics

The purpose of this observational study is to analyze the extent and characteristics of drug interactions (focusing on azole antifungals and echinocandins) and genetic polymorphisms on tacrolimus blood concentrations in renal transplant recipients in order to provide a reference for the appropriate adjustment of tacrolimus dosing regimen to reduce the incidence of adverse drug reactions and rejection, and to improve the survival of transplanted kidneys.

In this study, investigators investigated the effects of CYP3A5 and CYP2C19 gene polymorphisms on the trough concentration of tacrolimus after renal transplantation in recipients who were on a tacrolimus-based immunosuppressive regimen (tacrolimus + mescaline + glucocorticosteroid) after their first renal transplantation; investigators investigated the effects of antifungal drugs on the trough concentration of tacrolimus, and investigators also analyzed the effects of genetic factors on the drug-drug interactions between antifungal drugs and tacrolimus, with the aim of providing a basis of reference for the rational use of tacrolimus and antifungal drugs in the clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with first kidney transplantation and intact CYP3A5 genotype;
2. Renal transplant recipients taking a tacrolimus-based triple immunosuppressive regimen (tacrolimus + sodium mescaline enteric-coated tablets + glucocorticoids) postoperatively;
3. Age ≥ 18 years.

Exclusion Criteria:

1. Missing and incomplete clinical information and postoperative follow-up data;
2. Multi-organ combined transplantation and secondary transplantation;
3. Postoperative simultaneous joint application of other drugs that affect the blood concentration of tacrolimus or voriconazole or caspofungin (e.g. pentoxifylline capsules, rifampicin, etc.);
4. Severe impairment of liver function or severe gastrointestinal diseases, gastrointestinal resection surgery, malabsorption syndrome;
5. Pregnant and lactating women;
6. Recipients with significant rejection of the transplanted organ or death due to other reasons within 1\~2 months after surgery;
7. Poor compliance and accuracy of results (e.g., irregular blood collection times).
Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China

Breast cancer related lymphedema (BRCL) is a common complication following breast cancer treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities, impaired physical mobility, mental discomfort, reduced quality of life and erysipelas. Therapy of BRCL is divided into conservative and operative methods. However, all the above method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety of this method will be also assessed.


Eligibility Criteria:
Inclusion Criteria:

Breast cancer diagnosis regardless of the date of operation and identified unilateral arm lymphedema Stage Ⅱ of lymphedema according to the standard of International Society of Lymphology The patient is able to read, understand, and complete questionnaires. Completed radiotherapy and/or chemotherapy at least 2 months prior to inclusion The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.

Exclusion Criteria:

Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal failure Untreated deep venous thrombosis in the arm Iodine allergy Pregnancy Psychiatric disorders
Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty

In total hip arthroplasty several approaches can be used. The newly introduced minimally invasive anterior approach is supposed to cause less damage to tendons and muscles. At the same time there are reports that there are more complications when this approach is used. The direct lateral approach is the most used in Norway and is well documented. There are however those who postulate that there is to high risk of damage to the gluteus medius causing Trendelenburg gait. In the investigators hospital both the anterior and direct lateral approach is used with good result. The investigators main study hypothesis is that there is no difference between the use of anterior or direct lateral approach i total hip arthroplasty in regards to postoperative function and pain, complications, radiological finds (X-ray and MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria:

* Previous surgery on affected hip
* No mental disability preventing follow-up
Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals

This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental frovatriptan therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs, the subject will institute a 4-day hormone-free interval (HFI). In an attempt to prevent/lessen the severity of headache during the HFI, subjects will be randomized to prophylactic administration of a triptan or placebo during this period. If no BTB/BTS occurs after 80 days of continuous pills, the subject will institute a 4-day HFI during which they will be randomized into triptan or placebo groups.

The purpose of this research study is to examine the effects of continuous oral contraceptive pills and frovatriptan on headaches that occur around the time of your period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped they may get headaches. This study will look if taking frovatriptan around the time of the period will affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for migraine headaches.

This study is a prospective pilot trial.The study will last approximately 35-39 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Woman may be on birth control pill (OC), patch or NuvaringTM (vaginal ring) taken in the traditional 21/7 or 24/4 manner, which means ever month they have a period. If they are taking it continuously (without a period), you must be willing to take your birth control 24/4 (4 days taking hormone free interval, HFI) for 2 months.
* If you are not on OCs, patch or NuvaringTM you must have a period every 21-40 days.
* You must not want to get pregnant for 12 months.
* Women have headaches around the time of their period.

Exclusion Criteria:

* BMI \> 38
* If you smoke and are age 35 years old or greater or if are under 35 years old and smoke over 10 cigarettes a day
* If you have or had an aura with your headaches (An aura is a temporary sensation, like bright lights that come before you experience the headache.)
* Headaches are not occurring during the time of your period.
* Blood Pressure \> 140/90 or you take more than a single antihypertensive medication (excluding diuretics) and are age 40 or greater.
* Contraindications to combination estrogen/progestin hormonal contraception.
* Desire to become pregnant in the next 12 months.
* Refuse to avoid any ergot-based medication, triptan medication or isometheptene/midrin during their hormone free interval or the one day before the hormone free interval
* Stroke
* Breast Cancer
* Blood clots in your legs, lung or anywhere else in your body
* Diabetes mellitus
* Heart attack
* Liver disease
* Lupus Erythematosus
Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma

Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. Caspase-8 is a key enzyme involved in controlling cell death. This study examines the importance of caspase-8 in oral cancer.

Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. The caspase family of enzymes are the key performers of controlled cell death and caspase-8 is frequently mutated in oral cancer. This study will perform DNA sequencing to determine if the gene is wild-type (not mutated). The abundance of inactive (uncleaved) and active (cleaved) caspase-8 will be determined. The levels of the proteins that caspase-8 interacts with (including caspase-3) will be determined. Results will be correlated with tumour stage, patient outcome and the presence of immune cells and other microscopic features. This will improve the understanding of the importance of caspase-8 in oral cancer.

Eligibility Criteria:
Inclusion Criteria:

* Oral cancer
* Sufficient follow up data

Exclusion Criteria:

* Patient has indicated that they do not wish their tissue to be used for research.
* . The quantity or quality of tissue is too little or poor to provide adequate material without significant reserve.
* The material contains bone.
Physiological Upper Eyelid Laxity

This is a prospective, single-center study in normal subjects aged 20 to 89 years.

The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old) measured with the method of McNab and studying it according to her customary side of sleep. In addition, we evaluated a method for measuring tarsal laxity.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 89 years
* be free
* be able to give informed consent

Exclusion Criteria:

* History of facial paralysis, upper palpebral trauma or palpebral surgery
* History of sleep apnea syndrome
* Impossibility to give consent
* Pregnant or lactating women
* Persons enjoying enhanced protection and persons deprived of their liberty by a judicial or administrative decision
68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma

This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT.

This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. Each patient will receive one dose of 68Ga-NY104 and one dose of 18F-FDG by intravenous route. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent, blinded interpretations. Imaging interpretations and a composite reference standard will be used to estimate the sensitivity of each modality. The tumor uptake will also be compared for matched lesions.

39 patients will be recruited in Peking Union Medical College Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 y
2. Histopathological diagnosis of clear cell renal cell carcinoma
3. Metastatic disease confirmed by histopathology or typical appearance of multifocal metastatic disease
4. Expected survival of at least 6 months
5. ECOG ≤ 2
6. Written informed consent provided for participation in the trial
7. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
2. Patients on HIF antagonist treatment \< 3 months before 68Ga-NY104 PET/CT. CA9, which encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated by HIF-1. HIF antagonist, such as Belzutifan, might affect the expression of CAIX and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is required for HIF antagonist.
3. Pregnancy or breastfeeding.
4. Severe claustrophobia.
Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.


Eligibility Criteria:
Inclusion Criteria:

* Male or female children between and including 18 -20 months of age at the time of the vaccination.
* Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
* Written informed consent obtained before study entry from the parents or guardians of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
* Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
Morbidity and Mortality Follow Up for the Scleroderma Lung Study

The primary intent of this study is to add to the body of knowledge on scleroderma patients with interstitial lung disease. While lung disease is recognized as the leading cause of death amongst patients with scleroderma, there is not a large body of literature describing the long-term morbidity and mortality rate of these scleroderma patients. For this reason, the investigators are following participants of the Scleroderma Lung Study (NCT00004563) after their participation in that study was concluded. In addition, the investigators will assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung Study experienced progression of their scleroderma-related lung disease following the end of the study.

Retrospective and prospective data will be collected about patients who participated in the Scleroderma Lung Study (SLS). An attempt will be made to include all of the participants of the Scleroderma Lung Study, who were reported as alive at the end of that study.

A total of 158 subjects (79 per treatment arm) were randomized on the original Scleroderma Lung Study. Of those, 109 subjects completed the study. A single telephone interview with the participants to assess the occurrence of severe events and a review of the participant's medical records may be conducted. The outcome information will be combined with information collected about all participants in the SLS study. The data being collected includes information on mortality, development of cancers, development of organ failure, and performance status.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the Scleroderma Lung Study
Use of Rosiglitazone in the Treatment of Endometriosis

The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.

There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial.

Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women ages 18 - 45 years.
* Regular menstrual cycles (24-35 days).
* Pelvic pain ≥ 3 months with cyclical component.
* Negative pregnancy test and must use nonhormonal contraception.
* Non-lactating.
* No history of liver disease.
* Consent to participate in the study.
* Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation within the past 4 years.

Exclusion Criteria:

* Major psychiatric conditions or the abuse of alcohol or drugs which would make it difficult for the subject to complete study procedures.
* Active or prior infection with hepatitis, human immunodeficiency virus (HIV) infection, or history of high-risk activities (e.g., IV drug abuse) which would increase risk to laboratory personnel. Of note, no testing for hepatitis or HIV will be performed as part of this study and all tissues will be handled and discarded as if they were potentially infected.
* Patients with liver dysfunction (elevated liver enzymes \> 2 times the upper limit of normal).
* Presence of pre-existing malignancy, including carcinoma of the breast or uterus.
* Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
* Elevated WBC.
* NYHA functional class I-IV heart failure.
* Diabetics.
* Known pregnancy or positive pregnancy test.
Adaptive Rock Climbing

The goal of this clinical trial is to assess changes in functional and psychosocial outcomes following a 12-week adaptive rock-climbing program for children with congenital upper limb differences. The main questions it aims to answer are

* Assess functional outcomes following a 12-week adaptive rock-climbing program.
* Assess psychosocial outcomes following a 12-week adaptive rock climbing program.
* Assess barriers to participation in adaptive sports.

Participants will complete 12-week adaptive rock climbing program.


Eligibility Criteria:
Inclusion Criteria:

* Parents 18 years and older.
* English or Spanish speaking.
* Participants with unilateral or bilateral congenital upper extremity disorders of limb formation differences ages 6-16.

Exclusion Criteria:

* Any patients younger than 6 years or older than 16 years, patients not fluent in English or Spanish, or patients with parents younger than 18 years.
Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia

Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations.

Supraglottic Airway Devices (SADs) refer to a wide range of medical devices that can act as a passageway for oxygenation, ventilation, and administration of anesthetic gases and may be deemed an alternative to Endotracheal Tubes (ETTs).

Oropharyngeal sealing pressure (OLP) provides insight into the risk of gastric insufflation and aspiration risk. It is considered a measure of adequate performance and successful placement based on the premise that the SAD is sited properly in the hypopharynx after blind placements, and it is a useful comparator between SADs.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 2 to 12 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I and II.
* Scheduled for elective orthopedic operations in a supine position under general anesthesia.

Exclusion Criteria:

* Patients with a known history of gastro-oesophageal reflux disorders.
* Full Stomach.
* Anticipated difficult mask ventilation or intubation.
* Body mass index "BMI" exceeding 20% of the ideal.
* A history of chest problems.
* History of the gastrointestinal tract or thoracic surgeries.