cyrilzakka/clinical-trials huggingface dataset:
Polarstem Cementless Hip Stem

Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™.

Efficacy evaluations:

* Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) \[7, 8\], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
* Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration

Safety evaluations:

* Intra- and perioperative device-related adverse events (AE) and complications up to discharge
* Postoperative AE up to 10 years

Eligibility Criteria:
Inclusion Criteria:

* Patient has no general medical contraindication to surgery
* Informed consent to participate in the MCO signed by the patient
* Routine radiographic assessment is possible
* Patient is likely to comply with study follow-up requirements
* Primary total hip replacement (THR) to the affected side, unilateral or bilateral

Exclusion Criteria:

* Previously failed endoprosthesis and /or THR components in relevant hip
* History of infection in the affected joint; systemic infections
* Grossly insufficient femoral or acetabular bone stock in the involved hip
* Charcot joint disease or other severe neurosensory deficit
* Severe spinal disorders
* Age of patient at date of surgery \> 75 years
* High comorbidity
* Cemented acetabular cup
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.

Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone.
* Patients selecting the IUD need to identify themselves as desiring long-term contraception.

Exclusion Criteria:

* Current pregnancy,
* Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days,
* Current behavior suggesting a high risk for pelvic inflammatory disease
* Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B)
* Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that distort the uterine cavity,
* Mucopurulent cervicitis,
* A previously placed IUD that has not been removed
* Genital bleeding of unknown etiology
* Ovarian, cervical or endometrial cancer,
* Small uterine cavity
A Study to Evaluate the Safety, Tolerability and Dose-Response Relationship of HRS-9190 in Healthy Subjects

This is a single-center, open-label and dose-escalation study to evaluate the safety, tolerability and dose-response relationship of HRS-9190 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects aged 18 to 45 years (inclusive).
2. Subjects must have no pregnancy plans for the next three months and agree to use highly effective contraception throughout the trial period.
3. Capable of understanding the study requirements and willing to provide written informed consent.

Exclusion Criteria:

1. Presence of any clinically significant condition that could interfere with trial participation.
2. History or current diagnosis of neuromuscular disorders.
3. Major surgery within 6 months pre-screening, or planned surgical procedures during the study.
4. Vaccination received within 1 month prior to screening or planned vaccination during the trial period.
5. Participation in another investigational drug trial within 3 months pre-screening.
6. Clinically significant abnormalities in screening/baseline physical examinations.
7. Positive alcohol breath test at screening.
8. Pregnancy or lactation status (for female subjects).
9. Investigator-determined unsuitability for study participation or predicted protocol non-compliance.
Brain-Computer Interface and Mind-Body Awareness Training

Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).

The PI's hypothesis is that MBAT will improve performance in SMR based BCI.

In this protocol, we will test the PI's hypothesis that MBAT including yoga will improve the ability for subjects to concentrate on control the SMR thus improving the performance of BCI.

Subjects will be recruited for short term MBAT and then undergo BCI training. The performance of subjects with MBAT will be compared with those without MBAT to test the hypothesis. Procedures involved include 6 weeks yoga classes with at least 3 classes per week, and a EEG brain noninvasive brain computer interface study.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old healthy subjects

Exclusion Criteria:

* History of traumatic brain injury/brain lesion, history of neurological deficit or neurodegenerative disorder, or history of epileptic seizures.
Biomarkers for Prediction of Tumor Response to Radiotherapy

This study aims to explore potential biomarkers for prediction of therapeutic outcomes in patients with solid tumors after radiotherapy

Patients pathologically confirmed with solid tumors that requires radiotherapy or surgery will be recruited to this study. Tumor samples were obtained from patients underwent surgery to establish the baseline status of biomarker assessed. Peripheral and microbiota will also be collected before and after surgery. For patients undergoing radiotherapy, tumor biopsy as well as collection of blood samples and microbiota will be performed during the course of treatment. These biological specimens will be used for assessment of tumor phenotypes and for exploration of potential biomarkers that could predict the tumor response to therapeutics and prognsis in patients with solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Pathological proven diagnosis of solid tumors
* Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
* Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

* History of autoimmune diseases
* History of immunotherapy
* Prior radiation therapy that would result in overlap of planned radiation therapy fields
* Will receive immunotherapy during the course of radiotherapy
* Contraindications for biopsy, such as high bleeding risk
The Effects of Home Use of Transcutaneous Electrical Nerve Stimulation on People With Knee OA and or Chronic Knee Pain

The purpose of the research is to see if the use of transcutaneous electrical nerve stimulation (TENS) at home would reduce knee pain and swelling in people with knee OA and/or chronic knee pain.


Eligibility Criteria:
Inclusion Criteria:

* The inclusionary criteria for subjects: Male or Female with the age of 45 years or older, ultrasonography scale of 0-3 for grading of primary Knee OA of the knees, pain perceived as a minimum of 3/10 and a maximum of 7/10 weekly average during the baseline period on a 0-10 active VAS pain scale, no phobia of electrical stimulation, no pain or anti-inflammatory medication will be taken during the study. Injury/pain that began at the knee a minimum of 6-weeks before entering the study.

Exclusion Criteria:

* Exclusion criteria for the subjects: Pregnancy, Diabetes Mellitus, Neuropathy, Smoker, Uncontrolled HTN, Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months before enrollment, Arthritis (RA) in the area to be treated by TENS, Allergic to tape/electrodes, Dementia, history of knee joint replacement or tibial osteotomy, undergoing physical therapy, any other major joint pain (e.g., back, hip, or ankle) that could limit functional ability, contraindications to TENS (pacemakers, dermatological conditions, and abnormal sensation in the knees), severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumbar disc, herniation, and rheumatoid arthritis) or do not utilize stairs in daily living and unable to walk without ambulatory assistive devices. The candidate will be disqualified as a subject for the study if less than 5 days of pedometer use or less than 5 days VAS reporting within the prior week's baseline period.
The Cytogenetic Constitution of Embryos Resulting From Immature Oocytes (M1)

To examine the chromosomal number content in the blastomeres of embryos achieved from fertilization of immature oocytes at MI stage recruited following COH for IVF.

comparison of the genetic number content of embryos and their quality in terms of cleavage rate and morphological score reached after fertilization of immature oocytes at MI stage whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a variable length of time.

Patients undergoing routine IVF, following informed consent, donated some of their unusable, immature- MI stage oocytes for our research. Following in vitro maturation for up to 2, 4, 8 and 24 hours after harvest, all immature oocytes in these 4 study groups underwent intracytoplasmic donor sperm injection (ICSI), whether they extruded their polar body (MI-PB or rescued MI) or not (arrested MI). Oocyte fertilization rate after 24 hours and embryonic development in terms of cleavage rate and morphology were assessed, for another 48 hours. Then the whole embryo was prepared for molecular cytogenetic evaluation using FISH (Fluorescence in situ hybridization) analysis of chromosomes x, y and 18.

Eligibility Criteria:
Inclusion Criteria:

* Patients with presence of immature oocytes after ART stimulation

Exclusion Criteria:

* Patients with less than total 7 oocytes
A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain

This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive Venlafaxine or placebo during the course of the trial. All subjects will, in fact, receive placebo for the first two weeks. All subjects will then be placed on 150-225 mg per day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment).

Study Hypothesis:

In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo (more than 30% reduction after Venlafaxine treatment).


Eligibility Criteria:
Inclusion Criteria:

* Age 50 - 80 years
* Physician diagnosis of OA in hip, knee or spine
* Significant activity limitation due to pain for at least one month on the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) and average pain more than 5/10 on Brief Pain Inventory despite adequate treatment with acetaminophen or NSAIDs (This will identify an OA group with significant psychological distress and a desire for treatment).
* Depression status is not restricted, but will be monitored with PRIME-MD interview and the SCL-20. We anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.

Exclusion Criteria:

* Cannot read and write English
* Significant cognitive impairment
* History of psychosis or mania
* Current suicidal ideation
* Current substance abuse or dependence
* Current use of opioids or any antidepressant medication
* Use of investigational drug within the past month
Measurement of Vaginal Squeeze Pressure in Incontinent Patients

The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.

Several techniques had been proposed for pelvic floor muscles assessment, however none of them were able to measure the two main functions of these muscles: rising and force of compression. Vaginal palpation is frequently used in clinical evaluation routine and especially the modified Oxford score, but some articles question the Oxford scale sensitivity and its correlation with objective force contraction measurements.

Methods: 45 patients with urinary incontinence treated at the Uroginecology Ambulatory Service of the Hospital de Clínicas de Porto Alegre were included. The patients had been submitted to vaginal palpation using the Oxford score, assessed by a skilled physical therapist, and to the compression force measurement by means of an air filled ballonet connected to a pressure transducer. The two evaluations had been carried in the same day.

Eligibility Criteria:
Inclusion Criteria:

* Stress, urge or mixed stress and urge urinary incontinence.
* Understanding and signing a letter of informed consent

Exclusion Criteria:

* Urinary tract infection.
* Genitourinary surgery during the previous six months.
* Pregnancy or in puerperal period.
* BMI \> 40
Osteopontin in Metastatic Breast Cancer Patients

OPN plays an important role in various aspects of malignancy, particularly those involved in tissue invasion and metastasis, and OPN levels have been associated with aggressive¬ness in several cancer types, including breast cancer. Tumor response to treatment is a predictor of prognosis and overall survival for cancer patient population the investigators assigned osteopontin as potential contributors in breast cancer.

Analysis of polymorphisms in the OPN regulatory region:

The PCR amplification of the promoter regulatory region from the extracted DNA by using the following primers -3 (forward primer 5" -CAA GCT ACT GCA TAC TCG AAA TCA CA-3" ; reverse primer 5" - ACA ACC AAG CCC TCC CAG AAT TTA-3" ). PCR was performed using 50 ng DNA as a template under the following conditions: 95°C for 10 min, then 36 cycles of 94°C for 30 s, an annealing temperature for 60 s, and 72°C for 60 s, with a final extension at 72°C for 15 min. After affinity membrane purification using the QIAquick Gel Extraction kit (Qiagen, Carlsbad, CA, USA), the PCR products were subjected to cycle sequencing with the respective forward and reverse primer using an automated ABI 310 DNA sequencer.

Measurement of serum level of osteopontin:

OPN level were measured using Enzyme linked immnosorbent (ELISA) Kit supplied by IBL (Immuno-Biological laboratories Co. Ltd., Japan). 30 normal females were conducted with matched age with a median osteopontine serum level of 15 so, this level was assigned as a cut off value.

Pretreatment serum level and polymorphism of oteopontine was correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.

Eligibility Criteria:
Inclusion Criteria:

* de novo metastatic breast cancer patients recruited from Oncology center Mansoura University and clinical oncology department, Mansoura University Hospital All included patients were presented with disseminated visceral +/- bone metastasis (visceral crisis)

Exclusion Criteria:

* brain metastasis was excluded
Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting

This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary prevention based on their total cardiovascular risk. No visits or interventions, additional to the routine clinical practice, were requested or performed.

An observational, multicenter, prospective study of Lebanese adult (18 years or older) hypercholesterolemic patients administered generic Rosuvastatin (Superstat®).

Eligible newly diagnosed hypercholesterolemic patients took generic Rosuvastatin as prescribed by their treating physician. Assigning patients to generic Rosuvastatin was decided within the current practice and medical indication and was independent from the recruitment into the study.

Patients were followed-up at the clinic as per the standard practice of care. Each patient was followed-up for a period of 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Patients with dyslipidemia requiring statin therapy according to CV risk factors as per the ESC/EAS 2011 guidelines for primary or secondary prevention
* Patients provided written informed consent

Exclusion Criteria:

* Age \<18 years
* Statin use in the past 3 months
* Any contraindication to HMG-CoA reductase inhibitors
* Co-administration of non-statin lipid lowering agent (ezitimibe, fibrates, niacin, omega 3)
* Conditions which may cause secondary dyslipidemia
* Any of the following abnormal laboratory tests:

TG level of \> 400 mg/dL, Abnormal liver enzymes (AST or ALT) ≥ 3 ULN, Abnormal serum creatine kinase (CK) \> 5 ULN
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study

Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor):

* Change in attitudes towards quitting smoking
* Change in smoking behavior
* Participant feedback

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Current daily cigarette smokers (at least 10 cigarettes per day)
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 11 and above, or, Android 5.0 and above with operating system Android 5.0 and above)
* Willing to sign the Informed Consent Form

Exclusion Criteria:

* Pregnancy
* Participation in a previous study sponsored by Carrot Inc
Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.

The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.

* Treatment period 1: Single oral dose of 30 mg nifedipine GITS and 8 mg candesartan as loose combination (Treatment A)
* Treatment period 2: Single oral dose of 60 mg nifedipine GITS and 16 mg candesartan as loose combination (Treatment B)
* Treatment period 3: single oral dose of 60 mg nifedipine GITS and 32 mg candesartan as loose combination (Treatment C) Before any study drug administration in each treatment period, subjects were fasted from food for at least 10 hours. Subjects continued fasting until at least 4 hours after study drug administration. The wash-out phase between treatments was 5 days.

The blood collection period for pharmacokinetics after administration was 48 h. Afterwards, subjects were discharged from the ward. A safety follow-up visit was performed approximately 7 days after the last administration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Age 30-55 years
* BMI 18.0-29.9 kg/m²
* Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
68Ga-JH04 PET/CT in Patients With Various Types of Cancer

As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-JH04 is promising as an excellent imaging agent for various cancers. In this study, we observed the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As an emerging molecule targeting FAP, 68Ga-JH04, in this study, the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer were observed. Its imaging results were compared with those of 68Ga-FAPI or 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

Various solid tumors with available histopathological findings Signed informed consent

Exclusion Criteria:

pregnant or lactational women who suffered from severe hepatic and renal insufficiency