cyrilzakka/clinical-trials huggingface dataset:
A Study of TJ003234 in Rheumatoid Arthritis Patients

Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
* Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
* Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and \>3.2.
* Allowed one or more standard treatments, but the start date should no later than 12 weeks(84 days) before the randomisation and should take at a stable dose more than 4 weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX) and leflunomide was not allowed within 4 weeks (28 days) before randomization.
* Subjects must agree to attendance the study and signed the inform concent by themselves.
* Subjects(include subjects's wife) are no pregnancy plan during the sceering and 3 months after complete the study and agree to use contraceptives that protocol suggest.

Exclusion Criteria:

* Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
* A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
* Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection.
* A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
* Female patients who are pregnant during the study, or are breastfeeding. •Malignancy, or prior malignancy, with a disease free interval of \<5 years after diagnosis and intervention except curative treatment for basal and squamous cell skin cancer.
Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon learn more about the relationship between bone mineral density (BMD) and a special vessel subtype (type H vessel).

PURPOSE: This research study is looking at changes of a special vessel subtype in bone samples from patients with osteoporotic and nonosteoporotic fracture.

OBJECTIVES:

1. Establish type H vessel in bone specimen in patients with hip fracture.
2. Explore the correlation of BMD and type H vessel.

OUTLINE:

1. Collect human bone specimens from patients with Osteoporotic and Nonosteoporotic Fracture.
2. Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators.
3. Observe the type H vessel in bone slice by immunofluorescence staining.
4. Collect clinical data on these patients including bone mineral density.
5. Investigate the relationship between BMD and type H vessel.

Eligibility Criteria:
Inclusion Criteria:

1. Ages Eligible for Study: 65-75 Years
2. Genders Eligible for Study: Woman
3. Accepts Healthy Volunteers: NO
4. Study Population: Female patients with hip fracture. -

Exclusion Criteria:

1. Malignancy or benign ovarian cysts
2. Known chronic or systemic diseases
3. Hormone therapy in the previous 3 months
4. Bone metabolism and drug therapy
Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis

The aim of this study is to investigate whether minimally invasive thymectomy achieves comparable efficacy and safety results compared to open thymectomy in patients with myasthenia gravis. The planned investigation is a multicenter observational study based on retrospective (present patient data) and prospective data (questionable outcome data).

Primary hypothesis: Minimally invasive thymectomy is not inferior to open thymectomy in terms of efficacy and safety (non-inferiority study).

Based on large cohort studies of the last decades, the thymectomy has become a central component of the immunomodulating therapy in MG patients without thymoma detection. Because randomized studies were missing, remained a residual uncertainty on the importance of Thymectomy. In the study "Randomized Trial of Thymectomy in Myasthenia Gravis" (MGTX-study) published 2016 the effectiveness of thymectomy by patients without thymoma detection has been indisputable confirmed. A significant improvement of the patient's complaints and the reduction of the immunosuppressive drugs were particularly evident by early onset MG (EOMG) two to three years after performing a complete resection of the thymic tissue.

While the MGTX study (with an open operative procedure) was being done, the minimally-invasive thymectomy has gained more and more acceptance. From a surgical point of view, the minimally invasive thoracoscopic procedure represents a gentler alternative. According to the momentaneous clinical-scientific point of view, further studies are necessary to compare both procedures. Furthermore, the MGTX study included only patients with generalized MG and positive anti-Acetylcholine Receptor (AChR)-antibodies, who were younger than 65 years, so that the relevance of thymectomy in other important subgroups, such as late onset MG (LOMG), the ocular MG (OMG), as well as the patients without detected antibodies (seronegative MG patients), who represent about 10 % of whole population of MG patients, is still not clear.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Myasthenia Gravis
* Age ≥18 years

Exclusion Criteria:

* a proper communication with the patient is not possible
* an informed consent could not be signed
* a patient reject a participation or requires breaking up
Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery

High positive end-expiratory pressure (PEEP) levels required to achieve clinical benefits may increase ICP and reduce cerebral perfusion pressure (CPP) in patients at risk of intracranial hypertension.

However, individualizing ventilation parameters is essential for each patient. Among protective ventilation strategies, PEEP is key to preventing alveolar collapse. The PEEP level that minimizes alveolar collapse while avoiding overdistension of the pulmonary parenchyma is known as the Best PEEP. This study aims to evaluate the application of Best PEEP in cranial neurosurgery.

In general anesthesia for neurosurgery, mechanical ventilation is the standard approach. However, mechanical ventilation can induce pulmonary parenchymal injury through various mechanisms, including volutrauma, barotrauma, and atelectrauma. These correspond to lung damage caused by high tidal volumes, elevated airway pressures, repetitive alveolar collapse, and reopening. Protective ventilation strategies include limiting tidal volume (Vt), applying positive end-expiratory pressure (PEEP), and performing alveolar recruitment maneuvers (ARM).

Historically, both ARM and higher levels of PEEP have been avoided in neurocritical patients, including those undergoing neurosurgery, due to concerns about their potential impact on intracranial pressure (ICP) and cerebral perfusion pressure (CPP). As postoperative pulmonary complications can significantly alter the prognosis of surgical patients, increasing hospital stay and healthcare costs, and, in neurocritical patients, compromising cerebral oxygenation, protective ventilation strategies may play a critical role in patients undergoing neurosurgery. Their historical exclusion from studies lacks demonstrated physiological justification.

Here, the investigators aim to evaluate the impact of intrathoracic pressure on ICP in neurosurgical patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I-III.
* Elective cranial neurosurgery.

Exclusion Criteria:

* ASA classification IV or higher.
* Documented intracranial hypertension.
* Severe pulmonary disease (e.g., asthma, COPD).
* Emergency surgery.
Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists

The main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. The secondary objectives are the description of social demographic profiles, the personal and family histories,psychiatric co-morbidities, the side effects of androgen antagonists treatment. This study, the first of its kind in France, may allow to better understand the social demographic and clinical profile of sexual offenders with paraphilias treated with androgen antagonists.

To be included, the subject must have committed a sexual offense and must present a diagnosis of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized by "sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner, (3) children or other persons without their consent, occurring during a period of at least six months "(Criterion A). This disorder is responsible for sexual behavior which is "clinically significant disturbances in social, occupational or other important areas of functioning" (Criterion B).

The inclusion of approximately 200 subjects is expected in this study. The inclusion period will last for 12 months.

Data will be codified and only a few investigators will have access to these data. The statistical analyse will use the usual descriptive parameters: mean, standard deviation, median, interquartile range and range for quantitative variables, frequencies and cumulative frequencies (if applicable) for qualitative variables.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of paraphilia based on DSM-IV-TR
* antecedent of sexual offence

Exclusion Criteria:

* no diagnostic of paraphilia
Novel Meal Service Improves Nutritional Intake

This study aims to investigate whether a novel meal service FoodforCare (FfC), comprising 6-protein-rich meals a day following proactive advice from a nutritional assistant, improves dietary intake and patient satisfaction, compared to the traditional 3-meals a day service (TMS).

The investigators performed a quasi experimental study at medical (Gastroenterology) and surgical (Gynecology, Urology, Orthopedics) wards. Patients were offered TMS (July 2015 - May 2016; n=326) or FfC meal service (after stepwise introduction per ward from January 2016 - December 2016; n=311). Primary outcome was the mean percentage of protein and energy intake relative to requirements, between patients receiving TMS and those receiving FfC, on the first and fourth day of full oral intake. Patient satisfaction comprised rating of the experienced quality of the food and the meal service and by means of a validated questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking
* Aged 18 years or older
* Exclusively oral intake
* Expected hospital stay of at least 1 day

Exclusion Criteria:

* Patients with tube- or parenteral feeding
* A language barrier
* Considered to be too weak to adequately answer our questions
Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®

Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.


Eligibility Criteria:
Inclusion Criteria:

* Has given written informed consent to entry
* Female, 22 years to 60 years
* Breast augmentation(cosmetic surgery) is for following subjects

  * Who is not content with breast size and shape
  * Who has congenital asymmetrical deformity
* subject who agree to MRI scan during the trial
* subject who agree to visit to hospital according to schedule specified in the protocol during the entire period of the trial

Exclusion Criteria:

* Pregnant or lactating women and women of childbearing age
* Subject who has operation history of breast augmentation or reconstruction
* Subject who has fibrocystic Breast Disease coming up for precancerous lesion not accompanied with subcutaneous mastectomy
* Subject who has breast cancer or prodromal phase and no proper treatment.
* Subject who is diagnosed with Breast Imaging-Reporting and Data System(BI-RADS) category 3 under breast ultrasonography.
* Subject who has uncontrolled active infectious disease or abscess
* Autoimmune disease
* Diabetes mellitus
* Keloidosis
* Subject who cannot take general anesthesia due to abnormal blood or ECG results.
* Subject who is not appropriate for breast augmentation due to damaged tissue or blood vessel or ulcer
* Subject who has metal materials in a body such as ventricular assist system or cerebral aneurysm clips, or has claustrophobia (not suitable for MRI SCAN)
* Physically/mentally disabled subject that may disturb understanding and cooperation for the trial.
* Any other conditions that may interfere with correct assessment of the trial.
Acute Hemodynamic Changes During Paracentesis

The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing.


Eligibility Criteria:
Inclusion Criteria:

* refractory tense ascites with indication for therapeutic paracentesis

Exclusion Criteria:

* pregnancy
* inability to give inform consent
* inability to perform rebreathing maneuver
Mineral-Homeostasis in Continuous Renal Replacement Therapy

Acute renal failure is a common complication in intensive care unit patients. In 10% of cases renal replacement therapy becomes necessary. Current devices have increase filter patency and efficacy. However, magnesium, calcium and phosphate are eliminated as well. However, the extend of this elimination hase not been quantified. Thus, we want to

1. record retrospectively how often abnormal values for phosphate, magnesium and calcium occurred during routine renal replacement therapy in 2011 and 2012.
2. prospectively evaluate the same parameters during routine treatment in 2013 and 2014


Eligibility Criteria:
Inclusion Criteria:

* intensive care unit patients with acute renal failure undergoing continuous renal replacement therapy
* older than 18 years of age

Exclusion Criteria:

* age less than 18 years
* pregnancy
* contraindications against continuous renal replacement therapy
Cardiox Shunt Detection Technology Study

The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against transesophageal echocardiography (TEE) for sensitivity and specificity, as well as transcranial doppler (TCD) for positive percent agreement and negative percent agreement.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen (18) years of age or older
* Informed consent documentation understood and signed
* Planned or completed TEE study within the last 12 months

Exclusion Criteria:

* Subjects with a known allergy or sensitivity to Indocyanine Green Dye (ICG) or to Iodide Contrast Dye or Iodides
* Pregnant women or nursing mothers
* Subject unable or unwilling to understand and sign the informed consent
* Subject scheduled for radioactive iodine uptake test (Thyroid test) within 7 days of post screening
* Subjects that have poor renal function such as subjects on dialysis, subjects with a recent history of creatinine \> 2.0 or subjects currently being followed by a nephrologist
Entre Herman@s: Promoting Health Among Latino MSM

This is a randomized controlled trial with an attention placebo control group. The goal of this study is to decrease HIV incidence in Latino men who have sex with men by engaging their siblings in PrEP-use promotion. In the intervention arm, siblings will be trained to engage their gay brother in PrEP conversations. In the control arm, siblings will be trained to engage their gay brother in conversations about vaccines to prevent COVID, Hepatitis A/B, or MPOX.


Eligibility Criteria:
Inclusion Criteria: Latino Men Who Have Sex with Men

1. self-identify as Latino
2. identify as male
3. be \<40 years old
4. report HIV-negative status
5. be willing to talk about MSM healthcare issues with a sibling
6. either (a) have never used PrEP or (b) stopped using PrEP at least 90 days ago
7. missing most recent COVID vaccine
8. missing Hepatitis (A or B) vaccines
9. missing Mpox vaccine
10. meet CDC's PrEP eligibility criteria (be HIV-negative; any male sex partner in the past six months; not in a monogamous partnership with a recently tested, HIV-negative man; and at least one of the following: any anal sex without condoms in past 6 months, any sexually-transmitted infection (STI) diagnosed or reported in past 6 months, or is in an ongoing sexual relationship with an HIV-positive male partner).

Exclusion Criteria: Latino Men Who Have Sex with Men

1. are unable to provide consent or
2. they do not meet any of the criteria above

Inclusion Criteria: Siblings

1. at least 18 years old
2. report a close relationship his/her LMSM brother \<40 years old
3. be willing to talk about MSM healthcare issues with his/her LMSM brother

Exclusion Criteria: Siblings

1. are unable to provide consent or
2. they do not meet any of the criteria above
Bringing What Works to Youth in Corrections: A Trauma Intervention

Youth with mental illnesses are disproportionately represented in juvenile correctional facilities and limited evidence exists about effective treatments in this setting. This study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be efficacious in community settings, to the correctional setting and study the feasibility of its implementation. Conducted within Texas youth correctional facilities, the findings will be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the unique needs of incarcerated youth and the correctional system, one of the priorities outlined in the National Institute of Mental Health Strategic Plan.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of one or more significant traumatic life events
* Current diagnosis of one of the following:

  * Post Traumatic Stress Disorder
  * Major Depressive Disorder
  * Dysthymia
  * Generalized Anxiety Disorder
  * Social Phobia
  * Panic Disorder
* Trauma symptom severity scores of 25 or greater.

Exclusion Criteria:

* Expected release date or transfer date within 5 months from study enrollment date
* Current inclusion in the Sex Offender Treatment Program
* Intellectual Quotient (IQ) less than 70
* Current high risk of suicidality
* Current symptoms of active psychosis
"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"

Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™)

Posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (CD HORIZON BalanC™ Manufacturer: Medtronic)

Control:

Posterior spondylodesis and monosegmental intervertebral cage

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Legal capacity
* Age ≥ 30 years
* Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III \[20\]\[21\]\[22\] or spondylolisthesis Meyerding grades I-III.
* Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability

Exclusion Criteria:

* Motor deficit
* Cauda equina syndrome
* Previous surgical intervention of the lumbar spine
* Relevant peripheral neuropathy
* Acute denervation subsequent to a radiculopathy
* Scoliosis with Cobb angle greater than 25°
* Spondylolisthesis \> Meyerding grade III
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)
* No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with \>Fujiwara grade II \[15\] or \>Pfirrmann grade IV \[14\]
* Signs of instability in any lumbar spine segment other than that undergoing fusion
* General contraindication for elective lumbar spine surgery
* Pathologic fracture
* Osteoporosis with pathologic fracture
* Active systemic infection
* Rheumatic disease
* Disease of bone metabolism (e.g. Paget's Disease)
* Bone metastasis
* Local infection focus lumbar spine
* Seizure disorder
* Chronic ischemia Fontaine classification IIb-IV
* Severe heart insufficiency (NYHA III-IV)
* Blood coagulation disorder or blood thinning therapy
* Cortisone intake more than one month in the last 12 months before randomization
* Simultaneous participation in another clinical trial in the 30 days before randomization
* Known allergy or intolerance to the implants
* Dependency on investigator
* Lack of familiarity with the German language
* Placement in an institution by governmental or juridical advice
* Absent legal capacity
* Pregnancy
Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora

Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.

Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level. 203 healthy cohorts were treated with azithromycin, clarithromycin, or a placebo in a randomised, double-blind trial. Pharyngeal swabs were collected pre- (day 0) and post-antibiotic administration (days 8, 14, 28, 42, 180) and proportions of macrolide-resistant streptococci (MRS) were determined at each time-point.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults (≥ 18 years of age)
* non-pregnant
* free of any respiratory tract infection
* not having been administered any antibiotic at least in the past three months

Exclusion Criteria:

* \<18 years of age
* pregnant
* having a respiratory tract infection
* having been administered any antibiotic at least in the past three months