cyrilzakka/clinical-trials huggingface dataset:
A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in perioperative treatment of muscle-invasive bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 12 weeks.
* Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC) .Naive of antitumor systematic treatment or radiotherapy.
* Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by imaging.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

* Has received other antitumor therapy before planned start of trial treatment.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
* Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
* NYHA Class III heart failure.
* Suffering from active infection requiring systemic treatment.
* Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
* Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Pregnancy or lactation.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Latent Tuberculosis Infection in Renal Transplant Recipients

The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.

We evaluate the usefulness of a newly-developed T cell-based assay prior to undergoing immunosuppression in renal transplant recipients. Among all renal transplant recipients, patients with negative tuberculin skin test and no other indications for latent tuberculosis infection will be enrolled in this study. We will exam T-SPOT.TB test in these patients, and observe the developement of tuberculosis within 1 to 2 years after the transplantation. The results of T-SPOT.TB will be blinded to the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 or more
* Negative tuberculin skin test (induration less than 10 mm)

Exclusion Criteria:

* Recent contact of patients with active pulmonary tuberculosis
* Suspected active tuberculosis
Functional Magnetic Resonance Imaging in Infants

The study proposes to evaluate cognitive development in infants four months or younger by functional MRI and event related potential recording. fMRI imaging will be obtained following an auditory stimulus inside the 4 tesla magnet at the Center for Magnetic Resonance Research and will be correlated with ERP response to the same stimulus.


Eligibility Criteria:
Male or female infants less than 4 months old
Ultrasound Prescan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients

The study is aimed at evaluating whether ultrasound pre-procedural scan with Accuro may reduce needle redirections when performing spinal injection in patients with BMI = or \> 30 in orthopedic surgery

This is a open-label randomised controlled study.

90 patients will be recruited and divided into two groups of 45 patients per group.

Patient recruitment will be performed by patient visit and checking inclusions and exclusion criteria. After written informed consent, every single patient will be allocated in one of the two groups following a computer generated randomization list.

Patients in both groups will undergo:

* standard monitoring with Non Invasive Blood Pressure (NIBP) cuff, three-lead electrocardiography (ECG) and Pulse-oximetry (SpO2).
* Peripheral intravenous access
* Sedation (as prescribed by the OR anesthesiologist)
* Spinal anesthesia performed by anesthesiologists skilled in both techniques (conventional landmark technique or Accuro guided) at the L3-L4, L4-L5 or L5-S1 level, with a 25 or 27 Gauge needle, with the surgical side declive or proclive according to the baricity of the local anesthetic used (sitting position, when needed, will be reported in the CRF)

In both groups an observer will monitor and register spinal procedure duration (starting point: anesthesiologist wearing sterile gloves, ending point: end of local anesthetic injection).

Control group (landmark technique):

The anesthesiologist will identify lumbar spinous processes with traditional landmark palpation. Once the correct interspinous level and the mid-line will be identified, the anesthesiologist will proceed with needle insertion and spinal injection.

Treatment group (ultrasound pre-procedural scan with Accuro):

By using Accuro US probe the anesthesiologist will perform a pre-procedural lumbar spine scan to detect the needle entry site. After image optimization, the Accuro probe will be aligned with the spine mid-line, as indicated by a dashed red-line on the screen. After that the interlaminar space at the desired intervertebral level will be detected, as indicated by orange overlay in the screen. The depth and the device angle used to detect the interlaminar space will be annotated. The anesthesiologist will then disengage the Accuro Locator needle guide and press gently against the skin. Then the probe will be removed and the spinal injection will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* BMI ≥ 30 kg/m2
* American Society of Anesthesiologists' (ASA) classification I-III
* Orthopedic surgery to be performed under spinal anesthesia
* Able to understand and to sign informed consent

Exclusion Criteria:

* Local anaesthetic allergy
* Serious spine deformities
* Previous spine surgery
* Inability to express informed consent
* Contraindications to spinal anaesthesia
* Pregnancy
Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy

This is a Phase 1, open-label, dose escalation study aimed at evaluating the safety, early efficacy and potential biomarkers of (+)-epicatechin in patients with Becker or Becker-like Muscular Dystrophy (BMD).

The safety and tolerability of three escalating doses of (+)-epicatechin will be assessed and early effectiveness measured by changes in plasma biomarkers, tissue biomarkers from muscle biopsies, cardiac imaging, and on clinical function assessments of participants' muscle strength. All patients will receive oral (+)-epicatechin for a total duration of approximately 52 weeks. Three doses of (+)-epicatechin will be tested in sequential 2 month periods with total daily doses of 75, 150, and 225 mg/day (+)-epicatechin. Doses will be escalated every 2 months, if tolerated, for the first 6 months of the study. Participants will then continue to receive the highest does they tolerated for an additional 6 months.

Eligibility Criteria:
INCLUSION CRITERIA:

1. Participant must be ≥16 to \<60 years of age.
2. Genotype confirmation showing a mutation of the dystrophin gene.
3. Ambulation - participants must show a history of ambulation past the age of 16 years, with continued ambulation thereafter.
4. If on glucocorticoid treatment in the last 12 months, participants must be on a stable dose at screening. Participants cannot start steroids during the study.

EXCLUSION CRITERIA:

1. A diagnosis of other neurological diseases or presence of relevant somatic disorders that are not related to Becker muscular dystrophy.
2. Participants with a history of migraine headaches requiring medical attention and active treatment within the past 6 months.
3. Participants with allergies to chocolate or cocoa.
4. Surgery or orthopedic injury that might affect muscle strength or function within 3 months before study entry or planned surgery at any time during the study.
5. Presence of a concomitant neurologic disease (e.g., Parkinson's disease) that could negatively impact mobility or balance.
6. Symptomatic heart failure (New York Heart Association Class III or IV) or known left ventricular ejection fraction \<40% by echocardiogram.
7. Presence of documented intrinsic lung disease (e.g., chronic obstructive pulmonary disease, pulmonary fibrosis).
8. Evidence of current liver disease or impairment.
9. Inadequate renal function.
10. Platelet count, WBC count, and hemoglobin at Screening \<Lower Limit of Normal (LLN).
11. Surgery or orthopedic injury that might affect muscle strength or function within 3 months before study entry or planned surgery at any time during the study
The Role of Bleeding at Implant Placement

Angiogenesis is inherently associated to bone formation and healing. During implant osseointegration, a successive and successful angiogenic processes has to occur to promote bone formation. In 1969, Branemark et al. demonstrated that direct contact between bone and titanium implant surface was possible, defining osseointegration as "the direct, structural, and functional contact between live bone and the surface of a functionally loaded implant". Consequently, the need of an empirical measurement appeared. With the introduction of resonance frequency analysis (RFA), it is now possible to measure the degree of implant stability at any time during the course of implant treatment and loading. In this way, changes in implant stability can be monitored over the time and it is likely possible to find implants at risk of failure before they become loose. The rationale of this study is to analyse how important a good vascularization is for the future bone formation around dental implants.


Eligibility Criteria:
Inclusion Criteria:

* Males or females American Society of Anesthesiologists classification (ASA) I or II, between 18 to 80 years of age
* Patient in good general health as documented by self-assessment.
* Patients needing implant rehabilitation in the upper or lower jaw.
* Patients must be committed to the study and must be willing to sign the informed consent.

Exclusion Criteria:

* Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
* Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
* Current pregnancy or breast feeding/ lactating at the time of recruitment.
* Radiotherapy or Chemotherapy in head and neck area.
* Intravenous and oral bisphosphonate therapy.
* Patients smoking \>20 cigarettes a day.
* Unwillingness to return for the follow-up examination.
* Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations.

Local exclusion criteria:

* Immediate implant placement after tooth extraction.
* Risk of extra bleeding due to inflammatory or infectious processes near the zone of implantation.
The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes Towards Sexuality and Sexual Distress in Pregnant Women

The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women

Purpose of the study: In the light of these data, the effect of sexual health education based on the PLISSIT model on sexual function, attitude towards sexuality and sexual distress in nulliparous pregnant women will be examined in a randomized controlled experimental study. It is thought that the data to be obtained will shed light on sexual health education and counseling practices for midwives working with pregnant women in their application areas.

The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women

Method of the study: FSFI will be applied to pregnant women between 14-20 weeks of gestation who apply to Trakya University Health Research and Application Center Obstetrics Clinic, Polyclinic and Perinatology Clinic departments, and women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction. Pregnant women will be randomized according to the last digit of their protocol number. Pregnant women divided into control and intervention groups will be given PLISSIT model-based sexual health education to the intervention group and a clinical procedure will be applied to the control group. The Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered simultaneously. Four weeks after the training, the FSFI application and the Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered again.

Eligibility Criteria:
inclusion criteria: Volunteer to participate, 19 years of age and over, sexually active, at least primary school graduate, of Turkish origin, no communication problems, 14th-20th age, fluent in Turkish. Pregnant women in their 2nd week will be included in the study.

exclusion criteria: Pregnant women who are at serious risk during pregnancy, who are diagnosed with sexual dysfunction, who have mental problems that require treatment, and who use drugs that cause sexual dysfunction will not be included in the study Pregnant women who leave their information forms unfinished, experience loss, and want to leave the study will be excluded.

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Open-Label Surufatinib in European Patients with NET

This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low to intermediate grade (Grade 1 or Grade 2), well-differentiated neuroendocrine tumours (NETs).

This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low- to intermediate-grade (Grade 1 or Grade 2), well-differentiated NETs.

The study will enroll 4 cohorts of varying NETs, as follows:

* Cohort A - NET of lung origin
* Cohort B - NET of small bowel origin
* Cohort C - NET of non-small bowel, non-pancreas, and non-lung origin
* Cohort D - NET of any origin (DDI substudy)

All patients will be treated with oral surufatinib 300 mg QD in treatment cycles of 28 days starting on Cycle 1 Day 1.

Eligibility Criteria:
Key Inclusion Criteria:

1. Has histologically or cytologically documented, locally advanced, or metastatic NET and has progressed on at least 1 prior line of therapy, but no more than 3 therapies;
2. Has radiologic evidence of progressive tumour within 12 months of study enrolment
3. Is willing and able to provide informed consent
4. Is ≥18 years of age
5. Has measurable lesions according to RECIST Version 1.1
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception

Key Exclusion Criteria:

1. Has an AE due to previous anti-tumour therapy that has not recovered to ≤CTCAE Grade 1, except alopecia and peripheral neurotoxicity with ≤CTCAE Grade 2 caused by platinum chemotherapy
2. Major surgery within previous 4 weeks or radiation therapy within 2 weeks prior to the start of treatment.
3. Prior VEGF/VEGFR-targeted therapy
4. Uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication
5. Gastrointestinal disease or condition within 6 months prior to first dose
6. Has a history or presence of a serious haemorrhage (\>30 mL within 3 months) or haemoptysis (\>5 mL blood within 4 weeks) within 6 months of first dose of study drug.
7. Clinically significant cardiovascular disease.
8. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease (SD) for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded.
9. A high risk of bleeding at screening due to tumour invasion into major vessels, such as pulmonary artery, the superior vena cava, or the inferior vena cava, as determined by investigators.
10. Has arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events (including stroke and/or transient ischaemic attack) within 12 months.
11. Has a clinically meaningful ongoing infection (eg, requiring intravenous treatment with anti-infective therapy)
Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with allergy or drug hypersensitivity
* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.

To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.


Eligibility Criteria:
Physician inclusion criteria:

* Oncologist or gynecologist.
* Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
* Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.

Patient inclusion criteria:

* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
* Received palbociclib as a first line therapy.
* No prior or current enrolment in an interventional clinical trial for ABC/MBC.
* Minimum of six months of follow up data since palbociclib initiation.

Physician exclusion criteria:

* Qualified less than 2 years ago or more than 35 years ago.
* Participated in observational research for ABC/MBC in the last 3 months.
* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.
Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder

A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.

Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety Disorder. Participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.

Eligibility Criteria:
Inclusion Criteria:

* Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
* Comorbidity is allowed, but social phobia must be the primary diagnosis.

Exclusion Criteria:

* Below 18 years old.
* Individuals who are suicide prone will be excluded from the study.
The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

It is aimed to compare the effect of two different splints on carpal tunnel syndrome in pregnant individuals after 4 weeks of use.

Carpal tunnel syndrome (CTS) is a common musculoskeletal problem in pregnancy. The aim of this study is to compare the effects of rigid and elastic wrist splints on edema, pain levels, grip strength, and upper extremity functionality in pregnant women with CTS.

Pregnant women in the last trimester of pregnancy who were diagnosed with CTS were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Being in the last trimester of pregnancy,
* Having a diagnosis of CTS,
* Positive Tinnel and Phalen tests,
* Pain, tenderness, and numbness symptoms in the median nerve neurodynamic test,
* pain of at least 4 severity according to VAS,
* Edema due to pregnancy

Exclusion Criteria:

* Individuals in the 1st or 2nd trimester of pregnancy,
* Those with pain complaints below 4 according to VAS,
* Those with a history of CTS before pregnancy,
* Those who had undergone surgery in the hand-wrist region
* Those diagnosed with cervical disc herniation
PRT Versus CBT on Chronic Non Specific LBP

The goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain.

The main question aims to answer :Is there any differences of using positional release techniques versus cognitive behavioral therapy on patients with chronic low back pain?

Design of the study :

Pretest-posttest randomized controlled trial.

Subjects selection :

sixty patients their age between 25-45 years of both genders with chronic non specific low back pain will participate in this study according tosample size calculation.

Eligibility Criteria:
Inclusion Criteria:

* All patients will be clinically diagnosed with chronic non specific low back pain .
* Their ages will range from 20to40years old.
* body mass index will range from 18 to 30 kg/cm².
* Cognitive score will be 23 or above .
* Voluntary acceptance of participation in this study.

Exclusion Criteria:

* Lumbar canal stenosis
* Lumbar discogenic lesions
* Lumbar infections,tumors.arthiritis
* Patients with decreased range of motion due to congenital anamolies.
* Cognitive and emotional disturbances
High Dose Nimodipine Treatment Adjunct - 1

The purpose of this study is to determine if nimodipine is more effective than placebo in reducing stimulated craving for cocaine in cocaine dependent individuals denied access to cocaine in inpatient unit.


Eligibility Criteria:
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