cyrilzakka/clinical-trials huggingface dataset:
Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old；
* Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
* Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography \[CT\] and/or endoscopic ultrasonography \[EUS\] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system；
* ECOG PS score: 0\~1；
* Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Exclusion Criteria:

* Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* patients who had previously received other treatments
* At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
* Those who already have esophageal perforation or are at high risk of esophageal perforation
* Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the
* there are active infections, such as active tuberculosis and hepatitis
* There are contraindications to immunotherapy.
* Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures
* Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes.
* Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.
Reuse of Intermittent Urethral Catheters

The purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization. The study will collect re-used catheters from included patients and compare those to a control group with regard to bacterial contamination and mechanical properties. A four week prospective evaluation will follow where the patients will be given catheters intended for single-use.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Female and/or male aged 18 years and over
* Intermittent self-catheterization as primary bladder management method, defined as a normal catheterization frequency of at least 4 times daily
* Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter
* Accustomed intermittent catheterization user, defined as intermittent catheterization use for at least 3 months
* Able to use catheters of size:

  40 cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;

Exclusion Criteria:

* Antibiotic treatment within 4 weeks prior study inclusion
* Drug or alcohol abuse or other disease of addiction
* Immunocompromising diseases or medications
* Known urological/renal anatomical abnormalities with potential impact on subject´s compliance as judged by the investigator
* Diagnosis of severe fecal incontinence that may compromise study participation as judged by the investigator
* Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
* Previous enrollment in the present study
* Simultaneous participation in another clinical study that may interfere with the present study, as judged by the investigator
* Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
The Reducing Risk Study

The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* any current psychiatric illness
* currently use of medications or herbs with known effects on sleep
* hospitalization for substance use or suicide within the past 12 months
* known sleep apnea
* unstable major medical conditions
* current psychotherapy for depression, anxiety or sleep health deficits
Role of Uromodulin in Management of Multiple Myloma

• To Evaluate the role of uromodulin level in early diagnosis of cast nephropathy and to detect its prognostic value in multiple myeloma patients

Multiple myeloma (MM) is a malignant plasma cell disorder . It is the second most common hematologic malignancy worldwide . It accounts for 15%-20% of all hematologic malignancies and has a 5-year survival rate of 60% .

About 31% of newly diagnosed MM patients presented with renal impairment and about 6% to 13% need dialysis , which significantly increases morbidity and mortality, and limits treatment strategies . Most common renal disease in MM is myeloma cast nephropathy that derived from secreted free light chains that combined with uromodulin to form cast which obstructs the distal tubules and presented with severe acute kidney injury . Renal biopsy is the only method to accurately diagnose myeloma cast nephropathy.

Uromodulin, also known as Tamm-Horsfall protein, is a kidney specific glycoprotein which is produced only by the epithelial cells lining the thick ascending limb (85%-90%) and early distal convoluted tubule (10%-15%), and is released to urine and blood . About 200 mg/day of uromodulin is normally excreted in urine . Recently, uromodulin being involved in many pathological processes as hypertension, urinary tract infections, nephrolithiasis, chronic and acute kidney disease.

Limited is known about role of uromodulin in management of myeloma. Measurement of serum uromodulin in patients that newly diagnosed multiple myeloma with and without renal impairment and follow up these patients for 1 year may provide a useful non-invasive predictor of cast nephropathy and may has a prognostic value in myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old that newly diagnosed with multiple myeloma according to 2024 updates in diagnosis of multiple myeloma (10) with and without renal impairment at nephrology and haematology unit of internal medicine department.

Exclusion Criteria:

* any patient have evidence of renal impairment due to any cause other than multiple myeloma as diabetic nephropathy, hypertensive nephropathy or lupus nephritis ... etc.
Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.

This is a randomized (to each eye, within patient), double-blinded, placebo-controlled study of the efficacy of Processed Amniotic Fluid (pAF) in patients with hematologic malignancies who have undergone Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and are diagnosed with Chronic Graft Verses Host Disease of the eye.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed within 5 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the following symptoms:

  1. Dry eye symptoms partially affecting (requiring lubricant drops \> 3 x per day or punctal plugs, or thermally cauterized puncta) or significantly affecting (special eyeware to relieve pain) activities of daily living (ADL)
  2. Unable to work because of ocular symptoms
  3. Loss of vision due to keratoconjunctivitis sicca (KCS)
* Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
* Patients who are 18 years of age or older.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Patients who have any other reversible cause for dry eye at the time of accrual.
* More than 3 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
* Relapsed malignancy at time of accrual after the most recent transplantation
* A difference in dryness between both eyes of more than 2 points of the grading provided by the International Dry Eye Workshop (DEWS) 2007 report
* Patients who are pregnant or plan to become pregnant while participating in the study.
* Patients who are not willing to discontinue the use of any eye drops, with the exception of non-medicated lubricant eye drops (artificial tears). All eye drops (excluding non-medicated lubricant eye drops) must be stopped at least seven days before treatment with pAF.
* Inability to comply with the investigational plan and visit schedule for any reason, in the judgement of the investigator.
Dental Implants and Mouth Rinse

The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or saline solution on bacterial contamination in the buccal vestibule when used preoperatively using the real-time Polymerase Chain Reaction (qPCR).

We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in greater reduction of bacterial counts than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.

The secondary aim of this study is to evaluate the effect of the tested mouthwashes in reducing the bacterial counts over time.

We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in a reduction of bacterial counts for longer duration than with essential oil-based, cetylpyridinium chloride, or saline mouthwashes.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is treatment planned for dental implant placement and qualifies for dental implant placement according to the standards of care in the Department of Periodontology at Tufts University School of Dental Medicine.
* Aged 18 years and above.
* Partially edentulous.

Exclusion Criteria:

* Antibiotic therapy within 2 weeks of the study.
* Active infection in the oral cavity.
* Known allergy to any of the agents used in the study.
* Self-reported pregnancy (as the surgical procedure of dental implant placement is elective and typically deferred until after the delivery).
* Fully edentulous.
* Patient with severe periodontitis (Clinical attachment loss of 5mm or more in the majority of intraoral sites).
* Regular use of mouthwashes (once/day).
Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery

The establishment of the Enhanced Recovery After Cesarean protocols resulted in to the production of specific care pathways with the aim of optimizing recovery after cesarean delivery (CD) and to reduce the costs to the health care system. Carbohydrate rich fluids are offered in this aspect to enhance postoperative quality of recovery. The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on obstetric quality of recovery after elective cesarean section.

The 10-item Obstetric Quality-of-Recovery scale is a validated patient-reported outcome questionnaire that evaluates recovery quality after delivery. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. The shortened pre-operative fasting period, in addition to the positive metabolic effects, enhance the post-operative recovery and shorten the hospital stay. Postoperatively, it is also crucial for the mother to heal rapidly and be able to care for her child on her own. Although a lot of effects of the preoperative carbohydrate loading has been studied yet, the OQR-10 scale and after carbohydrate loading has not been investigated yet.

All mothers undergoing a planned CD in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive carbohydrate solution ( Carb Group) and the other will consume same amount of placebo fluid (Noncarb Group).

The aim of this study is to determine the effect of carbonhydrate rich solutions on quality of recovery of parturients undergoing elective CD with Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years old and over
* Term singleton pregnancy
* Undergoing planned caesarean delivery at Karaman Training and Research Hospital
* Patients who have given informed written consent

Exclusion Criteria:

* Patients who have refused, are unable to give or have withdrawn consent
* Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater
* Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse
* Patients who have refused spinal anesthesia, or those in whom it is contraindicated.
* Pregnancy with preeclampsia or eclampsia
* Pregnancy with gestational diabetes mellitus or diabetes mellitus
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a first-time recipient of a kidney transplant from a deceased donor.
* Specific donor criteria

Exclusion Criteria:

* Donor age \<10 years
* Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
* Subjects with a positive T-cell lymphocytotoxic crossmatch.
* Subjects who are positive for Hepatitis B or C, or HIV
* Active tuberculosis
* History of cancer in the last 5 years
* History of substance abuse
* Specific laboratory results are exclusionary
* Mammography suspicious for cancer
* Allergy to iodine
* For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)

Study OpCT-001-101 is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in up to approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 will focus on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.

Phase 1 will include 4 planned dose levels to be administered across 4 cohorts (Cohorts 1 through 4). Participants will be assigned to receive OpCT-001.

Dose escalation in Phase 1 will be conducted using a standard 3+3 scheme in which a total of 12 to 24 legally blind participants (\~3 to 6 per cohort) will receive OpCT-001. Phase 2 is planned to enroll a maximum of 15 participants per cohort in 2 cohorts (Cohorts 5 and 6) to evaluate 2 dose levels of OpCT-001 that will be selected based on Phase 1 safety and tolerability data. Phase 2 participants will be randomized 1:1 to either Cohort 5 or Cohort 6. Phase 2 participants and the investigator/study site personnel outside of the surgical team will be masked to OpCT-001 dose assignments.

Eligibility Criteria:
Key Inclusion Criteria:

* Genetically confirmed diagnosis of primary photoreceptor (PR) disease
* BCVA at Screening for Phase 1: LogMAR 3.9 to LogMAR 1.0. BCVA at Screening for Phase 2: ETDRS letter score 20 and 60.
* Retinal structure examination in the study eye (SE) demonstrating regions suitable for cell administration.

Key Exclusion Criteria:

* History of/currently active clinically relevant, ocular inflammation or infection
* Glaucoma or other significant optic neuropathy
* Diabetic macular edema or diabetic retinopathy
* Clinically significant cystoid macular edema
* Spherical equivalent refractive error of greater than 8.00 diopters myopia
* Ocular surgery ≤3 months before Screening
* Monocular vision (ie, no light perception in the fellow eye)
* Presence of clinically significant anti-OpCT-001 HLA antibodies at Screening
* Currently active malignancy, or history of malignancy within 5 years before OpCT-001 administration. Exception: Basal cell carcinoma that has been definitively treated.
* Any current infection (bacterial/viral/fungal) that could put the participant at risk from immunosuppression
* History of any cell therapy, gene therapy, or retinal implant at any time
* Previously received a bone marrow or solid organ transplant
3D Printing Guides in Total Knee Arthroplasty

This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.

Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;
* Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;
* The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.

Exclusion Criteria:

* Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;
* Patients with traumatic arthritis and inflammatory arthritis;
* Patients with huge bone defects around the knee
* Patients who had active infection around the knee;
* Patients with knee valgus deformity;
* Patients with severe extra-articular deformity;
* Patients who had previous knee surgery;
* Patients who had periarticular soft tissue dysfunction and neuropathy;
* Patients who had poor physical condition and could not withstand the operation;
* Patients who refused to be followed.
Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women

Pregnancy is associated with an increase in nutrient requirements. During this period, women would be keener on adopting healthier behaviors. Thus, pregnancy represents an opportunity to improve the nutrient adequacy of the diet of mothers-to-be. This study is a randomized controlled trial, which aims at evaluating the efficiency of a tailored dietary advice tool in improving the nutrient adequacy of the diet of pregnant women, as measured by the PANDiet. Eighty pregnant women will be included in the study and randomized either in the "control" group, or in the "intervention" group. The control group will receive generic dietary advice based on a booklet edited by the French Institute for Health Promotion and Health Education (INPES). The intervention group will receive the same generic dietary advice plus tailored dietary advice to improve the nutrient adequacy of their observed diets. Dietary intakes will be evaluated online using a 3 days food record, at baseline and 6 weeks after patients received the booklet and/or the first tailored dietary advice. Thus, the nutrient adequacy of the diet could be evaluated before and after the intervention in both groups.

The dietary follow-up for one patient will last 12 weeks only, but data will be collected at delivery.

"Moreover, after, the 12-week dietary follow-up and before their deliveries, 10 participants (5 by group) will be contacted to participate in a qualitative interview. This interview will aim at understanding barriers and motivators to implement dietary advice (generic and/or tailored) in the diet of pregnant women in the study.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Pregnant (between 10 and 24 amenorrhea weeks)
* Aged from 18 to 40
* BMI between 18.5 and 25 kg/m²
* Singleton pregnancy
* Fluently speaking, writing and reading of French
* Having a daily internet access, a personal email address and phone number
* Benefiting from the French Health Coverage
* Not suffering from a gestational diabetes during this pregnancy or a previous pregnancy
* Not being on a specific diet for medical purpose
* Not suffering from major food allergies

Exclusion Criteria:

* Diagnosis of a gestational diabetes during the 12 weeks of the study
* Diagnosis of a pathology that would require diet modifications during the 12 weeks of the study.
* Abortion