cyrilzakka/clinical-trials huggingface dataset:
Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.

The aim of this Phase 2 study is to evaluate the efficacy and safety of nivolumab, an anti-PD-1 antibody, and ipilimumab, an anti-CTLA-4 antibody, in T1aN0M0 clear-cell RCC patients ineligible for surgical treatment.

Surgery remains the standard curative-intent therapy for localized renal cell carcinoma (RCC). Thus, systemic therapy for RCC should still be considered only in patients who have contraindications to surgery.

Results of Phase 3 CheckMate 214 study showed that a combination of nivolumab and ipilimumab has a significant impact on tumor burden in intermediate- and poor-risk metastatic RCC patients with a complete response rate of 11% (Motzer et al. Lancet Oncology 2019). Median time to objective response was 2.8 months. Among all complete responders to nivolumab plus ipilimumab in the intention-to-treat population, 5% achieved a complete response at the first scan, whereas most converted from the partial response at a median of 6.9 months or from the stable disease at a median of 11.3 months.

We hypothesize that this combination could completely eliminate primary tumors in patients with small primary (less than 4 cm) ineligible for surgical treatment. There are no studies evaluating checkpoint inhibitors in this setting in RCC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Cytologically proven clear-cell RCC
2. CT-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (T1aN0M0)
3. Inability to perform surgery for any reason (functional single kidney with a central, high-complexity RCC, high risk of nephrectomy and dialysis, patients with complex coagulation disorders, etc.) or preference of patient is to have no surgery for any reason
4. No contradictions to nivolumab and ipilimumab
5. Age 18 or older
6. Written informed consent

Exclusion Criteria:

1. prior treatment for RCC
2. pregnant or nursing
3. history of serious hypertension, cardiac arrhythmia, congestive heart failure, angina pectoris, or another severe cardiovascular disease (i.e., New York Heart Association class III or IV)
4. evidence of metastatic disease
5. local and/or systemic infections requiring antibiotics within 28 days prior to study entry
6. other malignancy
The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

Hypomagnesemia is common early after transplantation, especially in association with calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without diabetes but this was never evaluated in transplant recipients.

The aim of the study is to assess whether magnesium improves glycemic control and insulin sensitivity early after transplantation.

The study is an open label study in which adult hypomagnesemic renal transplant recipients are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no supplementation.

The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on glycemia and the development of diabetes after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplantation recipients
* \> 18 years of age
* Less than 2 weeks post-transplantation
* Hypomagnesemia \< 1,7 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter).

Exclusion Criteria:

* Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
* Serum creatinine \> 3 milligram/deciliter
* Active infection (C reactive protein \> 3 milligram/deciliter)
* Severe hypomagnesemia (\< 1,2 milligram/deciliter)
* Hypokalemia (\< 3,5 milli-equivalent/liter)
* Severe hypocalcemia (\< 6,5 milligram/deciliter)
A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.

The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.

Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.

Study Design: A prospective randomized controlled study


Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract patients
* Age from 65 to 90
* The diameter of pupil after mydriasis is more than 6 mm
* LOCS III nuclear grade ≥4
* Corneal endothelial cell count \> 1500 cells/mm2
* Phacoemulsification and intraocular lens implantation are planned
* Agree to participate in this study and sign informed consent

Exclusion Criteria:

* History of ocular trauma
* Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
* Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
* History of Ophthalmic Surgery
* Intraoperative and Postoperative Complications
Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control

Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.

Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.

One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ age ≤ 80 years old.
2. Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
3. 8% ≤ HbA1c ≤ 12% in the last 1 month.
4. Insulin therapy within 1 month of planned discharge from hospital.
5. Frequency of self-monitoring of blood glucose \<4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation.
6. Willing and able to provide written informed consent and comply with the requirements of this study.

Exclusion Criteria:

1. Oral steroid hormone therapy.
2. Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
3. Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
4. Patients with severe kidney injury or end-stage renal disease (eGFR \< 30 mL/min/1.73 m2).
5. Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
7. Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer

To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment

Condition: Ovarian Cancer, Second line, Third line, or Fourth line

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria

* Ovarian cancer that is not refractory or resistant to platinum-based therapy (refactory=progression while receiving any previous platinum regimen; resistant=progression within 6 months of any previous platinum regimen)
* Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian cancer
* An Eastern Cooperative Oncology Group performance status ≤1
* Up to 4 prior lines of therapy for ovarian cancer
* Two groups are eligible:

Group 1. Women who have not met the criteria for progressive disease following their most recent chemotherapeutic regimen were required to have:

* Demonstrated partial response or stable disease following the most recent chemotherapy regimen
* Evaluable or measurable disease, detected by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women with disease progression while receiving or following the last dose of the most recent chemotherapeutic regimen were required to have:
* Measurable disease on a CT or MRI scan performed within 28 days of first dose of ipilimumab.
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer at least 4 weeks prior to the first administration of ipilimumab.

Key Exclusion Criteria

* Histologic diagnosis of borderline, low malignant potential epithelial carcinoma
* For Group 1, women with complete response on the most recent ovarian carcinomatherapy
* Presence of known brain metastases
* Second malignancy active within the past 5 years, with the exception of locally curable cancers that have no need for subsequent therapy
* Documented history of severe autoimmune or immune-mediated symptomatic disease requiring prolonged systemic immunosuppressive treatment
* History of motor neuropathy considered to be of autoimmune origin or the of grade 2 or higher peripheral neuropathy
* History of toxic epidermal necrolysis
* Prior therapies with immunosuppressive agents within the last 2 years (excluding low-dose corticosteroids) and prior therapies with cytotoxic drugs within 4 weeks
* Chronic use of systemic immunosuppressive drugs, ongoing use of immunotherapy or biologic therapy for the treatment of cancer, or prior use of ipilimumab or any immune-stimulating agent.
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis
* Participants able to understand and willing to sign the informed consent form

Exclusion Criteria:

* Anotomical deviations of the nasal septum that significantly impair ventilation or airflow
* Pregnant or nursing women
* Positive serology for infectious disease (Hepatitis B or C, HIV) at screening
* Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).


Eligibility Criteria:
Inclusion criteria:

1. Type 2 diabetes mellitus
2. GFR\<60 ml/min
3. HbA1c \>=7.0% to \<= 10%
4. Age \>= 18 years
5. BMI \<=45 kg/m2
6. Signed and dated written informed consent

Exclusion criteria:

1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
2. Renal impairment requiring dialysis
3. Bariatric surgery
4. Impaired hepatic function
5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
6. Treatment with anti-obesity drugs
7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 70 years old
* Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (\>=) 10,000 international units per milliliter (IU/mL)
* Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
* Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
* Must be judged to be in general good health and able to receive Pegasys® and Copegus®
* No drug or alcohol abuse in the last year
* Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
* If you are a woman, you cannot be in this study if you are pregnant or nursing

Exclusion Criteria:

* Participation in any clinical trial of a HCV protease inhibitor of any duration
* Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
* Diagnosed or suspected hepatocellular carcinoma
* History of or current evidence of decompensated liver disease
* Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Carcinologic Speech Severity Index

The hypothesis of the present study is that an automatic assessment technic can measure the impact of the speech disorders on the communication abilities giving a severity index of speech in patients treated for head and neck and particularly for oral and pharyngeal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Oral and Pharyngeal cancer T2 to T4 for having a wide dynamic of deficit
* Treatment by surgery and/or radiotherapy and/or chemotherapy
* Delay after the end of the treatment of minimum 6 months.

Exclusion Criteria:

* Patients with a previous speech disorders (ie stuttering... )
* Patients not able to perform the whole task
Building Adherence to Live With And Navigate my Cystic Fibrosis (CF) Experience

The investigators research group and others have found that patient-reported adherence to all aspects of the regimen is suboptimal and objective measures suggest even poorer adherence. There is little data, however that identifies and examines the reason for nonadherence in an adult Cystic Fibrosis (CF) population or identifies effective strategies for improving adherence.

The investigators propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group). Specifically, The investigators hypothesize that MI will result in improved regimen adherence and reduced CF morbidity compared to the CFE control group.


Eligibility Criteria:
Inclusion Criteria:

* Have a doctor confirmed diagnosis of CF
* Age 16 years old or older
* Prescribed an inhaled mucolytic, inhaled antibiotic therapy, chronic macrolide therapy and/or hypertonic saline therapy for the previous 12 months.
* Scheduled for a regular visit at either the pediatric or the adult CF clinic at Johns Hopkins Hospital.

Exclusion Criteria:

* Burkholderia cepacia complex isolated from the respiratory tract within the past 2 years.
* Had a lung transplant
* Participated in NA_00008649 A pilot study of Motivational Interviewing for adults with CF.
The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease

The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD).

Interleukin (IL-12) and interleukin (IL-23) co-contain the P40 subunit, and ustekinumab (UST) is a fully humanized IgG1 monoclonal antibody that targets the P40 subunit. The conventional regimen of UST in the treatment of Crohn's disease is that after the first sufficient dose (6 mg/kg) of intravenous infusion, 90 mg UST is injected subcutaneously at the 8th week according to the patient's response, and maintenance therapy is given every 8 or 12 weeks. However, data from real-world studies suggest that the clinical efficacy of treating CD with the conventional UST regimen is less than ideal.Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab in patients with Crohn's disease .

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with moderate to severe Crohn's disease
2. Receiving treatment with ustekinumab

Exclusion Criteria:

1. Combined with other autoimmune diseases (such as systemic lupus erythematosus, Sjogren's syndrome, etc.), malignant tumors, or severe cardiovascular and cerebrovascular diseases
2. Merge active tuberculosis or severe infection
3. Liver and kidney dysfunction
4. Pregnancy or lactation period
5. Combination therapy with hormones, immunosuppressants, small molecule drugs, or other biological agents
6. Clinical data missing ≥ 30% or lost to follow-up during the follow-up period.
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.


Eligibility Criteria:
Inclusion Criteria:

3 month history of Primary Insomnia (DSM-IV criteria)

Self report sleep criteria for at least 3 nights per week in past month;

sWASO (subjective wake after sleep onset) equal or greater than 60 mins

sLSO (subjective latency to sleep onset) equal or greater than 45 minutes

TST less than or equal to 6.5 hrs

Maintain normal daytime-awake, nighttime-sleep schedule

PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights

TST between 3 to 7 hrs on 2 PSG screening nights

Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights

Exclusion Criteria:

Comorbid psychiatric disease or disorders

History or presence of breathing-related disorders

Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening

History or presence of medical or neurological condition interfering with sleep

Current use of know psychotropic effect medications

Excessive caffeine use

Use of alcohol as a sleep aid or more than 2 standard drinks/day
Room Air a Safe Alternative to Dye Injection in Ureterography

The procedure began in the Thirties .Retrograde pyelography is an essential step in most endoscopic procedure. This procedure is used as an investigation, with different indication in the past and the present, to delineate the ureter and pelvicalyceal system either before or after the operation, for example to detect any complication as a perforation and the need for stent placement. The procedure has an alternative, less invasive, the IVP. Multiple articles explored the use of air in the puncture of PCNL and to identify the posterior calyx, but to our knowledge there is no articles addressed the idea of air injection in the ureter. The greatest fear is air embolism or non-visualization of the ureter. The availability and cost of contrast material may be a problem, most urologist face

Our aim is to explore the feasibility of using Room air as a contrast material and check the safety of this procedure.

Materials and methods:

A pilot study in Assiut university hospital Urology department to evaluate the efficacy of air injection as a replacement dye injection in cases of endoscopy either in emergency or elective situation. Twenty patients were selected randomly, to evaluate the impact of retrograde pyelography (RPG) using air in cases of obstructed ureters and raised renal function.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing Urs

Exclusion Criteria:

* no
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF \< 40%
2. Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
3. Optimal drug regimen as defined in the current European guidelines
4. Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
5. Signed and dated informed consent

Main Exclusion Criteria:

* Patient implanted with or eligible to cardiac pacing as per current guideline
* Risk for neck surgery in the electrode zone within a year after enrollment
* Patient with right carotid artery stenosis
* Symptomatic hypotension
* History of peptic ulcer disease or upper gastrointestinal bleeding
* Asthma, severe COPD, or severe restrictive lung disease
* Advanced Diabetes Mellitus
* Recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
* Recent cerebro-vascular event
* Significant valvulopathy
* Advanced Renal failure
* Previous heart transplant or current LVAD device therapy
* Life expectancy \< 1 year for non-cardiac cause
* Patient included in another clinical study that could confound the results of this study
* Inability to understand the purpose of the study or to perform the procedures of the study
* Unavailability for scheduled follow-up
* Age of less than 18 years or under guardianship
* Pregnancy