cyrilzakka/clinical-trials huggingface dataset:
Islet Transplantation for Patients With Type 1 Diabetes

This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids.

Eligibility Criteria:
* Patients with type 1 diabetes with stable renal allografts
Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction

Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Willing and able to provide informed consent
3. Willing and able to comply with the study protocol
4. Seeking treatment for nasal obstruction
5. NOSE score of ≥ 60 at Baseline
6. Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):

   * Use of external nasal dilator strips (e.g., Breathe Right Strips)
   * Q-Tip test (manual intranasal lateralization)
   * Use of nasal stents
   * Cottle Maneuver (manual lateral retraction of the cheek)

Exclusion Criteria:

1. Prior surgical treatment of the nasal valve
2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
Combined Ultrasound Guided Bilateral Rectus Sheath and Erector Spinae Plain Blocks Versus Erector Spinae Plain Block for Intra and Postoperative Analgesia in Elective Abdominoplastic Surgeries. a Randomized Controlled Double Blinded Trial.

The goal of this clinical trail is to determine if bilateral erector spinae plane block alone can provide good perioperative analgesia for abdominoplastic surgery patients or it is better to give combined bilateral rectus sheath and erector spinae plane blocks to achieve effective intraoperative and postoperative analgesia with minimal morphine consumption in such operations in which there is an extensive surgical dissection and a high risk of respiratory problems.

This study is randomized controlled trail in which 40 adult patients (male or female) scheduled for elective abdominoplastic surgeries during the study duration will be randomized into to equal groups to investigate the efficacy of erector spinae plane block alone versus the efficacy of combine use of erector spinae and rectus sheath plane block for intra and postoperative analgesia in abdominoplastic surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* patients Age from 21 to 60 years ,Male and female patients ,ASA I, II patients scheduled for elective abdominoplastic surgeries during the study duration.

Exclusion Criteria:

* Patient refusal, Age less than 21 and above 60 years old, ASA III, IV patients., Infection at the site of injection, Opioid addiction, Allergy to any used substances (lidocaine, bupivacaine)., Preexisting severe or uncontrolled respiratory, renal or cardiac disease. , INR more than 1.5 and platelets less than 100000.
The 3D Stent Study

The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention.

The main question it aims to answer is:

The study hypothesis is that 3DStent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.

Exclusion Criteria:

1. Age \<18 years
2. Coronary lesions requiring total stent length \> 48 mm.
3. Body mass index \>35 kg/m2
4. Uncontrolled recurrent ventricular tachycardia
5. Cardiogenic shock
6. Unable to provide written informed consent (IC).
Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D

The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus


Eligibility Criteria:
Inclusion criteria

* Men and women, ages ≥18 years
* Official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment
* Independent living at home
* On stable regimen of BP meds (if any) with BP well controlled and/or K supplement (if any) for 2 months and which is deemed unlikely to change during the study
* Stable glucose control for 2 months by any approved method including insulin

Exclusion criteria

* Patients with type 1 diabetes (or insulin-requiring diabetes of unclear type)
* Patients on hemodialysis, with hyperparathyroidism or active cancer disease
* Patients with known metabolic bone disease
* Laboratory evidence of kidney (eGFR \< 60 ml/min) or liver disease
* Dietary calcium intake exceeding 1500mg/d (as estimated by dietary history)
* 25(OH) vitamin D levels at baseline \> 70 nmol/L
* Calciuria (\> 8 mmol/24 hours as measured by 24 hour urine collections)
* Hypo- and hypercalcemias and hypo- and hyperphosphatemias of any cause
* Medications that affect vitamin D metabolism (e.g. antiepileptic drugs, calcimimetics, 1-34 PTH (Forsteo) vitamin D therapy over and above 400U daily 6 months prior to enrollment and during the study)
* Foreseeable need for adaptation of either glucose- or blood pressure lowering during the next 6 months as decided by the family physician or the treating diabetologist - see above
* History of binge eating or wt gain or loss exceeding 6 kg in past 18 months
* Patients on any type of inhibitors of plasma coagulation (i.e. coumarine, heparins)
Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer

The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman at least 18 years old.
* Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
* Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
* Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
* Measurable and non-measurable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* History or known presence of Central Nervous System (CNS) metastases.
* History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
* Nasopharyngeal carcinoma.
* Prior systemic treatment for metastatic and/or recurrent SCCHN
* Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
* Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
* Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
* Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing \[without monitoring program\])
Bisphosphonate-coated Dental Implants

Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.


Eligibility Criteria:
Inclusion Criteria:

* Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.

Exclusion Criteria:

* Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.
* Local exclusion criteria were: previous tumour, trauma and surgery.
* Also patients with Cawood \& Howell class IV - VI maxilla-bone were excluded.
Fluoxetine vs. Brief Psychotherapy for Major Depression

In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main hypothesis is that brief psychotherapy is as effective as fluoxetine.

This study is a randomized comparison of two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. The patients are recruited from occupational health services and suffer from mild to moderate major depressive disorder. The treatments last for 16 weeks. The main outcome measures include HAM-D, BDI, SOFAS, Rand-36. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment using Positron Emission Tomography (PET) . The main hypothesis is that brief psychotherapy is as effective as fluoxetine, but differences between the treatments are seen in PET scanning.

Eligibility Criteria:
Inclusion Criteria:

* MDD (mild to moderate)
* HDRS 15 or more, age 20-60 years
* No treatment for preceding 4 months
* No DSM-IV axis I or II comorbidity
* No severe somatic illness
* No contraindications for fluoxetine treatment
Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction

The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of a PMCF Plan.

This is an observational post-market study. Women will be screened for participation where the decision to undergo prophylactic R-NSM surgery has already been made as part of their medical care. In order for women to be enrolled, surgeons must perform the surgery according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System. Women will sign an informed consent form for their participation in the study. Women will be prospectively followed at 6 weeks, 3 months and 1 year post-surgery, which is within the standard of care. Data will be collected prospectively from the medical records and women will be asked to complete preoperative and postoperative questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a woman, candidate for a prophylactic R-NSM surgical procedure (unilateral or bilateral) according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System
* Subject has cup size A, B or C,
* Subject is 18 years of age or older,
* Subject is a candidate for reconstruction,
* Subject is willing to participate as demonstrated by signing the informed consent,
* Subject benefits from a health care system/insurance.

Exclusion Criteria:

* Subject is pregnant or is lactating,
* Subject has active cancer or pre-cancer (Ductal Carcinoma In Situ \[DCIS\]) on breast to be robotically operated,
* Subject has cancer involving the Nipple Areolar Complex (NAC), inflammatory breast cancer or T4d lesion, clinical evidence of skin involvement or T4b lesion, and clinical or radiological evidence of chest wall invasion.
* Subject has ASA score ˃ III or has known thromboembolism risks or, is at risk in relation to anesthesia,
* Subject presents severe lack of cooperation due to psychological or severe systemic illness,
* Subject has medical conditions contraindicating general anesthesia or surgical approach,
* Subject is part of vulnerable population (e.g., prisoners, mentally disabled).
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

Condition

Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.

Not included:

Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Eligibility Criteria:
Inclusion Criteria:

1. Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
2. Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
3. Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) \& preferably within 6 weeks of entry.

Exclusion Criteria:

1. Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
2. A primary prostate, breast, lung or brain tumour,
3. Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response.

Other protocol-defined inclusion / exclusion criteria may apply.
Leveraging Plasma Concentration Levels to Optimize Extracorporeal Treatment in Acute Diquat Poisoning

This study aimed to evaluate the clinical value of plasma diquat concentration in guiding personalized extracorporeal treatment regimens for patients with acute diquat poisoning.

Diquat (1,1'-ethylene-2,2'-bipyridinium) is a bipyridine herbicide with a structure similar to paraquat. Upon ingestion, diquat induces harmful effects on multiple organ sysmtems, including the gastrointestinal, kidney, liver, musculoskeletal, respiratory, cardiovascular, and central nervous systems. Lethal diquat poisoning primarily manifests as severe toxic encephalopathy and circulatory failure, leading to a high mortality rate. Extracorporeal treatment is widely used in cases of diquat poisoning. ECTRs refer to treatments where toxins are removed outside the body, usually through a circuit. Specifically, ECTRs include hemoperfusion (HP), hemodialysis (HD), continuous kidney replacement treatment (CKRT), extended dialysis, peritoneal dialysis (technically intracorporeal), hemofiltration, hemodiafiltration, therapeutic plasma exchange, and albumin/"liver" dialysis. Several studies have demonstrated that HP can significantly reduce plasma paraquat concentrations, and HP is superior than HD in the clearance of diquat. Additionally, clinical case reports have shown that HP, often combined with CKRT, effectively reduces diquat levels and improves clinical outcomes in patients with diquat poisoning. Continuous veno-venous hemodiafiltration (CVVHDF), a type of CKRT, is primarily used for patients with acute kidney injury (AKI) or fluid overload. The primary goal of CVVHDF is to provide continuous kidney support by removing excess fluids and solutes, there by maintaining electrolyte and acid-base balance. AKI, which is a common consequence of diquat poisoning, impairs kidney function and thus reduces the kidney's ability to clear diquat formula from the plasma. A study reported an AKI incidence of 73.3% in patients with diquat poisoning, indicating many may need CVVHDF. However, the Extracorporeal Treatments in Poisoning (EXTRIP) workgroup does not provide a definitive recommendation on the use of ECTR for diquat poisoning. Aside from case reports and series, there is a lack of evidence to guide clinicians on the optimal application of ECTR in managing diquat poisoning.

Eligibility Criteria:
The inclusion criteria were:

1. history of oral exposure to diquat solution reported by patient or proxy;
2. a specimen for the plasma diquat concentration collected immediately upon admission;
3. documentation that patients or, in case of unconsciousness of the patient, legal proxies were aware of and agreed to treatment plans.

Patients were excluded if:

1. they had ingested other toxins in addition to diquat (qualitative toxicological screening tests);
2. diquat was not detected in specimens, or plasma concentration data were unavailable;
3. patients with an exposure time (time from exposure to presentation) longer than 48 hours;
4. patients had ECTR prior to ED presentation.
A Study to Collect Blood Samples From Patients With Spinal Muscular Atrophy for Biomarker Analysis

In this single center study blood samples for biomarker analysis will be collected from patients with spinal muscular atrophy. Up to 21 mL blood will be drawn from eligible patients at a single visit.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified as 5q-autosomal recessive spinal muscular atrophy (SMA) type I, II or III as judged by their neurologist upon diagnosis
* Ability and willingness to provide blood samples
* Willingness (by the patient or patient's parents or legal guardian) to complete to their best ability a questionnaire which requests specific clinical and genetic information
* Able to participate and willing to give written informed consent or assent. Informed consent will be obtained from the patient, or the patient's parent or legal guardian.

Exclusion Criteria:

* Any known genetic condition other than spinal muscular atrophy, unless it is not interfering with the purpose of this study based on the Sponsor's judgment
* Participation in a clinical trial (except observational studies) within the previous 14 days
* Donation of blood or significant blood loss within three months prior to screening
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of this study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
Comparison of Anti-inflammatory Effects of Seroflo and Seretide in Patients With Asthma

The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway inflammation in asthmatic patients in the same as Seretide.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 years
* Patients with asthma diagnosed by according to the American Thoracic Society criteria
* A baseline FEV1 \> or = 50% predicted with a reversibility of FEV1 after therapy with inhaled salbuterol (2.5 mg) of FEV1 12% or with provocative concentration of a methacholine causing a 20% fall in FEV1 (PC20) of \< or = 8 mg/mL
* Prescribed use of inhaled corticosteroids (any brand) for at least 12 weeks prior to study entry
* The daily prescribed dose of inhaled corticosteroids during the last 4 weeks prior to study entry should have been constant and at least 250 μg/day of fluticasone at least 400 μg/day of budesonide at least 500 μg/day of any other beclomethasone
* Be able to provide written informed consent

Exclusion Criteria:

* Any asthma exacerbation or respiratory tract infection affecting asthma within 4 weeks prior to the randomization visit
* Intake of oral, parenteral corticosteroids within 4 weeks and/or depot parenteral corticosteroid within 12 weeks prior to the randomization visits
* Current or previous smoker with a smoking history of \> or = 10 pack years
* Previous randomization of treatment in the present study
* Known or suspected hypersensitivity to study therapy
* Use of any β-blocking agent, including eye-drops
* Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive pill measures
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.


Eligibility Criteria:
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
Litramine in Weight Maintenance

The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening
* BMI 25-35 before initial weight loss
* Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens

Exclusion Criteria:

* Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family)
* BMI \< 18.5
* Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation