cyrilzakka/clinical-trials huggingface dataset:
Surgical Management of Irreparable RC Tears

The primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. The secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.

Prospective, Non-Randomized Cohort Study The surgeons will decide which surgical reconstruction technique should be used to treat patients who have a massive (2+ tendons) or irreparable (Grade 3 or higher fatty infiltration into infraspinatus tendon) rotator cuff tear in the primary or revision setting. Surgical options include arthroscopic superior capsular reconstruction (SCR), arthroscopic assisted latissimus dorsi transfer (aaLDT), or arthroscopic assisted lower trapezius transfer (aaLTT), with arthroscopic biceps tendoesis/tenotomy as a control group.

Each patient will receive an X-ray and MRI to indicate reparable subscapularis tear, teres minor pathology, grade of muscle fatty infiltration, AHI, CSA, Hamada grade, and arthritis grade.

Patients will be assessed pre-operatively and again post-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months to collect patient reported outcomes and complications. Assessments will include clinical and shoulder motion evaluations to gauge shoulder range of motion and pathology, as well as questionnaires that evaluate the patients shoulder mobility, ability, pain, and surgical satisfaction. Any adverse events post surgery will also be recorded at the defined assessment time intervals (6 wks, 3m, 6m, 12m, 24,m) and will specifically monitor temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent moderate/severe pain, tendon or graft rupture, and humeral head superior migration.

Graphical comparisons will be made of the patient's recovery for each surgical technique as well as an analysis of patient specific factors based on their demographics forms which could influence the recovery curves.

Eligibility Criteria:
Inclusion Criteria:

* massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting.

  * Definition of "irreparable": grade 3 or higher fatty infiltration into the infraspinatus

Exclusion criteria:

* Protected populations: prisoners, military, non-English speakers, age \<18 years
PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Women who are able to provide informed consent
* Age 20 years and older
* Diagnosis of stage II to III breast cancer
* Patients who had undergone surgery for breast cancer treatment.
* Planning to receive anthracycline -based adjuvant chemotherapy
* Have adequate bone marrow, liver, and renal function
* ECOG ≦1
* Willing and able to complete quality of life questionnaires.

Exclusion Criteria:

* Pregnancy or lactating women.
* Baseline BFI score \>3.
* History of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators.
* History of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer.
* Known severe allergy to Astragalus membranaceus or its mayor extracts (polysaccharides).
Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease

The purpose of this study is to explore the efficacy of the drug Amantadine for the treatment of freezing of gait in patients with Parkinson's Disease. The investigators hypothesize that amantadine is useful for management of freezing of gait in subjects with Parkinson's Disease.

Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with idiopathic PD as determined by UK brain bank diagnostic criteria
2. H\&Y stage 2.5-3
3. Presence of freezing of gait (FOG) as determined by UPDRS Part I score \> 2
4. Ability to walk for 2 minutes in the ON and OFF state
5. Stable regimen of PD medications for 30 days prior to screening
6. Ability to comply with the study procedures
7. If female, be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
8. Willing and able to provide informed consent.

Exclusion Criteria:

1. Presence of other co morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
2. Presence of freezing of gait (FOG) ONLY in medications ON state
3. Presence of freezing of gait (FOG) ONLY in medications OFF state
4. Presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) \<20
5. Presence of clinically significant depression as determined by geriatric depression scale (GDS)- 15\>5
6. Presence of clinically significant hallucinations
7. Inability to sign informed consent
8. Participation in the physical therapy aimed at management of PD for the duration of the study (PT for orthopedic issues will be allowed)
9. Contraindications for use of Amantadine ( prior history of allergic reaction, history of known renal insufficiency with Cr \> 2)
10. If female, be pregnant or lactating
Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial

Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction.

Opposite to old studies of cervical ripening, some recent studies have shown promise in reducing labor time and risk of cesarean delivery with combination methods. The effectiveness of this procedure is of major clinical importance and has a large impact in our quotidian practice.

The objective is to compare the effectiveness of a combined new method to current guidelines of our department

We designed a randomized trial that will compare two groups: misoprostol-cervical Foley simultaneously and the current department guidelines (misoprostol alone/dinoprostone alone).

Inclusion criteria: full-term (≥ 37 weeks of gestation), singleton, vertex-

Eligibility Criteria:
Inclusion Criteria:

* full-term (≥ 37 weeks of gestation)
* singleton
* vertex-presenting gestations
* with no contraindication to vaginal delivery
* intact membranes
* Bishop score \< 7 and cervical dilation ≤2 cm

Exclusion Criteria:

* contraindication for misoprostol
* history of previous caesarean
* rupture of membranes,
* fetal or maternal morbidities (fetal major abnormalities, FIGO definition of pathological CTG, HELLP syndrome, preeclampsia or hypertension with severe features, fetal growth restriction)
Role of Terminal Warm Blood Cardioplegia as Myocardial Protection in the Use of Histidine-Tryptophan-Ketoglutarate Cardioplegia in Complex Congenital Heart Surgery

Terminal warm blood cardioplegia (TWBC) has been shown to enhance myocardial protection in adult patients. Even in pediatric patients, the use of cold blood cardioplegia followed by administration of TWBC will provide cardioprotective effect similar to adult patients. Histidine-tryptophan-ketoglutarate (HTK), is attractive for cardiac surgeons because it is administered as a single dose and is claimed to offer myocardial protection for a period of up to 180 minutes allowing performance of complex procedures without interruption. Merging the use of TWBC on the use of HTK cardioplegia, especially for pediatric cardiac cases, have not been investigated. This technique is expected to provide a longer ischemic time and a protective effect against reperfusion injury.

The design of this study is a randomized controlled trial in children younger than 5 years old undergoing heart surgery with cardiopulmonary bypass. The objective of this study is to assess the role of TWBC in use of HTK cardioplegia compared with the use of HTK cardioplegia alone in open heart surgery of complex congenital heart disease. This study will be conducted at the National Cardiac Centre Harapan Kita Hospital Indonesia. Surgery will be performed in the operating room of Pediatric and Congenital Cardiac Surgery Unit. This study uses non-probability consecutive sampling. The samples are all pediatric patients with complex congenital heart disease who meet the inclusion criteria and not excluded by the exclusion criteria. Patients will be divided into two groups, the treatment group who received HTK cardioplegia and TWBC, and the control group that only received HTK cardioplegia alone. Hearts will be arrested with HTK solution during cardiac operation. HTK cardioplegia will be given through the aortic root at a dose of 50-60 ml/kg after aortic cross-clamped. For the treatment group, TWBC will be given shortly before the aortic cross clamp is removed at a dose of 10 to 15 ml/kg with temperature of 34 to 36 oCelcius. TWBC is a mixture of blood and HTK kardioplegia with a composition of four to one. The outcomes of this study are malondialdehyde as a marker of reperfusion injury due to oxidative stress, caspase-3 as a marker of apoptosis, cTn-I as a marker of myocardial cell damage and the incidence of low cardiac output syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with complex cyanotic congenital heart disease who scheduled for pediatric cardiac surgery
* Aristotle score is 8 and above
* Parents of patient have written informed consent and agree to follow the research procedures

Exclusion Criteria:

* Patient diagnosed with an other congenital defect
* Patient diagnosed with rare congenital heart defect and high mortality rate (such as hypoplastic left heart syndrome)
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer

To evaluate quality of life in patients after 10 days pause of thyroid medication (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine uptake and treatment in a double-blinded, randomised cross-over design.

Patients with a thyroid follicular or papillary cancer referred to radioiodine treatment in oncological department . The patients after thyroidectomy will be treated with Liothyronine and this treatment will be paused 10 days before radioiodine. As a routine these patients will be re-evaluated with iodine uptake 4 months later.

The patients will be randomised to either T3 pause related to the first radioiodine treatment and Thyrogen injection (recombinant TSH) related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.

All medication given in the 10 days period right before radioiodine treatment/uptake will be delivered to the patients and marked with a protocol number. In the period with T3 pause the patients will be given placebo tablets and an injection of saline (instead of Thyrogen) before treatment/uptake at the similar time as given the Thyrogen injection. A nurse otherwise not involved in the study will give the injection.

Patients will be evaluated by VAS, SF-36, and Eortc QLC30 (version 2.0) before radioiodine treatment and 3 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Follicular or papillary thyroid cancer

Exclusion Criteria:

* \< 18 or \> 75 years old
* Pregnant or lactating women
The Effects of MAP and EtCO2 on Venous Sinus Pressures

The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.

To prospectively evaluate the effect of changes in end-tidal carbon dioxide and arterial blood pressure on venous sinus pressure measurements in patients undergoing venous sinus stenting under general anesthesia. Venous sinus pressure measurements will increase with increases in both arterial blood pressure and end-tidal carbon dioxide concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Adults determined to be candidates for venous sinus stenting
CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation

The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.

Allogeneic hematopoietic stem cell transplantation (HSCT) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. Natural killer (NK) cells are immune cells that recognize and kill virally infected cells and tumor cells. NK cells are identified by the expression of the CD56 surface antigen and the lack of CD3. Their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing an allogeneic HSCT from a sibling donor, as treatment for a hematological malignancy. The conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment
2. Patient and donor Age \>18 years
3. Patients and donors must have signed an informed consent form
4. The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
5. Donor must be fit to undergo leukapheresis

Exclusion Criteria:

1. Life expectancy \< 3 months
2. ECOG performance status 3 or 4
3. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
4. Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
5. HIV-positive patients
6. Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent
Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia

This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.

This is a multicenter, prospective, translational study. Pharmacological treatments will not be object of the present study. Patients will follow the prescribed therapeutic indications according to regular clinical practice. Biological samples and clinical data will be collected at fixed timepoints.

Aim of the study is to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.

A total of 75 AML patients affected by primary or secondary AML, at diagnosis ( 45 patients) or relapse (30 patients) will be enrolled in the protocol (18 months for patient enrolment). Blood,BM and saliva samples will be collected from each patients; for patients enrolled at diagnosis, samples will be collected before and after treatment with hypomethylating agents.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with new diagnosis of primary or secondary AML candidate to first line treatment with hypomethylating agents (specific for Cohort 1) Patients with primary or secondary AML who relapse after/during first line treatment with hypomethylating agents (specific for Cohort 2)

   for each cohort:
2. Participant is willing and able to give informed consent for participation in the study
3. Male or Female, aged \>18 years
4. Availability of clinical data

Exclusion Criteria:

1. Age \< 18 years
2. AML M3 subtype according to FAB classification
Effects of CLA Supplements on Body Weight and Fat Oxidation

Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatment emphasis has turned to small weight losses obtained through non-restrictive diets and prevention of weight regain. This is a study to determine if 6 months of consumption a purified form of CLA will result in greater loss of body fat than control and to determine whether CLA consumption increases total fat oxidation, which would help explain why the weight loss occurs.

Subjects were screened and then underwent baseline evaluation. The substudy evaluation measured 24-h energy expenditure and substrate utilization by using a whole-room indirect calorimeter. Dietary fat oxidation was measured by mixing \[1-13C\]oleate and D31-palmitate into a breakfast meal and then collecting breath carbon dioxide and urine to measure the end products of oxidation. Subjects were then provided either 4 g/d of 78% active CLA isomers (3.2 g/d: 39.2% cis-9,trans-11 and 38.5% trans-10,cis-12) or 4 g/d of safflower oil placebo as 1-g gel capsule supplements. The baseline evaluations were repeated 6 mo later.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-29.9 kg/m2
* Absence of a weight change of greater than 3 kg in the previous 6 months

Exclusion Criteria:

* Presence of a physical limitation to walking exercise
* Current or recent (6 months) enrollment in a commercial or self-prescribed weight loss program
* A history of metabolic disease-ie. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study
* A history of a psychiatric or eating disorders Ÿ Presence of metal implants that would interfere with body composition analysis
* Fasting plasma cholesterol \>300mg/dl or triglycerides above 500 mg/dl.
* Abnormal EKG
Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab

Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age 18 ≤ x ≤ 65 years and currently employed at the baseline study visit
* Diagnosis of diabetes mellitus (type 1 or 2)

  o Any one of the following will be considered to be sufficient evidence that diabetes is present:
* Current regular use of insulin for treatment of diabetes
* Current regular use of oral anti-hyperglycemia agent for the treatment of diabetes
* Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
* Central diabetic macular edema present on clinical examination or or evidence indicating disease activity on spectral domain OCT.
* Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
* Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
* Participation in another ocular investigation or trial simultaneously
* Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110)
* Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
* Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema
* An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy)
* Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)
* Evidence of active neovascularization of the iris or retina
* Evidence of central atrophy or fibrosis in the study eye
* Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
* Previous use of intraocular or periocular corticosteroids in the study eye in the previous 120 days
* Previous treatment with anti-angiogenic drugs in the study eye i.e. pegaptanib sodium, bevacizumab, ranibizumab, aflibercept within 120 days prior to baseline
* History of vitreous surgery in the study eye
* History of cataract surgery within 3 months of enrollment.
* History of YAG capsulotomy within 2 months of enrollment.
* Visual acuity \<20/400 in the fellow eye
* Uncontrolled glaucoma (pressure \>30) despite treatment with glaucoma medications.
* History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.