cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3

To demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone.

IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.

Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in increases in CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process. To develop appropriate clinical experience with the combination, this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial.

Patients are randomized to control therapy with antiretrovirals alone (36 patients) or antiretrovirals plus IL-2 given subcutaneously every 12 hours for 5 days every 8 weeks. Three doses of IL-2 are studied, with 12 patients evaluated at each dose.

If at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicities, the next 12 patients randomized are treated with the next higher dose; if this dose is tolerated, the last 12 patients randomized receive the highest study dose. Patients enrolled at the first two doses of IL-2 who complete three courses have their dose escalated to a maximum of the highest dose.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a CD4 cell count greater than or equal to 300 cells/mm3.
* Are at least 18.
* Have been on antiretroviral therapy for at least 7 days prior to study entry.

Exclusion Criteria

You will not be eligible for this study if you:

* Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect your safety or ability to complete the study.
* Have a history of cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system (CNS) abnormality, or an autoimmune/inflammatory disease.
* Are pregnant or breast-feeding.
* Have ever received IL-2.
Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)

The frequency of cardiac amyloidosis among patients presenting with a so-called left ventricular hypertrophy remains unknown. This problem is especially relevant in the Caribbean's, where an amyloidosis-prone mutation of transthyretin gene might be frequent.

Cardiac amyloidosis is a very poorly known disease, in its frequency, its mechanisms, its treatment. This lack of knowledge is a major limitation to the improvement, indispensable, of the care of the patients. In clinical routine, particularly in West Indies-Guyana, cardiac amyloidosis is a disease poorly identified, whose management remains to be optimized. Concordant observations suggest that the frequency of the disease could be significant in the Antilles-Guyana: aging of the population, high frequency of an amyloidogenic mutation (Val122Il mutation of the transthyretin gene) found in 4% of the Afro-American population, recent identification in Martinique by a neurology team of a new founding mutation of the transthyretin gene that may cause the disease.

These elements justified the setting up of a multidisciplinary group whose objective is to contribute to the improvement of screening, treatment, and follow-up of patients with cardiac amyloidosis.

An identical diagnostic algorithm will be followed in all centers. Therapeutic management will be left to the discretion of the health care teams, who will be communicated regularly, the latest management recommendations.

A frequency of 30% is expected and will be assessed with a power of 80% and an alpha risk of 0.05. Quantitative and qualitative data will be described as usual. Differences between groups will be assessed with parametric or non-parametric tests.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Residency in French Caribbean Regions
* Access to healthcare coverage,
* Written informed consent obtained

Exclusion Criteria:

* Evidence of another cause for left ventricular hypertrophy (uncontrolled severe high blood pressure, untreated severe aortic stenosis, family history of hypertrophic cardiomyopathy)
* Inability to deliver informed consent,
* Presence of a known severe disease impending participation in the study
Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease

The purpose of this trial is to assess whether rotigotine has an effect on the electrical activity of the heart. Moxifloxacin infusion is used as positive control to assess assay sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age
* Advanced-stage idiopathic Parkinson's disease requiring treatment with levodopa.
* Nonchildbearing potential

Exclusion Criteria:

* Atypical Parkinson's syndrome(s).
* History of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant.
* Significant tremor or dyskinesias.
* Severe dysfunction of the autonomic nervous system.
* History of transient ischemic attack or stroke within the last 12 months.
* Conduction abnormality or relevant cardiac dysfunction and/or myocardial infarction within last 12 months.
* History or current condition of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia), or a family history of long QT syndrome and/or of Torsade de Pointes.
* No stable sinus rhythm: more than 20 ectopics/h.
* Any other clinically relevant ECG abnormality.
* History or current condition of epilepsy and/or seizures.
* History or current condition of atopic or eczematous dermatitis, psoriasis, or another active skin disease.
* History or current condition of symptomatic orthostatic hypotension.
* History or current condition of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis.
* History of glucose 6-phosphate dehydrogenase deficiency.
* History of tendonitis or tendon rupture with quinolone antibiotics.
* Renal or hepatic dysfunction.
* Treatment with dopamine agonists, MAO A inhibitors, reserpine, or alpha-methyldopa
* Therapy known to produce a nontrivial prolongation of the QT interval.
Follow Up on Freestyle Valves in Children

The purpose of this study is to determine if the Medtronic Freestyle porcine valve is effective over a long period of time when it is used to replace the valve that normally allows blood to flow from the right lower pumping chamber of the heart to the lungs.

During the time between June 1998 and June 2006, the Medtronic Freestyle® porcine aortic root (Medtronic, Minneapolis, MN) was used for reconstruction of the right ventricular outflow tract in children that underwent surgery at Children's Healthcare of Atlanta. These children were born with heart problems that made it difficult for blood to flow from the lower right chamber of the heart to the lungs where it would normally pick up oxygen to be used by the body. Consequently, these children required surgery to repair the valve and eliminate this restriction of blood flow to the lungs in order to preserve life. In this case, the Freestyle valve was used. It is a relatively new valve and it is not known how it functions and how it impacts overall heart function over a long period of time. We are requesting permission to recruit volunteers that have received the Freestyle valve for this purpose in order to determine its long term performance. Specifically, we are seeking volunteers that are willing to have an echocardiogram performed. It is through the evaluation of a recent echocardiogram, as it compares to previous echocardiograms performed on the same patient, that the usefulness of the Freestyle valve will be evaluated for its durability and its long term impact on heart function.

Eligibility Criteria:
Inclusion Criteria

* Patients that have received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction that have not had a standard of care echocardiogram performed in the last 12 months.
* Patients that have received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction whose most recent echocardiogram is not useful for evaluating the study points despite the fact that it may have been performed within the last 12 months.
* Informed consent obtained from the legal guardian or patient if \> 18 years of age.

Exclusion Criteria

* Patients that have not received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction.
* Patients that are eligible to participate based on the previous criteria for whom informed consent is not obtained from the patient or legal guardian.
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
* Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
* Subjects with FIGO Stage IIIC or IV disease must either:
* Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
* Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
* Previous abdominal and/or pelvic external beam radiotherapy
* History of central nervous metastasis
* History of arterial or venous thromboembolism within 12 months prior to randomization
* Clinically significant cardiovascular disease within 12 months prior to randomization
Hypomagnesemia and Hypocalcemia Association Following Thyroidectomy

Magnesium plays a role in the active transport of calcium (Ca+2) and potassium ions across cell membranes. Most of it is intracellular or in the bone , however less than 1% of magnesium is in the blood serum. Hypoparathyroidism post thyroidectomy leads to acute Hypocalcemia that leads to hypomagnesemia. The relation of Ca+2 and magnesium (Mg+2) metabolism is complex and mainly related to the interaction of these cations with parathyroid post thyroidectomy. (Mg+2) is an essential regulator of Ca+2 flux and intracellular action of Ca+2. Hypomagnesaemia impairs hypocalcaemia induced PTH release, which is corrected rapidly after magnesium replacement. Attempting to correct only hypocalcemia may prolong symptoms. It is important to monitor both Ca+2 \& Mg+2 levels following thyroidectomy to facilitate prompt resolution of symptoms.

Aim of the study: is to highlight the prevalence of hypomagnesemia following thyroidectomy and its association with hypocalcemia which mandate early recognition and treatment to prevent prolongation of hypocalcemia and permanent hypoparathyroidism

Methods:

IRB obtained (E20-4615) informed consent taken from all patient. This is prospective open Label observational study in patients underwent thyroidectomy .the study period was from January 2019 to January 2020. Total of 74 patients with normal renal function. Corrected serum Ca+2, magnesium, phosphate level and vitamin D level are all checked pre operatively and in the first post-operative day.

Result:

Post thyroidectomy 56.8% of patients had hypomagnesemia. 59.5.1% patients had hypocalcemia and 41.9% of patients had low both Ca+2 and Mg+2 (P=0.004)

Conclusion:

Hypocalcemia and hypomagnesemia following thyroidectomy is of multi factorial related mainly to Ca+2, Mg+2 interaction.

Keywords: Hypomagnesemia. Hypocalcemia. Thyroidectomy

Methods:

A prospective study for 1 year starting 1/1/2019 to 1/1/2020. A total 74 patients with normal renal function .admitted for thyroidectomy. Preoperative serum calcium, magnesium, phosphate and vitamin D level all checked. Postoperatively corrected serum calcium, magnesium and phosphate level are checked. The serum calcium less than 2.12mmol/l is corrected with oral or IV calcium infusion plus vitamin D depending on the severity of symptoms. Any serum magnesium less than 0.75mmol/l is corrected with infusion magnesium sulfate. Calcium and magnesium level monitored and corrected according to the result.

Statistical analysis:

Statistical analysis was performed using statistical package for the social sciences (SPSS) version 23.0 software (SPSS Inc., Chicago ,IL,USA). If normal distributed, continuous variable were presented as mean (SD) Student t-test for paired observation was used for statistical. Pearson Chi-square test was used to compare the percentage for categorical variables. P less than 0.05 indicate statistically significant difference

Eligibility Criteria:
Inclusion Criteria:

all patients admitted for thyroidectomy -

Exclusion Criteria:

patient with renal disease

-
Knee Stiffness in Fibrosis Diathesis

At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients will be checked for signs of fibrosis diathesis. This will be done by examining their hands for Dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of Dupuytren's contracture. These include family history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis.

This way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and 6 months will be retrieved in the charts, the ROM at 12 months will be measured at that time. Also, additional procedures performed to increase ROM postoperatively will be retrieved from the charts (e.g. continuous passive motion, mobilization under anesthesia). Other causes for knee stiffness will have to be recorded, since these will be the most important exclusion criteria.

In the patients with clear signs of finger contractures, any impression of increase of contracture over the past 12 months will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a total knee replacement for primary gonarthrosis with a minimum follow-up of 1 year

Exclusion Criteria:

* Patients undergoing a TKA for other reasons than primary gonarthrosis, e.g. after infection, posttraumatic arthritis,hemophilia,...
* Patients who had other problems after their TKA resulting in knee stiffness, e.g. infection, bleeding,...
Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Daily Activities Questionnaire.

Dyspnea, referred to by patients as "shortness of breath" or "breathlessness," is frequently associated with decreases in functional status, quality of life, and disabilities. Currently available questionnaires do not specifically address the shortness of breath component of COPD. The development of a patient reported outcome questionnaire that will specifically assess Shortness of Breath with Daily Activities (SOBDA) in patients with COPD is needed.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 40 years of age
* Established clinical history of COPD by ATS/ERS definition
* Former or current smoker \> 10 pack years
* Evidence of dyspnea

Exclusion Criteria:

* Has a respiratory disorder other than COPD
* Cancer not in complete clinical remission
* Clinically significant cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine, or hematological abnormalities that are uncontrolled
Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy in Reducing Insomnia Among Adult Population

This experimental study aims to develop an internet-based self-help cognitive behavioural therapy for insomnia that reduces insomnia symptoms and its associated adverse outcomes among people with sub-threshold insomnia symptoms. In particular, this study compares the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population.

The online CBT-I course will consist of an introductory module, followed by 6 weekly modules. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.

Although the Internet self-help CRT-I program have shown promising effect on dealing with insomnia symptoms, the effectiveness of internet self-help CBT-I in adults with sub-clinical insomnia symptoms in Hong Kong is under-studied. Therefore, the present study aimed to compare the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population. We hypothesized that (1) participants who received CBT-I treatment would have improved insomnia symptoms after the intervention as compared with the wait-list controls; (2) participants from CBT-I would have better sleep hygiene, and less dysfunctional beliefs about sleep and pre-sleep arousal after the intervention as compared with the wait-list controls; (3) participants from CBT-I would have improved mental health, daytime functioning, quality of life, and general well-being after treatment, as compared with the wait-list controls.

The online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Age ≥18 years
* Insomnia Severity Index score \> 7 and \< 22
* Being able to read Chinese
* Have a computer, tablet and/or smartphone device with Internet access
* have a regular email address
* Willing to give informed consent and comply with the trial protocol

Exclusion Criteria:

* Receiving psychological treatment at least once per month
* Currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, and sleeping pills regularly
* Carrying a diagnosis of psychosis or schizophrenia
* Participating in any other academic studies or clinical trials related to insomnia
* Having current suicidal plans or acts or having had suicidal plans or acts within the past 12 months
* Shift workers
Gene Mutations and Rescue in Human Congenital Diaphragmatic Hernia

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm, the muscle that separates the chest cavity from the abdominal cavity, does not form properly. When an opening is present in the diaphragm, organs that are normally found in the abdomen can move up into the chest cavity. The primary objective of this study is to generate information about the hereditary basis of congenital diaphragmatic hernia and abnormal lung development. Our long-term goal is to identify ways to treat babies in utero with effective but safe drugs to speed up lung development before birth.

This study uses a combination of clinical, molecular biological, and developmental strategies to better understand the genetic basis of congenital diaphragmatic hernia. Ongoing projects at Massachusetts General Hospital include identification of novel genes affecting diaphragm and lung development in a) mouse models using laser capture, microdissection, expression arrays, and statistical and bioinformatics analysis and b) human kindreds with multiple affected family members using linkage analysis and exome sequencing.

Research projects based at Children's Hospital Boston include a) continued recruitment of a population of patients with congenital diaphragmatic hernia who are carefully phenotyped for entry into an extensive database, b) collection of biological samples belonging to the phenotyped cohort of patients, c) next-generation sequencing on candidate genes and d) molecular cytogenetic studies such as comparative genomic hybridization and subtelomeric fluorescence in situ hybridization.

Over 500 patients with congenital diaphragmatic hernia and their families have been recruited to date and efforts are ongoing to double this number. The investigators hope that the information gained through identifying the genes that contribute to congenital diaphragmatic hernia will provide the foundation for future efforts to develop effective interventions for the treatment of this disease.

Eligibility Criteria:
Inclusion Criteria:

All individuals affected with a congenital diaphragmatic hernia (CDH), or with a family history of CDH

Exclusion Criteria:

Individuals with no personal or family history of a CDH