cyrilzakka/clinical-trials huggingface dataset:
Predictors of Drug Hypersensitivity in HIV Infected Subjects

A case-control study to look at hypersensitive and tolerant individuals matched for HLA genetic predisposition, when considering predictors of drug hypersensitivity.The study aims to identify the immunological factors increasing the risk of drug reactions in HIV positive individuals.

1. To determine in a case control study clinical parameters associated with drug HSR to abacavir, nevirapine and efavirenz in HIV infected subjects.
2. To measure functional and numerical differences in DC populations and responses to TLR ligands in patients with HSR and tolerant subjects sharing genetic markers for susceptibility to HSR.
3. Identify the role of different DC populations in the development of abacavir reaction by mixing and depletion studies in sensitized subjects and in in vitro assays for abacavir hypersensitivity.
4. To measure T cell parameters including T cell viability in culture, and expression of fas and fasL on blood mononuclear cells in HIV infected controls and HSR patients.
5. To measure blood T cell populations including drug reactive T cells and T regulatory cells in tolerant and reactive subjects with genetic susceptibility to Abacavir and Nevirapine HSR.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients on treatment with the drugs Efavirenz, Nevirapine, or Abacavir.
* Age over 18 Cases are those who have had a hypersensitivity reaction, and controls are those who have had no reaction
Exercise and Nutrition Intervention in Ovarian Cancer

The objective of this multicenter randomized controlled trial is to compare a 6-month exercise and nutrition intervention (intervention group, IG) aimed at maintaining or improving physical functioning and quality of life with usual care (control group, CG) in ovarian cancer patients.

The main question it aims to answer is:

• Can an exercise and nutrition program improve physical performance during and after active treatment for ovarian cancer?

Participants of the IG will undergo:

* Weeks 1-18: approximately 15-30 minutes of daily exercise (cardio, resistance, and balance exercises); nutritional counseling focusing on malnutrition (protein-energy malnutrition).
* Weeks 19-25: More intense daily training; nutritional counseling focusing on the Mediterranean diet.

The study design includes 3 survey time points:

* Baseline: After surgery and before starting chemotherapy
* T1: After chemotherapy (week 19)
* T2: After intervention (week 26)

The primary outcome is:

• 6-minute walk test, 6 months after enrollment (T2)


Eligibility Criteria:
Inclusion Criteria:

* Patients with FIGO II-IV stage ovarian, fallopian tube, or peritoneal carcinoma
* Patients must be treated with surgery and chemotherapy
* Patients receiving adjuvant or neoadjuvant chemotherapy but not yet started

Exclusion Criteria:

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
* Patients with inadequate German language skills
* Patients with physical or mental impairments that make it impossible to perform the training programs or study procedures
Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA

The specific aim of this proposed study is to conduct a prospective RSA clinical study at Massachusetts General Hospital involving 50 patients receiving primary total hip replacements. All patients will receive the vitamin E treated polyethylene acetabular inserts. Short-term femoral head penetration and long-term steady state wear of the polyethylene will be measured using both RSA and Martell analysis techniques. Stability of the acetabular and femoral components will be measured in all patients using RSA analysis. The stability of the cemented femoral stems will be compared to the stability of the cementless femoral components as well as to historic data in the literature. In addition, all patients will complete a self-administered questionnaire to assess the clinical outcome of the surgery and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 20 to 75 years of age
* Subjects requiring primary total hip replacement
* Subjects with diagnosis of osteoarthritis, avascular necrosis, or traumatic arthritis
* Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

Exclusion Criteria:

* Subjects with limited life span
* Subjects with difficulty in comprehending study protocol for any reason.
* Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.
* Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
* Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia
* Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.
* Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.

All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

Eligibility Criteria:
Inclusion Criteria:

* Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation.
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.
Optimal Exercise Training and Nutrition Supplementation in Older Men

As we age we tend to lose muscle mass and strength. These losses contribute to the increased incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of independence and reduced quality of life in the elderly. As the number of seniors increases worldwide, it is becoming more and more important to develop strategies to counteract this loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple lifestyle modifications are the most potent defense strategies. Exercises such as weight lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts of vigorous aerobic exercise interspersed with period of rest, are the most effective in promoting gains in muscle mass and strength. Additionally, components of foods like whey (a protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to independently increase strength. In this study, we are looking to determine how much we can increase muscle strength in older men who are put on an 12 week exercise training program that combines weight lifting and HIIT, and who consume a daily supplement that contains whey protein, creatine, calcium and vitamin D.

Please see other documentation.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary (no participation in a structured exercise training program in past 6 months)
* BMI between 18.5-30.0 kg/m2
* Weight stable for past 6 months
* Normal resting blood pressure, or stage I hypertension

Exclusion Criteria:

* Smoking
* Use of simvastatin or atorvastatin
* Use of non-steroidal anti-inflammatory drugs
* Injuries that prevent safe-participation in an exercise training program
* Prescription blood thinners
* Diabetes or other metabolic disorders
* Cardiac or gastro-intestinal problems
* Infectious disease or cancer
Fluid Status and Body Composition Analysis by Bioelectrical Impedance in Patients After Cardiac Surgery (FLUBIACS)

Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality

Hydration and fluid balance dynamics after cardiac surgery is complex and requires comprehensive knowledge of bluid balance dynamics. Surgical trauma, anaesthesia and use of cardiopulmonary bypass significantly influence postoperative fluid status. Deviations from normal values on the other hand can be related to increase in morbidity and mortality.

The purpose of this prospective observational clinical study is to assess fluid status using bioelectric impedance in patients undergoing cardiac surgery and to evaluate its impact on postoperative morbidity and mortality.

Eligibility Criteria:
Inclusion criteria

1. Elective cardiovascular surgery (on-pump or off-pump)
2. Age ≥ 18 years
3. ASA 3 or 4
4. Provided verbal and written informed consent

Exclusion criteria

1. Refusal to participate in the research
2. \< 18 years
3. Renal failure requiring replacement treatment with hemodialysis
4. Amputation of a limb
5. Pregnancy
6. Emergency Procedures
7. Reoperation
8. Pacemaker/implantable cardioverter-defibrillator
Postoperative Sedation After Cardiac Surgery

This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* consent for participation
* cardiac surgical procedure requiring postoperative sedation

Exclusion Criteria:

* pregnant women,
* neurological or muscular disorder
* high risk of revision surgery
* patients having required a redo operation if the postoperative period of sedation was less than 2 hours
Normal Polysomnography Values in Healthy Children and Adolescents in China

The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.

We plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. All of them will be invited to undergo an overnight polysomnography for at least 7h in Beijing Children's Sleep Center, meanwhile the parameters about sleep including EEG, electromyography, electrooculography, ECG, pulse oximetry arterial oxygen saturation (SpO2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal PCO2 (PETCO2) will be recorded.

Based on the data we hope to give recommendation of normal PSG parameters of Chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for Chinese children conditions.

Eligibility Criteria:
Inclusion Criteria:

1.3 to 14-year-old children 2.from the community of China 3.healty children

Exclusion Criteria:

1. children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.
2. children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.
3. children with history of upper respiratory tract infection nearly two weeks.
4. children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.
5. children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.
6. children with any medical or surgicaldiseases.
7. children who have to use use sedation to maintain sleep.
8. parents or child not understand the study or do not agree to take part in.
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of cadaveric kidney transplants
* Patients at risk of DGF defined as one or more of the following:

  * Donor age \> 55 years
  * Cold ischemic time (CIT) ≥ 24 hours but \< 40 hours
  * Second or subsequent renal transplantation

Exclusion Criteria:

* Patients who have received an investigational drug within 4 weeks of baseline period
* Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
* Patients with body mass index (BMI) \> 32 kg/m2

Other protocol-defined exclusion criteria may apply.
Application of the Visualization of Treatment Objective (VTO) Analyses in Fabricating Anterior Repositioning Splints

This study conducted a randomized controlled clinical trial to evaluate the effect of the the therapeutic position of the anterior repositioning splint determined by VTO analyse compared with traditional method for the treatment of the Anterior Disk Displacement with Reduction of the Temporomandibular Joint.

A randomised clinical trial was conducted with 20 patients diagnosed with ADDWR through RDC/TMD and they were randomly allocated into the group 1(traditional group):the therapeutic position of the ARS were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints;group2(digitial group): the therapeutic position of the ARS were determinded by the VTO analyse,first,the participants were constructed to take CBCT and MRI scans,the ideal therapeutic position of the ARS were located in which the temporomandibular joint space distribute well and the condylar recapture the disc,the dentist could determine the amount of condylar movement and performed VTO analyse by assessing the CBCT and MRI scans ,then it could easily realize the final condylar movements with the application of the dental articulator.

They were followed-up in the baseline,1 month,2 and 3 months after the inserted of the splints using the Craniomandibular Index (CMI) for temporomandibular joint function and PHQ-9,GAD-7 for psychological assessments,the tmj space and disc-condylar angle were measured through the CBCT and MRI scans,before and after ARS therapy.

Eligibility Criteria:
Inclusion Criteria:

* anterior disc displacement with reduction (ADDWR) confirmed by magnetic resonance imaging (MRI)
* Classified as ASA 1 or 2
* Willing to participate and sign a written informed consent form.

Exclusion Criteria:

* pregnant women
* heart pace disorders and epilepsy
A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing forms of MS
* Expanded Disability Status Scale (EDSS) 0-5.5
* Continuous treatment with MS DMT for a minimum of 6 months
* Fingolimod naive

Exclusion Criteria:

* Immune system diseases other than MS
* Active macular edema
* History of selected prior infections and criteria for immunizations
* History of selected immune system treatments and/or medications
* Selected cardiovascular, pulmonary, or hepatic conditions
* Selected abnormal laboratory values
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control


Eligibility Criteria:
Inclusion criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA)
2. Impaired hepatic function
3. Renal failure or renal impairment
4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening
Periodontopathogens of Periodontal Patients

Study the presence of periodontal pathogens in a Catalan population with periodontitis and evaluate the influence of an intervention measure on oral hygiene teaching (video)


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* periodontal disease (grade III and IV)
* gave their informed consent to participate in the study
* do not present associated medical pathology

Exclusion Criteria:

* Patients who do not wish to participate in the study
* Patients following active treatment with antibiotics or having received antibiotic treatment in the last seven days,
* Patients who wear braces.
Patient Registry to Evaluate the Real-world Safety of Ruconest®

This is a prospective, real-world, observational patient registry for patients with HAE who are receiving treatment with Ruconest for HAE.

See below.

Eligibility Criteria:
Inclusion Criteria:

1. Patient provides informed consent as documented on the Institutional Review Board (IRB) approved informed consent document (ICF). For patients aged between 13 and 17 years old, the method of consent with or without assent will be determined by the IRB.
2. Patient is male or female and at least 13 years of age at the time of providing consent / assent.
3. Patient has been prescribed Ruconest for HAE.

Exclusion Criteria:

1. Patient is receiving HAE therapy as part of a clinical trial.
Leptin Receptors in the Bariatric Surgical Population Within the University of Pittsburgh Medical System: A Cohort Study

Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical population compared with non obese controls. Additionally serum levels of leptin, ghrelin, motilin and PYY will be compared amongst the different BMI classes and a quality of life questionnaire completed by all participants.

The hypothesis is that obese individuals have lower leptin receptors in enterocytes which is partially responsible for the higher serum leptin levels without appropriate control of satiety.


Eligibility Criteria:
Inclusion Criteria:

* Endoscopic Intervention

Exclusion Criteria:

* 18 years of age or older
* No acute GI bleeding
The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate

Water exchange method has been shown to reduce medication requirement and pain experienced during colonoscopy. It may increase the adenoma detection rate (ADR). Water exchange provides salvage cleansing and the refractive index of water (n equals about 1.3) is larger than that of air, which creates optical distortion that likely contributes to objects appearing larger underwater, making smaller lesions easier to visualize and it may help draw attention to those smaller lesions during withdraw. These principles facilitate to the higher adenoma detection rate.

There is a large number of literature on the adenoma detection rate during water exchange colonoscopy, but most studies have been conducted in only one centre, simple-size, and under sedation patients, the influence of adenoma detection rate under unsedation patients was unclear.

The aim of this study is to compare the ADR of colonoscopy by using the water exchange method versus the conventional air method in unsedation patients in multiple centers in China.


Eligibility Criteria:
Inclusion Criteria:

* age 18-80 patients with intact colon and rectum

Exclusion Criteria:

* prior finding of severe colorectal stricture;
* solid fetus contained in the last stool before colonoscopy
* no bowel preparation or cleansed by enema/lavage
* without the requirement of reaching cecum
* known colorectal polyps or polyposis syndrome without complete removal previously
* pregnant women
* hemodynamically unstable
* patients who cannot give informed consent
DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer

This early phase I trial studies how well dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and technetium-Tc99m sestamibi molecular breast imaging (MBI) work in assessing tumor response to chemotherapy in patients with triple negative breast cancer (TNBC) who are undergoing chemotherapy. Investigational imaging scans such as MBI and DCE-MRI may help researchers predict which patients may respond to treatment.

PRIMARY OBJECTIVES:

I. To determine the predictive value of advanced imaging modalities Tc99m sestamibi (technetium Tc-99m sestamibi) molecular breast imaging (MBI) and dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) for neoadjuvant chemotherapy (NAC) response in triple negative breast cancer (TNBC).

SECONDARY OBJECTIVES:

I. To evaluate and compare the ability all imaging modalities including standard of care digital mammogram (DM) and ultrasound (US) as well as novel modalities DCE-MRI and MBI to assess and predict response to neoadjuvant chemotherapy (NAC) in patients with triple negative breast cancer (TNBC).

EXPLORATORY OBJECTIVES:

I. To determine effect of molecular subtype of TNBC on diagnostic performance of different types of imaging modalities in predicting treatment response.

II. To determine the Utility of Dynamic Tc99m sestamibi MBI and DCE-MRI together with molecular profiling to identify a subgroup of chemoresistant TNBC patients.

OUTLINE:

Patients undergo DCE-MRI over 45-60 minutes. Patients receive technetium Tc-99m sestamibi via injection, and after 5 minutes patients undergo MBI scan over 1 hour. Both DCE-MRI and MBI are performed at the time of enrollment, at the end of anthracycline therapy, and at the conclusion of NAC before surgery. All patients also undergo standard of care imaging with DM and US (at the same time points if the treating doctor chooses to do so).

Eligibility Criteria:
Inclusion Criteria:

* The patient has proven TNBC, defined by standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (\< 10% tumor staining) and negative for human epidermal growth factor 2 (HER2) (immunohistochemistry \[IHC\] score \< 3, gene copy number not amplified)
* TNBC patients who are previously untreated and enrolled in the prospective Institutional Review Board (IRB) approved clinical trial: 2014-0185
* Patients who are able to understand and give consent to participating in the study

Exclusion Criteria:

* Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
* Has lesions involving chest wall
* Has known allergy to Tc99m sestamibi
* Has known contraindications to MRI
* Has contraindication to MRI contrast