cyrilzakka/clinical-trials huggingface dataset:
Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer

In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.

A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against gastrointestinal carcinoma. In this study, the relationship between activity of DPD in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age ≧18;
* Histologically or cytologically confirmed gastrointestinal cancer；
* ECOG ≦2;
* Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
* Life expectancy of at least three months;
* Written informed consent to participate in the trial;

Exclusion Criteria:

* History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
* Inadequate hematopoietic function which is defined as below:

  * white blood cell (WBC) less than 3,500/mm\^3
  * absolute neutrophil count (ANC) less than 1,500/mm\^3
  * platelets less than 80,000/mm\^3
* Inadequate hepatic or renal function which is defined as below:

  * serum bilirubin greater than 1.5 times the upper limit of normal range
  * alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
  * greater than 2.5 times the ULN if no demonstrable liver metastases or
  * greater than 5 times the ULN in the presence of liver metastases
  * blood creatinine level greater than 2 times ULN
* Presence of peripheral neuropathy;
* Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
* Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male);
* Psychiatric disorder or symptom that makes participation of the patient difficult;
* Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months;
* Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes;
* Known DPD deficiency;
* Receiving a concomitant treatment with sorivudine or Brivudine within two months;
Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapy

Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in elderly patients receiving moderate emetogenic chemotherapy

The purpose of this trial is to determine if the dose of dexamethasone used as an antiemetic drug in patients with advanced cancer could be safely reduced.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed colorectal cancer patients with curative resection
* ECOG performance status 0-2
* Provision of signed, written and dated informed consent prior to any study specific procedures
* Receiving adjuvant chemotherapy with FOLFOX (5-FU, leucovorin, oxaliplatin) regimen

Exclusion Criteria:

* Having contraindication to dexamethasone
* Having nausea or vomiting before the start of adjuvant chemotherapy
Nutrition Thinking® Trial

The purpose of this study is to scientifically validate Nutrition Thinking®, a novel nutritional approach based on the values and methodologies of Design Thinking.

The concept of nutrition has changed exponentially in recent decades to include a range of challenges that were not foreseen. The strength of this movement is based on the understanding of (1) the complexity with which people face their nutritional challenges; and (2) the interconnection between food systems and overlapping health risks associated with malnutrition, obesity, and climate change.

Maintaining an adequate weight, a healthy and sustainable diet pattern are complex well-established challenges. However, current nutritional approaches to lose weight, based on functional experiences, often fail to promote long-term adherence to dietary recommendations and maintaining lost weight.

The ambiguity and complexity that involves an interactional nutrition, based on the experiences involved in how people act at the individual level and their relationships with the environment and dynamic systems, brings up the challenge of designing meaningful learning experiences to promote a change of culture and positive impact.

Current social changes demand the search for novel nutritional approaches based on methodologies that result in meaningful experiences. We need new ways to build diets that balance the needs of individuals and society as a whole, new ideas that address global challenges, new strategies that result in differences that matter, and a sense of purpose that includes everyone involved.

With that in mind, Nutrition Thinking® arises as a nutritional approach based on the values and methodologies of Design Thinking, an abstraction of a mental model for addressing complex problems and conducting projects based on empathy, collaboration, and experimentation. Therefore, Nutrition Thinking® represents a new nutrition learning matrix based on experience for the co-creation of authentic and sustainable diets.

Eligibility Criteria:
Inclusion Criteria:

* age between 25 and 35 years old of both sexes;
* nutritional diagnosis of overweight (BMI between 25-29.9 kg/m2);
* available to participate in the sessions proposed by the protocol (every 15 days for a period of 3 months).

Exclusion Criteria:

* presence of characteristics that make nutritional assessment impossible (eg. presence of metallic prostheses or amputated limbs);
* previous involvement in any clinical trial, nutritional or medical intervention for weight loss in the 6 months prior to recruitment;
* previous history of eating disorders (anorexia, bulimia, binge eating);
* presence of congenital diseases;
* presence of thyroid disease, hypertension, dyslipidemia and diabetes, defined through medical diagnosis associated with drug treatment and / or previous or current cardiovascular disease;
* pregnant or lactating women.
CentriMag Failure-to-Wean Post Approval Study

The primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject \>18 years of age
* Subject or legal representative has signed Informed Consent Form (ICF)
* Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from Cardiopulmonary Bypass

Exclusion Criteria:

• Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Lentiviral Gene Therapy for CGD

This is a Phase I/II clinical trial of gene therapy for treating Chronic Granulomatous Disease using a high-safety, high-efficiency, self-inactivating lentiviral vector TYF to functionally correct the defective gene. The objectives are to evaluate the safety and efficacy of the TYF-CGD gene transfer clinical protocol.

Chronic granulomatous disease (CGD) is a rare disorder caused by inherited defects in the NADPH oxidase multienzyme complex. It is associated with severe and life-threatening bacterial and fungal infections. Approximately two-thirds of all CGD cases result from mutations within the X-linked gp91phox gene (CYBB), followed by the autosomal recessive forms of CGD, with defects in the gene coding for p47phox (NCF1) accounting for 10-30% of all CGD cases.

The primary objectives are to evaluate the safety of the advanced self-inactivating lentiviral vector TYF-CYBB and TYF-NCF1, the ex-vivo gene transfer clinical protocol and the efficacy of immune reconstitution in patients overcoming frequent infections present at the time of treatment, assessment of vector integration sites, and finally the long-term correction of immune dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

1. CGD patients \>= 0 years of age
2. Molecular diagnosis confirmed by DNA sequencing and supported by laboratory evidence for absent or significantly reduced biochemical activities of the NADPH-oxidase
3. Karnofsky-Index \> =70%
4. At least one prior, ongoing or refractory severe infection and/or inflammatory complications requiring hospitalization despite drug intervention
5. Written informed consent for adult patient, and assent for pediatric subjects seven years or older

Exclusion Criteria:

1. Contraindication for leukapheresis (anaemia Hb \<8g/dl, cardiovascular instability, severe coagulopathy) or for administration of conditioning medication
2. Female patients who are pregnant or lactating as determined by history and/or positive pregnancy test
Embryonal Tumors of Infancy & Childhood: South Egypt Cancer Institute Experience

The aim of this study is to investigate demographic \& disease characteristics of pediatric cancer patients diagnosed with one of embryonal tumors to identify the prevalence, the spectrum of these disease entities \& treatment outcomes in these patients.

Background:

Embryonal tumors arise from cells that are normally present in the developing embryo and originate in developing tissues and organ systems. These tumors occur almost exclusively in children, and are usually diagnosed in children before age 5 years.

The group is heterogeneous and includes relatively common pediatric tumors as well as rare tumors. Three common types of embryonal tumors in children are neuroblastoma, Wilms tumor (WT), and retinoblastoma. Other embryonal tumors, include medulloblastoma and rhabdomyosarcoma.

Patients \& Methods:

From January 2001 to December 2015, retrieval \& analysis of the medical records of pediatric patients with embryonal tumors will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age less than or equal to 18 years.
* Patients diagnosed with any of embryonal neoplasms.

Exclusion Criteria:

• Patients whose age more than 18 years.
Alendronate and/or Parathyroid Hormone for Osteoporosis

This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.

This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).

Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.

Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.

During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar spine or hip BMD T-score less than or equal to minus 2.0
* Postmenopausal at least 5 years
* Fully ambulatory
* Able to give informed consent

Exclusion Criteria:

* No concurrent illnesses that cause bone loss
* No recent drug treatment for osteoporosis
* No recent fracture
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection
* Body mass index (BMI) ≥ 18 kg/m\^2
* HCV RNA ≥ 10000 IU/mL at screening
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
* Must not have cirrhosis

Exclusion Criteria:

* Current or prior history of clinically significant illness other than HCV
* Screening ECG with clinically significant abnormalities
* Prior exposure to HCV specific direct acting antiviral agent
* Prior treatment of HCV with interferon or ribavirin
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of non-HCV etiology
* Hepatitis B
* Active drug abuse
* Use of any prohibited concomitant medications
TMS-evoked Potentials During Heat Pain

This study investigates the modification of the local-to-global connectivity pattern in response to experimental heat pain. Transcranial magnetic stimulation (TMS) will be applied to elicit electroencephalography (EEG) responses in healthy volunteers. The TMS-evoked potentials (TEPs) will be recorded and serve as a reflection of cortical reactivity to TMS. A thermal cutaneous heat stimulus will induce painful sensations.

Abnormal connectivity patterns interfere with the normal function of a given neuronal network, thus leading to circuit dysfunction and, subsequently, chronic pain. In the last few years, neuroscience has been heavily influenced by network science. This synergistic association provided a new framework for understanding brain function in health and how dysfunction in specific neuronal brain circuits can lead to symptoms. A network comprises nodes (e.g., areas of the brain) and edges (functional connections between nodes). An effective network can process and share large amounts of information while maintaining specificity and not allowing noise to contaminate the flow of information across the circuits. The network approach to brain functioning has been able to integrate what has been known for several decades as spatial structural anatomy with the time-varying streaming of information (connectivity) in a dynamic perspective. In this context, symptoms of diseases are seen as being correlated with specific network abnormalities, and therapeutic interventions as being associated with the normalisation of these abnormal patterns of connection. This study will investigate the responses of specific neuronal brain circuits to experimental heat pain in healthy volunteers. It has been hypothesised that the local-to-global connectivity pattern obtained by the stimulation of different cortical hubs (e.g., the primary motor and dorsolateral prefrontal cortices) will be described by TMS-EEG responses in healthy individuals, and the modification in cortical connectivity in experimental models will be described and compared it with a non-painful sensory stimulation of the same salience.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Speak and understand English

Exclusion Criteria:

* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* History of chronic pain or current acute pain
* Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
* Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 5

The purpose of this study is to examine whether providing additional intervention support to individuals with lower than expected weight loss within the initial stages of an internet-based behavioral weight loss program improves weight loss outcomes at Week 12, compared to the internet program alone.


Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years
* BMI \>=25 kg/m2
* No health problems that make weight loss or unsupervised exercise unsafe
* English speaking
* Access to computer/internet

Exclusion Criteria:

* report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire 62 (PAR-Q; items 1-4).
* Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written consent to participate from a health care provider
* are currently pregnant or intend to become pregnant in the next 12 months
* are planning to move outside of the state within the next 4 months
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility Criteria:
Inclusion Criteria:

* unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day.
* taking \>/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

* receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
* scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.
Influence of Lateral Pressure on Sectional Matrix

The aim of this study was evaluating the clinical effectiveness of the hand instrument in conjunction with sectional matrix when applying lateral forces at the contact area during curing to achieve large and tight proximal contacts in posterior teeth.

Dental caries is considered as one of the most prevalent oral infections. Initiation of dental caries is a mufti-factorial process, its risk factors includes high loads of cariogenic bacteria, increased frequency of sugar intake, insufficient exposure to fluoride and reduced salivary flow. Other factors that may influence the occurrence of caries include poor oral hygiene and socio-economic status.

Inter-proximal caries lesions develop between the contacting proximal surfaces of two adjacent teeth. Massive evolution took place in restorative techniques, composite resin materials, cavity designs and armamentarium in the past few decades. As well as drastic solutions for earlier problems of composite resins such as bonding to dentin, wear resistance, postoperative sensitivity and polymerization shrinkage. Despite all the progress noted in that area, still achieving proximal contact tightness in Class II resin composite restorations is considered one of the biggest challenges facing clinicians Proximal contact tightness is a physiological dynamic entity of multifactorial origin that is largely affected by tooth type, location, time of day, patient position, mastication and restorative procedures Failure to obtain proper proximal contact area will influence stability of dental arch and transmission of forces along long axis of teeth during mastication. Traumatic masticatory forces can lead to various problems like; rotation and displacement of the teeth, lifting forces on the teeth, deflective occlusal contacts and food impactions that would result in trauma, pain, inflammation and bleeding of the periodontium. The contact must be neither open nor too tight.

Aim of this study was evaluating the clinical effectiveness of the Optra Contact in conjunction with sectional matrix when applying lateral forces at the contact area during curing to achieve large and tight proximal contacts in posterior teeth.

Eligibility Criteria:
Inclusion Criteria:

* Patients having posterior class II carious lesions were included
* Absence of pain from the tooth to be restored
* Good general health
* Age range:18-50 years
* Fully erupted occluding teeth

Exclusion Criteria:

* Diastema between posterior teeth
* Presence of fixed partial dentures
* Severe periodontal diseases Tooth mobility Non vital teeth