cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety.

Background: Literatures have shown that patitents with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patitents' outcome is still unclear.

Patients and methods: In this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are cT3N2/N3M0, cT4aN+M0 and cT4bNanyM0, aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy (Capecitabine 1000mg/m2, BID, D1-14; Oxaliplatin 130mg/m2 on day 1 for a 21-day cycle) or neoadjuvant chemotherapy alone using XELOX regimen following by D2 gastrectomy and adjuvant chemotherapy with same dosage of XELOX therapy for up to 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

Eligibility Criteria:
Inclusion Criteria:

* informed consensus of the enrolled patients
* being able to receive oral drug
* from 18 to 75 years old
* proven to be primary adenocarcinoma of gastric cancer and pre-operative staging cT3N2/N3M0, cT4aN+M0, cT4bNanyM0,
* no prior other chemotherapy and/or radiation against the disease
* normal function of all other vital organs including heart,liver ,kidney and so on
* Eastern Cooperative Oncology Group performance status: 0\~2

Exclusion Criteria:

* history of other malignancy
* allergic reaction to capecitabine or oxaliplatin
* enrolled in other clinical trials
* abnormal GI tract function
* dysfunction of other organs
* pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
* other situations judged as not adaptive to the study by investigators
Identification the Expression of Sox2 in Colorectal Cancer Tissues

Sox2 has been studied in several types of human solid tumors. The investigators found that Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal tissues. So the investigators assumed that whether Sox2 plays an important role in the progression and migration of colon cancer.

In our study, we examined Sox2 expression in archived human colon cancer tissues and found that its Sox2 expression correlates with reduced patient survival, increased tumor grade and metastasis probability.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colorectal cancer

Exclusion Criteria:

* Clinical diagnosis characteristics not exactly described in the patients information
Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.

In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG).

In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting. The effectiveness of these 3 different commercially available agents containing flurbiprofen, hyaluronic acid, and hypochlorous acid, after use 2., 4.7. and on the 14th day, wound healing and pain perception was compared with the control group. primary observation was obtained by visual analog scale, wound healing index, bleeding of tissue, color match, and amount of painkiller used by the patient were also recorded

Eligibility Criteria:
Inclusion Criteria:- Patients with systematic conditions are classified as The American Society of Anesthesiologists Class I

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Exclusion Criteria:

* Pregnancy, lactation, and taking contraceptive pills.
* Oversensitivity or anaphylactic reactions which contraindicate the intervention.
* Orofacial neurological symptoms.
* Infections at operation zone.
* Psychotropic medicine, sedative, or non-steroid anti-inflammatory drugs use which can alter the sense of pain.
* Pathological mental conditions (dementia, psychosis) and lack of cooperation.
* Smoking
* Excessive gag reflex
* Operations are carried out with conscious sedation.
* Patients who do not want to sign consent.
Efficacy and Safety of Biphasic Insulin Aspart 30 for the Treatment of Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects from hospitals or clinics, diagnosed with type 2 diabetes mellitus
Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers

OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers.

II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients.

III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive arginine butyrate IV over 6-9 hours at night 5 days a week for 12 weeks, plus concurrent standard local therapy consisting of cleaning, saline irrigation, and dressing changes as prescribed by each patient's physician. Patients who experience progressive healing receive arginine butyrate 3-4 times a week. Arginine butyrate treatment may be discontinued and reinstated following a single 2 week medical complication.

Arm II: Patients receive standard local therapy alone for 12 weeks. Patients randomized to arm II may cross over to receive arginine butyrate if no or less than 25% healing is observed after 12 weeks.

Patients whose ulcers have closed by at least 15% per cycle may receive 2 additional 8-week cycles of arginine butyrate therapy and are followed for 2 months after healing is completed.

Eligibility Criteria:
PROTOCOL CRITERIA

INCLUSION:

--Disease Characteristics-- Significant sickle cell syndrome including Hemoglobin SS (HbSS), Hemoglobin S-beta thalassemia, and hemoglobin variants. Lower extremity or ankle ulcer (or ulcers) present for at least 6 months without healing --Patient Characteristics-- Age: 16-60 yrs Performance status: Not specified Hematopoietic: Not specified Hepatic: No hepatic compromise Transaminases no greater than 250 IU Renal: No renal compromise Creatinine no greater than 1.2 mg/mL (adults) Creatinine no greater than 0.9 mg/mL (teenagers) Other: Not pregnant Fertile patients must use effective contraception No poorly controlled seizure disorders No other secondary conditions that might inhibit immune function

* Prior/Concurrent Therapy Other: Must be treated with antibiotics prior to entry for complicating cellulitis or secondary infections

EXCLUSION :

--Prior/Concurrent Therapy-- Biologic therapy: chronic transfusion therapy Chemotherapy: prior or concurrent cancer chemotherapy concurrent butyrate derivatives Endocrine therapy: concurrent corticosteroid therapy Radiotherapy: Not specified Surgery: Not specified --Patient Characteristics-- Hepatic: hepatic compromise Transaminases greater than 250 IU Renal: renal compromise Creatinine greater than 1.2 mg/mL (adults) Creatinine greater than 0.9 mg/mL (teenagers) Other: pregnant; Fertile patients with no effective contraception Poorly controlled seizure disorders other secondary conditions that might inhibit immune function
Self-Compassion and Acute Pain

Research on self-compassion suggests its impact in the context of pain. In the current study, the investigators evaluate a short self-compassion intervention for coping with acute pain.

Self-compassion comprises three components: self-kindness, common humanity and mindfulness. Empirical evidence shows the relevance of self-compassion in the context of negative emotions such as depression, anxiety and anger. Research on chronic pain is promising yet limited. Self-compassion is associated with better pain-coping, pain-acceptance and quality of life, as well as reduced pain-related disability and burdening emotions. Experimental investigations on induced pain are missing. The aim of the current study is to evaluate a short self-compassion intervention for pain.

First, a heat stimulus is induced to all participants which is to be tolerated as long as possible and evaluated in intensity and unpleasantness. Next, participants receive a coping-strategy which they are randomly assigned to. Three different strategies are evaluated: (1) self-compassion, treating oneself with kindness while being mindfully aware of the painful stimulus, (2) acceptance, accepting the painful stimulus as well as pain-related thoughts, not trying to change, (3) distraction, distracting oneself from the painful stimulus and trying not to perceive the pain or painful thoughts. Participants practice the strategy with the painful heat stimulus three times. Then, they receive another heat stimulus which is to be tolerated as long as possible and evaluated. During the next week, participants obtain daily practices via e-mail for further fostering of the learned strategy. Finally, participants receive, tolerate and evaluate pain again in the laboratory.

Eligibility Criteria:
Inclusion Criteria:

* sufficient german language knowledge
* at least 18 years old

Exclusion Criteria:

* acute or chronic pain conditions
* drug or pain-medication (last 24 hours)
* Raynaud's disease
* high blood pressure
* neuropathy, coronary diseases
* diabetes, current alcohol
* studying psychology longer than two years
Piloting JUN_Pregnancy Mobile Medical App

This research activity looks at the safety of an investigational intervention, a mobile health (mHealth) app called JUN, that uses artificial intelligence (AI) to track symptoms and give time-sensitive feedback to pregnant women.

JUN is an intervention being developed to provide education and assist with decision making during pregnancy.

The researchers hope to learn differences in how effectively the participant use of the app is amongst women with and without criminal justice oversight such as adult probation or parole.

In this proposed pilot study, the investigators will use mixed methods to examine differences across three months among pregnant women. Sampling will be within three ethnically and geographically diverse sites, Texas, Oregon, and Minnesota to determine if there are differences in self-efficacy amongst pregnant women on Community Service (CS) compared to pregnant women without criminal justice oversight.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant female 18-50 years
2. Within first 6 months of pregnancy
3. Either on community supervision or without criminal system involvement
4. Located in Texas, Minnesota or Oregon

Exclusion Criteria:

1. Individuals who do not identify as women
2. Later pregnancy, beyond the first 6 months
PK/PD of Ertapenem In Patients With TB

Rationale:

Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. New, more effective drugs with less side effects are therefore urgently needed to solve this problem. Although several new drugs against TB are in the pipeline, physicians currently have limited treatment options for treatment of complicated MDR/XDR-TB cases. Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB.

Objective:

The main objective of this prospective clinical trial is to evaluate pharmacokinetics of a standard dose (2000mg) of ertapenem in TB patients. This clinical trial will provide important information on PK of ertapenem in TB patients for future studies. Data can be used for limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients.

Study design:

A prospective pharmacokinetic study.

Study population: 12 TB patients.

Intervention: Single dose of 2000mg in a 30 minutes intravenous infusion.

Main study parameters/endpoints:

The pharmacokinetic parameters (Vd, Cl, AUC, etc) of ertapenem are the primary endpoints of the study. The T\>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most likely the best predictive parameters for efficacy of ertapenem treatment and will be calculated for a range of M tuberculosis isolates.


Eligibility Criteria:
Inclusion Criteria:

* Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture and / or molecular test
* Adults: from 18 years until 64 years of age

Exclusion Criteria:

-Contra-indications for ertapenem:

* There are few adverse effects of ertapenem. The only absolute contra- indication is a previous anaphylactic reaction to ertapenem or other β-lactam antibiotic.
* Renal Insufficiency, defined by a eGFR of 30ml/min
* Pregnancy
* HIV
* Body weight \< 40 kg
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent form
* Males and female of non-child bearing potential patients aged 18 to 80 years
* Patients with neuropathic pain due to painful diabetic polyneuropathy.

Exclusion Criteria:

* Other pain that may confound assessment of neuropathic pain
* History of treatment failure with more than three adequate trials of medication for neuropathic pain
* Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy

Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. The most frequently affected joints are the knees, ankles and elbows.

The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints.

We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023.

The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method.

All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2).

Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient\&#39;s quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient\&#39;s alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of severe haemophilia A or B;
* age ≥ 6 years and ≤ 50 years;
* presence of hindfoot and/or arch misalignment;
* prophylaxis with factor deficient (VIII or IX).

Exclusion Criteria:

* patients with prosthetic implants/synthetic means
* uncooperative patients
Utility of CC7 Transfer in Stroke Subtypes

The purpose of this study is to evaluate the limb functional improvement after contralateral C7 root transfer in stroke patients.

Spastic limb paresis after stroke is a cause of long-term disability and reduction is quality of life, with loss of hand dexterity being especially prohibitive. In the recovery phase after initial injury, neural reorganization occurs and has been observed in both ipsilateral and contralateral hemispheres. Previous studies have identified contralesional (opposite to the side of the injury), in other words, ipsilateral, activation in the recovery of paretic hand function. However, this pathway of recovery is limited due to sparse connections between the ipsilateral hemisphere and the affected arm/hand. By establishing an anatomic connection between the ipsilateral hemisphere and the paretic arm with contralateral nerve transfer, compensatory capacity of the ipsilateral hemisphere is facilitated. This cross neck C7-C7 root transfer is an established procedure for the treatment of brachial plexus injuries and recently, for the treatment of spastic arm paresis in those with cerebral injury.

Eligibility Criteria:
Inclusion Criteria:

* History of ischemic or hemorrhagic stroke with resultant arm paresis that has ceased to improve within 1-5 years of rehabilitation.

Exclusion Criteria:

* pregnancy
Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.

Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.


Eligibility Criteria:
Inclusion Criteria:

* patients treated by CPAP for Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

* Central Apnea Syndrome
* Central Hypersomnia
Short vs Standard Implants in Maxilla

The prosthetic treatment with dental implants is challenging in posterior maxilla, where there is a sinus pneumatization. For the rehabilitation of patients with intermediate bone level, short implants have been used as alternative. It is also needed to look for the prosthetic context of rehabilitation with implants, like the use of different materials as abutments. The aim of this study is to compare the survival of two sizes of implants (short vs standard) placed in upper premolars region with need of bone graft, with a minimum of three years of follow-up, and assess the behavior of different abutments (titanium vs zirconia) in prosthesis in this context. This will be a randomized clinical trial with two groups: 1) standard implants and sinus lift; and 2) short implants without sinus lift. The patients who fulfill the inclusion criteria and accept to participate of this study, will be included in the randomization process. At the implant installation, a brown envelope, with the word SHORT or STANDARD, will be open, in order to determine the group. Abutment type will be also randomized. Four months after the installation, torque will be confirmed and the abutment will be installed. Implant failure and prosthesis failure in function of the abutment will be the outcomes. Data analysis will be conducted following a previously established spreadsheet using the Kaplan-Meier method and log rank test for success and survival, followed by Cox regression, if possible and according to the number of failures.


Eligibility Criteria:
Inclusion Criteria:

* good general and dental health;
* minimum of 6 mm bone width (BP);
* bone height in sinus region between 5 and 9 mm;
* bilateral posterior occlusal contact.

Exclusion Criteria:

* removable or partial denture;
* patient with systemic disease treatment in course;
* pregnant women;
* recent extraction at the site to receive the implant.
Longitudinal Advanced Prostate Cancer Cohort (LAPCC)

This study examines information from patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). By collecting biological samples (like blood, urine, and tissue), and health information (such as treatment, diet, and quality of life) researchers hope to learn more about prostate cancer and ways to improve outcomes in the future.

PRIMARY OBJECTIVE:

I. To create an annotated biorepository with prospectively collected blood and urine samples from men with advanced prostate cancer.

OUTLINE: This is an observational study.

Patients undergo blood and urine sample collection, complete surveys, and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* \* Men of all racial and ethnic groups 18 years of age or older

  * Men with a diagnosis of advanced (metastatic) prostate cancer who are scheduled to begin a new systemic treatment (including first or subsequent lines of therapy)
  * Prior participation on clinical trials is allowed

Exclusion Criteria:

* \* Inability to give informed consent
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.
* Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.

Exclusion Criteria:

• Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.