cyrilzakka/clinical-trials huggingface dataset:
Alcohol Research Consortium in HIV-Intervention Research Arm

Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms.

Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes.

Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions

Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Hypothesis 1A: Patients who are treated using algorithm-guided alcohol treatment will decrease drinking quantity and or frequency compared to pre-algorithm levels. Hypothesis 1B. Patients who are treated using algorithm-guided treatment will decrease current AUD symptoms compared to pre-algorithm symptoms levels.

Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Hypothesis 2A. Patients treated using algorithm-guided treatment will increase adherence to clinic visits and HIV medications compared to pre-algorithm levels. Hypothesis 2B. Patients who receive algorithm-guided treatment will have improved HIV biomarkers (e.g., CD4 and VL). Hypothesis 3B. There will be a positive relationship between VL and alcohol consumption measured by self-report and PEth level.

Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions (e.g., depression, anxiety, HCV, other drug use disorders). Hypothesis 3A: Persons living with HIV (PLWH) with co-morbid depression and anxiety receiving algorithm-guided treatment will have better alcohol, mental health and HIV treatment outcomes compared to similar individuals in SC. Hypothesis 3B: PLWH with comorbid HCV receiving algorithm-guided treatment will have improved FIB4 results and reduced likelihood of HCV recurrence compared to persons in SC. Hypothesis 3C: Other drug use will decrease among those receiving algorithm-guided treatment vs SC.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years or older;
* Receiving HIV care at the UAB, UW or UCSD clinics and not anticipating changing clinics over the next 12 months;
* AUDIT-C score \> 3 women or \> 4 men at time of PRO.

Exclusion Criteria:

* Non-English speaking;
* Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.
Effect of Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer

To determine progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer in relation to age, BMI and tumor sidedness, describing their predictive influence on systemic therapy outcome.

Colorectal cancer (CRC) represents a major public health concern as it is the third most frequently diagnosed cancer and the fourth cause of cancer-related mortality worldwide . The ﬁve-year survival rate is around 64.9% for all stages, while in metastatic cases, it only reaches 13.1% .

Approximately 26% of CRCs are diagnosed at stage IV among patients aged younger than 50 years, compared with 23% in those aged 50 to 64 years and 19% among those aged 65 years and older. Overall survival (OS) among patients younger than 50 years (68%) is similar to that in those 50 to 64 years (69%) because of a later stage at diagnosis.

Obesity is associated with an increased incidence of CRC . In recent studies body mass index (BMI) was prognostic for overall survival and progression free survival. That is risk of progression and/or death was greatest for low BMI; risk decreased as BMI increased. BMI was not predictive of treatment effect . Cachexia and associated poor performance status have previously been identiﬁed as negative prognostic factors in patients with CRC.

Tumor sidedness is an independent prognostic factor in patients with early and metastatic CRC as left-sided primaries have improved outcomes. sidedness also represents a powerful predictor of benefit from anti epidermal growth factor receptor\[EGFR\] inhibitors therapies in patients with RAS wild-type metastatic CRC (mCRC) .

The mainstay of treatment of mCRC includes cytotoxic chemotherapy with the addition of a molecularly targeted agent . The cytotoxic regimens that are usually used include a combination of oxaliplatin or irinotecan with a fluoropyrimidine, in addition to targeted agents such as \[EGFR\] inhibitors for patients with RAS wild-type mCRC or vascular endothelial growth factor inhibitors .

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Pathologically proven colon or rectal adenocarcinoma.
* Stage IV colorectal cancer.

Exclusion Criteria:

* Age \<18 years.
* Not pathologically proven colon or rectal adenocarcinoma.
* Stage I, II and III colorectal cancer.
Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers

Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause of cancer-related death worldwide. The incidence of HCC is rising in Europe and the United States and is expected to continue to increase during the next 2 to 3 decades. The expected survival rate is still decimal, especially in patients with advanced HCC. However, in recent years, several treatment methods for patients with advanced HCC, including antiangiogenic chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial chemoembolization, have been developed. Among these new treatment methods, concurrent chemoradiotherapy has also proved to increase patient's survival rate. It is important to predict treatment response before treatment or immediately after treatment because there are several other treatment options as mentioned above. Recently, there have been several reports that MR perfusion parameters such as Ktrans can predict treatment response in cervical cancer and colorectal cancer. Therefore the purpose of the investigators study is to evaluate the feasibility of predicting treatment response by MR perfusion, contrast enhanced ultrasound parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with advanced hepatocellular carcinoma who undertake concurrent chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have advanced hepatocellular carcinoma and plan to undertake concurrent chemoradiotherapy.
* Patients willing to undergo the study procedure
* Patients who are fully informed about the study and have signed the informed consent form

Exclusion Criteria:

* Patients (men or women) under 20 years of age
* Patients who have been received any other treatment including TACE, operation, TACI, systemic chemotherapy, intraarterial chemotherapy, antiangiogenic therapy
* Patients who have hypersensitivity to MR or US contrast agents
* Women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit
* Patients not eligible to contrast media injection according to product labeling
* Patients with a contraindication for MRI or CT
* Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis
STRIVE Post-Market Registry Study

This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.

This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States.

Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
2. Subjects must understand and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
3. Subjects who have incomplete screening or baseline data.
Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)

This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy.

The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).

Any patient seen by gastroenterologists working in the endoscopy unit and meeting the inclusion criteria may be recruited.

The patient will be offered to participate in the study. The information form as well as the consent, will be given to the patient for a good understanding of the study and the investigator in charge of the patient gives all the additional explanations necessary for this good understanding (but of the study, the course, risks and benefits).

A period of reflection will be left to the patient or his family to make a free decision whether or not to participate in the study.

After the consent to participate will be signed by the gastroenterologist and the patient, the patient will be randomized. The use of the Genius® system will depend on the randomization that will be performed at the start of the colonoscopy.

This randomization will be done in the computer examination room using the randomization software.

The patient will therefore be randomized into 2 groups:

Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system

A comparison of the two groups standard colonoscopy vs colonoscopy assisted by Genius® system will be made as following:

A-Main criterion:

- Adenoma detection rate (ADR)

B-Secondary criteria:

Polyps detection rate (PDR) Proximal serrated polyps detection rate (PSPDR) Neoplasia detection rate (NDR) Mean number of polyps (MNP) Mean number of adenomas (MNA) Factors associated with ADR

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for total colonoscopic exploration, during the period study
* Patient over or equal to 18 years
* ASA 1, ASA 2, ASA 3
* No participation in another clinical study
* Certificate of non opposition signed

Exclusion Criteria:

* Patient under 18 years old
* ASA 4, ASA 5
* Pregnant woman
* Patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, Platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
* Patient referred for resection of a known polyp
* Inflammatory bowel disease
* Known colonic stenosis
* Diverticulitis less than 6 weeks old
* Patient unable to give consent or protected by law
* Opposition expressed for inclusion in the study
Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.


Eligibility Criteria:
Inclusion Criteria:

* Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
* Evaluable or measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

* Uncontrolled Central Nervous System (CNS) metastasis.
* Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
* Concurrent malignancy
* Prior chemotherapy for NSCLC
* Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
* Superior vena cava syndrome contra-indicating hydration
* White Blood Cells (WBC) \< 3,000/mm³
* Absolute neutrophile count (ANC) \< 1,500/mm³
* Platelet \< 100,000/mm³
* Hemoglobin (Hgb) \< 9.0 g/dL
* Total bilirubin \> 1.5 x Upper limit of normal (ULN).
* Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 5.0 x ULN.
* Serum creatinine \>1.25 x ULN and calculated creatinine clearance \<60mL/min
Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population

The decline in physical function and strength was seen by the nature of aging. The older adults often complain of fatigue. For these reasons, proper rehabilitation approaches should be used to ensure healthy life and to keep the quality of life at the highest possible level by minimizing the decline seen with aging process. Exercise programs and Neuromuscular Electrical Stimulation (NMES) are applied in rehabilitation to restore muscular strength and improve physical performance. NMES is used to prevent the atrophy of nonuse, to increase joint range of motion, to re-educate muscle, to regulate spasticity, to replace orthosis, to improve motor involvement of muscle fibers. Despite the use of NMES for strengthening in the clinics, the application parameters and methods should be discussed. The frequency, the pulse duration, the on / off time, the amplitude, the waveform of the current and the application time vary between the studies. For geriatric populations, it is recommended that the highest intensity, biphasic symmetrical currents with a frequency in the range of 50-100 Hz, for 100-400 μs, can be pulsed for ideal amplification. NMES is usually practiced by physiotherapists continuously for 20 minutes in to strengthen. However, in recent studies, it has been shown that continuous application of a single-session 100 Hz current for 20 minutes leads to intense fatigue and after a while the effect of the strengthening of the current has been removed. Therefore, intermittent applications have been proposed instead of continuous applications for 20 minutes. Considering the fragility and the presence of sarcopenia in the geriatric population, NMES applications should be preferred in which rest periods are given instead of continuous application for 20 minutes. In the literature, there is no study showing the effect of NMES on Quadriceps strength, fatigue and physical function by using quadriceps stimulation for 20 minutes using different stimulation periods.Therefore, in this study, will be investigated the possible effects of two different methods of NMES on Quadriceps strength, fatigue and physical function.


Eligibility Criteria:
Inclusion Criteria includes

* age 60 years or older
* be able to climb one floor of stairs independently
* not participate in an exercise program to increase strength or physiotherapy programme.

Exclusion Criteria:

* having a medical condition in which NMES training is contraindicated
* having a cognitive impairment
* having implanted cardiac pacemaker
A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer

To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during the surgery after partial devascularisation (sample B) and stored for future genomic and proteonomic evaluations.

Three tumor samples will be obtained after the patient is under anaesthesia,

1. Prior to starting surgery (Sample A)
2. The middle intra-operative sample, which will be collected when half the tumour has been devascularized (i.e., somewhere midway during the surgery). (Sample B)
3. A third post excision (anoxic sample C). These tumour tissue samples will be stored as snap frozen, in RNA later and as paraffin sections.

To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during and stored for future genomic and proteonomic evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosis of breast cancer (by FNAC or Biopsy)
2. Not received any chemotherapy or surgical intervention except core biopsy.
3. Planed for Breast cancer surgery
4. Willing to give consent for the study

Exclusion Criteria:

1. Clinically diagnosis of Metastatic breast cancer
2. Received any anticancer therapy
Biodistribution of Neutrophile Proteases in the Sputum of Patients Affected by Cystic Fibrosis

The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue.

The respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results.

The identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.


Eligibility Criteria:
Inclusion Criteria:

* Man /woman older than 18 years (for adult and group)
* Child aged 6 to 18 years (for child group)
* Suffering from cystic fibrosis in stable condition, ie not having presented thrust acute attack of the broncho-pulmonary or hospitalization for treatment of his illness during the previous 2 weeks

Exclusion Criteria:

* colonized by Burkholderia cepacia ou Stenotrophomonas maltophilia
* non smoker (control group)
* Without history or respiratory respiratory disease known (control group)
* Antibiotic treatment and / or anti-inflammatory drug (NSAID or corticosteroids) in the 2 weeks prior to the inclusion in the study (control group)
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants born after a normal gestation period (\>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother.
* Written informed consent was obtained from the parent/guardian of the subject before study entry.

Exclusion Criteria:

* History of allergic disease/polio disease,
* Confirmed or suspected immunosuppressive or immunodeficient condition,
* Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
* Received treatment prohibited by the protocol.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Menstrual Health Education's Impact on Knowledge, Attitudes and Self Care Behavior of Dysmenorrheal Adolescents

This study will be a randomized controlled trial. This study will be conducted in F G modal for girls' I/8-4, Federal Government College for Women and Islamabad Model College for Girls. A sample size of 138 patients will be taken. Patients will be divided into two groups by lottery method. Group A will receive Educational sessions and informational pamphlet while Group B will only receive the pamphlets. Experimental group will receive for 4 sessions (2 per week). The outcome measures Menstrual Attitude Questionnaire (MAQ), Dysmenorrhoeic Knowledge Scale (DKS) and Dysmenorrhoeic Self-Care behavior Scale (DSCBS) will be measured at baseline, and at the end of week 2 and after 3 months. Data will be analyzed by SPSS 21.

Dysmenorrhea, characterized by painful cramps of the uterus during menstruation. It affects up to 95% of menstruating women. Dysmenorrhea is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea is defined as menstrual cramping pain that occurs immediately before or during menstruation in the absence of any pelvic pathology. The pain commonly starts within 3 years of menarche (the first menstrual period). Prevalence of primary dysmenorrhea varies from between 16 to 91% in reproductive aged women. Primary dysmenorrhea is the leading women hood problem that affects 90% of adolescent girls. Its prevalence decreases with increasing age in a large percentage of sufferers.

A study conducted in China concluded that nurse-managed education program improved adolescent girls' menstrual knowledge, promoted a more positive attitude, encouraged confidence, and improved pain relief practice. Another study conducted in Taiwan showed that the prevalence in dysmenorrhea in female adolescents was high, but they were lacking in dysmenorrhea related self-care knowledge. An Australian study concluded that the prevalence and impact of dysmenorrhea on Grade 11 and 12 girls is high, girls need more education on this area to prevent unnecessary suffering and interruption to school routine as they lack knowledge of and experience with effective treatment. A cross-sectional, internet-based survey was conducted, concluded that one in 3 women quit daily activities owing to menstrual symptoms. Half of all women did not mention menstrual complaints being the reason for transferring tasks in a family setting. However, considering the impact of menstrual symptoms on daily activities in a large group of women, it is time to open the societal dialogue and improve education for both patients and doctors.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent girls aged 13-19 years of age.
* Experienced dysmenorrhea cramps 2 or more times during the last 6 months.
* Dysmenorrhea diagnosed using working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score.

Exclusion Criteria:

* • Unwilling to participate.

  * Known cases of depression, anxiety, bipolar disorder, and other mood disorder
  * Minors whose parents do not allow.
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in Chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. This is a China alone study.


Eligibility Criteria:
Inclusion Criteria:

* Chinese patients
* Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints
* Active plaque psoriasis at screening
* Inadequate response to at least one conventional synthetic DMARD

Exclusion Criteria:

* Non-plaque forms of psoriasis (with exception of nail psoriasis)
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA