cyrilzakka/clinical-trials huggingface dataset:
Women in Dual With Dolutegravir

Strategies for optimizing antiretroviral treatment in virologically suppressed patients are still a major challenge in the field of HIV. These strategies include improving the toxicity and tolerability of drugs in the short and long term, such as replacing toxic agents with safer ones or reducing the number of drugs in the combination. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir (TFV) that is converted intracellularly to the active form, resulting in higher concentrations of TFV diphosphate in circulating lymphocytes than those obtained with tenofovir disoproxil fumarate (TDF). Because of these pharmacokinetic properties, TAF results in 91% lower plasma exposure to TFV. Phase 3 studies have established the virological noninferiority of TAF to TDF, with a lower frequency of renal and bone adverse events. Replacing TDF with TAF may be a safe and effective option to reduce toxicities when switching from one ARV strategy to another and, to date, could represent the optimization of a three-drug regimen. Dolutegravir (DTG) is a potent INSTI that exhibits rapid and potent viral load reduction and a high barrier to resistance.


Eligibility Criteria:
Inclusion Criteria:

* Female individuals
* HIV-1 documented infection
* Age \> 18 years
* Being on an effective (pVL \< 50 copies/ml) three-drug cART regimen containing tenofovir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TDF/F/PI/c; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) for at least 3 months before the screening. Two consecutive HIV-1 RNA determinations below the determination threshold before enrollment are required
* No known allergy or intolerance to NRTIs, NNRTIs or INSTIs
* Women of childbearing potential will be required to adopt an effective birth control system throughout the study period
* Subjects able to comply with the protocol requirements
* Informed consent signed

Exclusion Criteria:

* Having failed virologically any previous ART regimen · Evidence of any 3TC (presence of M184V/I or K65R/E/N) or INSTI resistance · Having ever been treated with mono or dual ARV therapies subsequently intensified to three-drug cART regimen
* Pregnancy or breast-feeding or not willing to use effective contraception if they are of child bearing potential
* An active malignancy or OI requiring active treatment (prophylactic regimens are allowed) · HBV infection · A life expectancy \< 2 years
Chromosomal Instability in Ovarian Cancer

Chromosomal instability (CIN) refers to the ongoing genomic change, which involves the amplification or deletion of chromosome copy number or structure. The changes rang from point mutation to small-scale genomic change and even the change of whole chromosome number. It has been reported that the characteristics of genomic rearrangement can be used as a marker of clinical outcome of high-grade serous ovarian cancer, and specific genomic rearrangement are related to the poor prognosis. In noninvasive gene detection with low coverage, patients diagnosed with ovarian cancer have deteriorating progression-free and overall survivals regardless of the tumor stage when somatic copy number distortion (sCNA) exceeds the threshold in plasma. The detection rate of sCNA increased along with the tumor stage. We enrolled those as our target patients, who are diagnosed with high-grade serous ovarian cancer and willing to take part in. The CIN in peripheral cell-free DNA was observed before initial treatment, after primary debulking or staging surgeries, before recurrence and during the process of recurrence treatment. Our aim is to explore the application of CIN in peripheral tumor DNA in the detection of minimal residual lesions (MRD) after primary treatment and recurrence monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed of primary ovarian high grade serous carcinoma (HGSC)
* Aged 18 years or older
* Acceptance of surgical treatment for HGSC
* With detailed follow-up outcomes

Exclusion Criteria:

* Not meeting all of the inclusion criteria
* Declining to anticipate the trial
MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

The purpose of this study is to determine the safety and effectiveness of an investigational drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
* Patient has a 6th grade reading level or better
* Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the study
* Patient has had a stable living arrangement for at least 3 months prior to study start
* Patient is in general good health based on screening assessments
* Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75 at screening and at the first baseline visit
* Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal to 4 at screening and at the first baseline visit

Exclusion Criteria:

* Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
* Patient has a history of head trauma with loss of consciousness greater than 15 minutes
* Patient has had warfarin treatment, MAO inhibitors, clonazepam or clozapine within 1 month of screening
* Patient has had ECT treatment within 6 months of screening
* Patient requires treatment with antihistamines or certain other medications listed in the protocol
* Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within the past 5 years
* Patient has a history of alcohol or drug dependence within the past year or alcohol or drug abuse within 3 months of screening
Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.

Exclusion Criteria:

* Patients requiring BPH surgery immediately or within the 12 following months:

  * Acute renal obstruction
  * Chronic renal obstruction
  * Chronic renal failure from BPH
  * Bladder stone
  * Recurrent urinary tract infection
  * Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
  * Hematuria from BPH
* Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
* Patients previously not improved by an alpha1-blocker treatment
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Combination with other alpha1-blockers
* Hepatic enzyme (SGOT or/and SGPT ) \> 1.5 Upper Normal Limit
* Unstable angina pectoris
* Severe concomitant condition threatening life.
* Patients who had failed treatment with finasteride (Proscar)
* Patients with neuropathic bladder.
* Patients with history of previous surgery for BPH
* Patients with high risk for prostate cancer based on the clinical judgement of the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Thromboprophylaxis in Critically Ill Patients

Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients.

It was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.

Background: The optimal dose regimen of low molecular weight heparins (LMWH) for thromboprophylaxis in critically ill patients is unknown.

Objectives: We performed a prospective, randomized study to determine anti-Xa activities following subcutaneous administration of 5000 IU or 7500 IU dalteparin for thromboprophylaxis in ICU patients compared with medical patients receiving the standard dose of 5000 IU.

Patients and Methods: Twenty-five ICU patients received 7500 IU (group 1) and 29 ICU patients received 5000 IU dalteparin subcutaneously (group 2) for thromboprophylaxis. Twenty-nine medical patients receiving 5000 IU dalteparin served as control group (group 3).

Eligibility Criteria:
Inclusion Criteria:

* Requirement for prophylactic anticoagulation, patient age ³19 years, creatinine clearance within normal range, prothrombin time \>30% and thrombocyte counts \>100 G/l.

Exclusion Criteria:

* Estimated time of admission less than 24 hours, full anticoagulation, renal failure, history of heparin-induced thrombocytopenia, hereditary or acquired coagulation disorders.
Effects of Excess Energy Intake on Metabolic Risk

The prevalence of obesity has reached epidemic proportions and is associated with the development of insulin resistance and type 2 diabetes (T2DM). A unifying theme has emerged over the past few years suggesting that lipid oversupply to metabolic organs responsible for glucose regulation leads to insulin resistance. Fitting with this, we and others have shown that increased lipid accumulation within skeletal muscle and/or liver is associated with impaired glucose uptake. However, the underlying mechanisms that mediate changes in muscle lipid metabolism are not yet known. The overall aim of this project is to examine metabolic effects of experimental weight gain in lean and overweight individuals with and without a genetic predisposition to type 2 diabetes. We hypothesise that lean subjects will increase fatty acid oxidation and upregulate mitochondrial oxidative capacity in muscle following overfeeding to protect against body weight gain and insulin resistance, but overweight subjects with a genetic predisposition to T2DM will have a defect in this ability.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary (\<60 min formal exercise per week)
* Aged 20-65 years

Exclusion Criteria:

* Personal history of diabetes, cardiovascular disease or hypertension
* Recent weight change (larger than 4kg in the past 3 months)
* Smoking
* Regular use of medications, except oral contraceptives
* Individuals with alcoholism or other substance abuse
* Pregnancy or lactation, women who are planning to become pregnant or who are not using adequate measures of birth control.
Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC

The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.

The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.

Eligibility Criteria:
Inclusion Criteria:

* untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system;
* at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1;
* 18-75 years of age;
* Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
* 10) FEV1\>1.0 L;
* suitable function of bone marrow, liver, kidney and coagulation

Exclusion Criteria:

history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses.

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Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function

The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.

The investigators will measure acute endothelial and vascular changes before and after a 30-minute Hookah smoking session in a controlled laboratory environment to: (1) Determine the acute effects of Hookah smoking on large-vessel endothelial vasodilator function measured by brachial artery flow mediated dilation; (2) Determine the acute effects of Hookah smoking on micro-vessel endothelial function as measured by reactive hyperemia peripheral arterial tonometry; (3) Determine the acute effects of Hookah smoking on pulse wave velocity and aortic pressure waveform measured by pulse tonometry.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 29 years of age
* Habitual Hookah smoker defined as having smoked Hookah \>=12 times in the past 12 months
* Have not smoked cigarettes within the past 12 months

Exclusion Criteria:

* History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease
* Exhaled carbon monoxide level \>10 ppm
* BP \< 140/90 mmHg
* BMI \<18.5 or \> 30 kg•m2
* Resting heart rate \> 100 beats/min
* Taking prescription medication
* History of illicit drug use
* Pregnant
REmote Symptom COllection to improVE postopeRative Care

There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.

Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.

Eligibility Criteria:
Inclusion criteria

1. At least 18 years old. Ages of subjects \>89 will simply be reported as \>90.
2. Scheduled for a GI surgery for management of a tumor in a participating hospital.
3. Fluent in oral and written English.
4. Has consistent and continued full access to an operational Wi-Fi for the duration of the study.

Exclusion criteria

1. Unable to provide informed consent.
2. Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.
3. Life expectancy of less than 60 days.
4. In the opinion of the investigator, participation in this study is contraindicated.
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy

Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary endpoint: virological success (HIV RNA \<50 copies/mL) in the first six months and at the end of the study.

Background: Either LPV/r or EFZ plus a two nucleoside reverse-transcriptase inhibitors (NRTIs) are recommended by the current guidelines all around the world as the main background drugs for initial therapy of human immunodeficiency virus type 1 (HIV-1) infection. This indication is based in results of clinical trials, but patients who participate in these studies usually are greatly motivated to continue their prescribed regimen, and can be different from the "real life". Therefore, clinical practice often cannot reproduce published results.

Methods: A retrospective longitudinal cohort study was performed with 36 naïve-treatment patients, who started therapy with LPV/r or EFZ, with follow-up of 36 months. The primary endpoint was virological success (HIV RNA \<50 copies/mL) in the first six months and at the end of the study. Effectiveness was examined comparing time to virological failure and CD4 recovery.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected naive-treatment patients

Exclusion Criteria:

* use of Anti-Retroviral Agents in the past
Human Care Model-Based Nursing Interventions on Psychosocial Adjustment

The aim of the randomized controlled interventional study was to to evaluate the effect of human care model-based nursing interventions on psychosocial adaptation in patients with cardioverter defibrillator. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered.

Aim: The aim of this research was to investigate the impact of nursing interventions that were Watson's Human Care Model- based nursing interventions on the psychosocial adjustment of patients who have undergone implantable cardioverter defibrillator (ICD) implantation.

Design: The present study employs a randomized controlled design with a pretest-posttest control group, conducted over a period spanning from March 2020 to July 2022.

Methods: The research was carried out utilizing an implantable cardioverter on individuals who met the inclusion criteria and provided consent to participate in the study at an adult cardiology outpatient unit located within a university hospital. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered. The data were gathered utilizing an introductory information form and the Psychosocial Adjustment to Illness-Self-Report Scale (PAIS-SR). The statistical methods employed in the data analysis included the chi-square test, t test for independent groups, Mann-Whitney U test, t test for dependent groups, and Wilcoxon signed-rank test.

Eligibility Criteria:
Inclusion Criteria:

* the patient must be of legal age
* the patient must have undergone ICD implantation at least one month prior
* the patient must possess the ability to comprehend and communicate in Turkish
* the patient must not exhibit any hearing or speech impairments
* the patient must not have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
* the patient must possess the capability to operate a computer, telephone, and internet

Exclusion Criteria:

* the patient is less than 18 years old
* the patient has hearing and speech problems
* the patient must have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
* the patient must not possess the capability to operate a computer, telephone, and internet
* the patient's refusal to participate in the study
Duration of Spinal Manipulation Effects as Influenced by Orthotics

Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques.

Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.

Eligibility Criteria:
Inclusion Criteria:

* Current low back pain episode present for one month or more
* No change in the past month in prescription medications affecting musculoskeletal pain
* Able to speak and understand English adequately to complete study forms
* Score on Roland-Morris questionnaire of 7.5 or higher or
* Average score on Chiropractic pain Index (Now, Average, and Worst scales from the Quadruple VAS pain scale) of 4 or higher.

Exclusion Criteria:

* Use of foot orthotics within the past 12 months
* Previous lumbar spine surgery
* Ongoing treatment for lower back pain by other health care providers other than stable prescription medications affecting musculoskeletal pain.
* Clinically significant chronic inflammatory spinal arthritis
* Severe osteoporosis for which spinal manipulation is contraindicated
* Spinal pathology or fracture
* Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
* History of bleeding disorder
* Known arterial aneurysm
* Pending/current litigation pertaining to back pain, including workers compensation claims
* Current pregnancy
* Lack of means of contacting which might preclude successful completion of study requirements
* Does not speak , read or understand English to an extent which would affect the subject's capacity to participate in informed consent