cyrilzakka/clinical-trials huggingface dataset:
SNV4818 in Participants With Advanced Solid Tumors

This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumor with an activating PIK3CA mutation.
* Refractory to or intolerant of available therapies
* Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Diagnosis of a primary CNS malignancy
* Active brain metastases or carcinomatous meningitis
* Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
* Inadequate organ function
* Clinically significant ECG abnormalities, including QTcF ≥ 470 ms
Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

The purpose of this study is to assess the extent of symptom remission in patients with trichotillomania following treatment with sertraline and/or behavior therapy.

The purpose of this study is to assess the extent of symptom remission in patients with trichotillomania following treatment with sertraline and/or behavior therapy.

Following entry into the study, subjects will undergo a washout period if they are currently taking a psychotropic medication (two weeks for psychotropic medications except for fluoxetine, which requires a four-week washout). Subjects will then be given a single-blind placebo for two weeks and assessed for symptom consistency.

Subjects will take sertraline or placebo in a double-blind design. Subjects will be assessed with the Hamilton Rating Scale for Depression (HAM-D-17), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health (NIMH) Scale, and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) at the start of the washout period and at the end of week two in order to be randomized into the study. Subject randomization to a treatment arm will be based on the random table and in equal proportions.

Subject change scores will be assessed for the above scales, and change scores for the four different treatment groups will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients will have a DSM-IV diagnosis of TTM.
* TTM symptoms for at least 4 months.
* Scalp as primary site of hair pulling.
* HPS score greater than or equal to 15 OR TTM Impact Scale score greater than 30.
* Written informed consent.
* Men or women aged 18-65 years old.
* Females of childbearing potential must have a negative serum beta-HCG pregnancy test.

Exclusion Criteria:

* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
* Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
* Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
* History of seizure disorder.
* Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder.
* If there is a history of substance abuse, patients must be in remission at least 6 months.
* Past trials of sertraline.
* Currently being treated with behavioral therapy, specifically habit reversal training, for TTM.
* Other medications for medical disorders that may interact with sertraline.
Plaque Stability and Metabolomics in Coronary Heart Disease

At present, the investigators don't know the relationship between plaque stability and the metabonomics changes. In the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. Statistic analysis were carried out to analyze the correlation between plaque stability and metabonomics changes among these study patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by IVUS will be recruited.

Exclusion Criteria:

* renal insufficiency with serum creatinine \> 20 mg/L;
* regnant/lactating women, or the women receive hormone replacement therapy in premenopausal or postmenopausal;
* patients have a history of abusing alcohol or other drugs in the past two years, active hepatitis, cirrhosis;
* endocrine abnormalities without therapy (diabetic ketoacidosis, thyroid disease, etc.);
* The body's inflammatory disease, rheumatoid arthritis, osteoarthritis, ulcerative bowel disease, systemic lupus erythematosus (sle), etc.), myositis/myopathy, cancer;
* Dilated cardiomyopathy, valvular heart disease, persistent atrial fibrillation;
* patients recently injured;（8）Other researchers don't agree to join this study.
Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair

Rehabilitation following rotator cuff surgery is characterized with high levels of pain, limited range of motion, and decreased quality of life. The purpose of this study is to evaluate the B-Cure laser photobiomodulation home-use device in addition to standard care, for the reduction of pain, increase in functionality, and improvement of life quality during rehabilitation following rotator cuff arthroscopic surgery.

Patients planned to undergo rotator cuff arthroscopy will be randomized to receive active or sham devices for self-application at home in addition to standard care. Patients will be invited to up to 5 visits at the clinic: baseline (before surgery), post-operative day 1, and 1, 3, and optionally 6 months after surgery. Evaluations will include physical examination, physical activity tests, range of motion measurements, Constant score, thermal imaging, and patient reported outcomes including subjective pain level by visual analogue scale, functional and quality of life questionnaires.

The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can reduce pain and accelerate healing over standard care thereby improving the rehabilitation process following rotator cuff arthroscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-65
* Men or women
* Full or partial rotator cuff tear
* Scheduled to undergo RCAS because of failure of conservative therapy (injections, medication, physiotherapy)
* Is willing to perform the full protocol
* Voluntarily sign and date an informed consent form
* Be able to understand and complete the various questionnaires

Exclusion Criteria:

* Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
* Participation in another clinical study within 30 days before screening
* Scheduled to undergo an elective medical procedure during the study timeframe that will interfere with the study as deemed by the PI
* Pregnant
* Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for shoulder pain
* Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light
* Has osteoarthritis
* Other chronic pain conditions: fibromyalgia, failed back surgery, back pain
* Avascular necrosis
* Rheumatoid arthritis
* Psychiatric disorders including major depression, schizophrenia, bipolar disease
Association Between Dermatoporosis and Fractural Risk

There is a need for new tools to identify patients who may have osteoporosis before a fracture occurs.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 40 and 90 years old who has to undergo a bone densitometry (BMD) examination by dual X-ray absorptiometry
* Affiliate or beneficiary of a Social Security scheme
* Express consent to participate in the study.

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or nursing woman.
Circular pOlyethylene Drape in preVention of Surgical Site infEction: A Randomized Controlled Trial

This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract.

Participants who are determined to undergo open abdomen surgery will be screening for the eligibility first. If eligible and agreed to participate, each participant will be assigned to either the experimental group or control group based on the electronic randomization. The experimental group will use the plastic ring wound retractor, while the control group will use a conventional surgical pad for wound protection method. Each participant will be blind to the randomization result because he/she will be under general anesthesia. Once the surgery is finished, the patient will be assessed on the surgical wound at postoperative day 1, 7, 14, 30. Two groups will be compared for the surgical wound infection rate.

Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years or less than 75 years
* either elective or emergent surgery for upper GI, small intestine, or colorectal disease
* open laparotomy
* the patient who agrees to participate in this trial

Exclusion Criteria:

* concurrent abdominal wall infection
* open conversion from laparoscopy
* poor nutritional status, NRS 2002 score 3
* combined hepatobiliary operation
* pregnant or breast-feeding state
* severe immunosuppression
Effects of Heme Arginate in Healthy Male Subjects

Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1 stimulation of heme arginate in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male aged between 18 and 45 years (inclusive) at screening.
* No clinically significant findings on the physical examination at screening.
* Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
* 12-lead ECG without clinically relevant abnormalities at screening.
* Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
* Negative results from urine drug screen at screening.
* Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to the study drug or any excipients of the drug formulation.
* Treatment with another investigational drug within 3 months prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
* Smoking within the last 3 months prior to screening.
* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
* Loss of 250 ml or more of blood within 3 months prior to screening.
* Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
* Positive results from the HIV serology at screening.
* Presumed non-compliance.
* Legal incapacity or limited legal capacity at screening.
Addition of Spironolactone in Patients With Resistant Arterial Hypertension

The purpose of this study is to evaluate the efficacy of spironolactone on lowering blood pressure when added to therapy in patients with resistant arterial hypertension.

Arterial hypertension resistant to therapy and requiring treatment with more then three antihypertensive drugs is common. At present there are is no standard therapy for resistant hypertension based on randomised clinical trials, neither data to guide addition of further drugs to therapy. Recently some observational and retrospective trials reported good effect of spironolactone in patients with resistant hypertension, but these data were not validated by prospective randomised clinical trials.

This is a multicentric, randomised, double blind clinical trial, which will evaluate the effect of addition of 25 mg spironolactone to current medication compared to placebo. The study will enroll patients with blood pressure over 140/90 mmHg during a clinical examination, which are using at least three antihypertensive drugs, one of them being a diuretic. Average daytime systolic and diastolic blodd pressure will be evaluated by ABPM (ambulatory blood pressure monitoring).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Resistant arterial hypertension: (blood pressure during clinical control exceeding 140/90 mmHg (or 130/80 mmHg in in diabetic patients or patients with renal disease with creatinine level of more than 133 μmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic

Exclusion Criteria:

* Pregnant or breastfeeding women, women in fertile age without ruled out pregnancy
* Severe hypertension over 180/110 mmHg
* Renal insufficiency with creatinine over 180 umol/l or GFR lower than 40 ml/min
* Hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l
* Porphyria
* Hypersensitivity to the compounds of Verospiron (Richter Gedeon, Hungary) drug
* Patients taking any aldosterone antagonist (spironolactone, eplerenone, kanreone)
The Inhibition of Platelet Antiaggregating Activity of Clopidogrel by Atorvastatin Detected by Erythromycin Breath Test: a Metabolic Inhibition of Hepatic Cytochrome P450-3A

The objective of this study is to determine if the action of the drug called clopidogrel, that you will start taking, will be decreased by another drug called atorvastatin, that you will also start taking. Clopidogrel is an oral antiplatelet agent that has been shown to prevent strokes and heart attacks. Atorvastatin is a cholesterol lowering agent.

Twenty adults 18-75 years of age requiring cholesterol-lowering agent and antiplatelet agent therapy will be recruited for this study during their cardiology clinic visitation. In one group, antiplatelet agent (clopidogrel) regimen will be administered first, then followed by cholesterol-lowering medication (atorvastatin). In the second group, atorvastatin will be administered first, followed by clopidogrel.

A new test called the erythromycin breath test will be administered to you three times during the study to measure how your liver will metabolize these drugs. Blood samples will also be obtained to assess platelet function. The criteria for exclusion are patient refusal or inability to give written consent, patients with allergic reaction to erythromycin, patients with known bleeding problems, liver disease, significant lung disease kidney disease and pregnancy. Patients with psychiatric impairment and documented history of substance abuse will also be excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-75 years of age without bias in racial and ethnic background, undergoing percutaneous coronary intervention requiring antiplatelet therapy: 1. Patients presented to cardiology clinic requiring cholesterol lowering agent 2. Patients presented to cardiology clinic requiring antiplatelet agent.

Exclusion Criteria:

* Refusal or inability to give written consent
* Allergic reaction to erythromycin
* Have known bleeding problems, liver disease, significant lung disease kidney disease
* Pregnancy
* Psychiatric impairment and documented history of substance abuse
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 75 years
* Symptomatic, single-level degenerative lumbar disc disease, spondylosis or spondylolisthesis
* Failed conservative treatments
* Low risk for non-union
* Must be candidates for single-level, posteriolateral lumbar spine fusion
* Must be able and willing to give Informed Consent
* English-speaking

Exclusion Criteria:

* Smoker (any smoking ≤3 months prior to consent); (Patel et al. 2013)
* Patients with poorly controlled diabetes mellitus (HgbA1c \> 7%)
* Documented osteoporosis
* Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine level, to the level being operated on
* Back pain due to infection, tumour, or metabolic bone disease
* Terminal disease, such as HIV infection, neoplasm
* Autoimmune disease, such as rheumatoid arthritis
* Morbid obesity (body mass index (BMI) of 35 kg/m2)
* Major psychiatric illness in the last year
* History of alcohol or drug abuse in the last year
* Pregnant women
Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)

To analyze the hypothetical improvement in anxiety degree, quality of life and fear of cancer in patients diagnosed with a small gastrointestinal subeptithelial tumor when opting for the removal of the lesion.

This "Quality of Life" study is directly related to the "BANDING-SET" study (NCT03247231), whose main aim is to analyze the effectiveness and safety of endoscopic band ligation without resection in the small gastrointestinal subepithelial tumours management.

Using three validated tests (Hospital Anxiety and Depression Scale \[HADS\], Cancer Worry Scale \[CWS\] and European Five-Dimension Quality of Live test \[EuroQol-5D\]) patients are evaluated before and after the endoscopic procedure.

Three main groups of patients are presented:

* GROUP A, in which the subephitelial tumour is successfully removed \[hypothesis: anxiety and fear of cancer should decrease\].
* GROUP B, in which the subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...) \[hypothesis: anxiety and fear of cancer shuold be similar before-after\].
* GROUP C, in which the subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients \[hypothesis: anxiety and fear of cancer should decrease\].

Eligibility Criteria:
INCLUSION CRITERIA:

* Age between 18 and 80 years.
* Patient able to sign and understand the Informed Consent.
* Patient with a previously corroborated diagnosis of a subepithelial tumor (SET) by previous endoscopic ultrasonography (EUS), or possible diagnosis of SET by finding a subepithelial lesion (SEL) in a conventional endoscopy performed that will require a EUS study.
* Acceptance by the patient as a candidate of the BANDING-SET study (NCT03247231) of assessment of the effectiveness and safety of band ligation without resection of subepithelial tumors of the digestive tract ≤15-mm, with the prior signing of the Informed Consent of this study.
* Patient that understand the concept of the study and will complete all the time frame until the study end

EXCLUSION CRITERIA:

* No Informed Consent.
* No BANDING-SET study (NCT03247231) Informed Consent.
* Patients with functional diversity, unable to understand the nature and possible consequences of the study.
* Patients unable to maintain subsequent follow-up (lack of adherence).
* Patients with a life expectancy of less than 12 months.
Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis

The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach.

While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).

In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.

Eligibility Criteria:
Inclusion Criteria:

* lumbar spondylolisthesis

Exclusion Criteria:

* infection of lumbar spine
The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients

The purpose of this study is to asses whether probiotics Lactobacillus rhamnosus (GR-1) and reuteri (RC-14) are able to prevent diarrhea, delay the decline of the immune system and prevent and/or cure bacterial vaginosis among HIV patients.

Background: Two third of all people infected with HIV live in Sub-Saharan Africa. A region also affected with a great burden of other infectious diseases. Relatively few patients have access to anti-retroviral treatment and many suffer from debilitating diarrhea that causes their immune system to deteriorate. Prevention of infectious diseases among HIV patients is of great importance and makes the immune system deteriorate less rapidly. The track record for probiotics to prevent and alleviate infectious diarrhea is impressive. So, the use of probiotics among HIV patients is a logical step and could be an adjunctive tool for physicians to halt the decline of the CD4 count.

Another important application for the use of probiotics is in the treatment of bacterial vaginosis (BV). BV is a vaginal infection, caused by a group of pathogens, which is extremely common, and estimated to occur in 50% of black African women. In the US, the prevalence is 29%, which again is extremely high. This infection makes a woman more vulnerable to contracting sexually transmitted infections, including HIV. Having BV is also a risk factor to transmit HIV to a partner or a newborn. Conventional antibiotic treatment of BV has a cure rate of 40% among black African women. A recent study shows that combining the probiotic strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 with an antibiotic has a cure rate of 88%.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV infection.
* Participant does not meet the criteria for ARV therapy, CD4 count \> 200, no clinical stage 3 or 4 \[National guidelines, 2005\].
* Having an intermediate Nugent score (4-6), or a positive Nugent score (7-10).

Exclusion Criteria:

* Pregnancy or lactating.
* Menstruation at time of diagnosis.
* Hypersensitive to metronidazole/warfarin/lithium/disulfiram.
* Not willing to avoid alcohol use during the metronidazole treatment of 10 days.