cyrilzakka/clinical-trials huggingface dataset:
GABA (Gamma Amino Butyric Acid) Medication for Tobacco

The goal of this study is to examine the effects of a GABA (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.

A total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300 mg/day pregabalin or placebo treatment. Each treatment condition will last 4 days, separated by 3 to 15 days of washout period. Smokers will have twice daily outpatient visits during the first 3 days and a test session on day 4. In each treatment period, smokers will abstain from smoking for 2.5 days, starting at 10 pm on Day 1 until the test session on Day 4. During the test sessions, measures of smoking behavior and tobacco withdrawal will be obtained.

Smoking is an important public health problem costing over 430,000 lives a year in this county alone. The first line-treatments, Nicotine Replacement Treatments (NRT) or bupropion, compared to placebo, approximately double the long-term success rate for smoking cessation. Given that there remains 46 million smokers in this country and over 70 percent of them interested in quitting smoking, development of new treatments for smoking cessation will have great public health implications.

Currently this protocol is complete with 24 completers. This study has been published. (April 2011)

Eligibility Criteria:
Inclusion Criteria:

* Female and male smokers, aged 18 to 55 years
* History of smoking daily for the past 12 months
* at least 15 cigarettes daily
* In good health as verified by medical history
* screening examination
* screening laboratory tests
* not pregnant as determined by pregnancy screening, nor breast feeding
* using acceptable birth control methods.

Exclusion Criteria:

* History of pregabalin allergy
* Use of psychotropic medication antidepressants, antipsychotics DSM-IV axis I diagnosis (schizophrenia, bipolar disorder, major depression
* Dependence or abuse of alcohol or any other illicit or prescription drugs
* current use of any other tobacco products, including smokeless tobacco
* history of seizures
* Inability to fulfill all scheduled visits and examination procedures
3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM

Statement of the problem: Soft tissue healing following immediate implant placement is one of the major factors that affect implant restoration, function \& success.

Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.

Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in molar sites region requiring implant placement. They will be randomly allocated to three equal groups. Group A (test group, n=12) will receive immediate implants (grafting with PRF), group B (test group, n=12) will receive immediate implants (grafting with HAM) and group c (test group, n=12) will receive immediate implants (no grafting). After implant placement, soft tissue healing (1ry outcome) and postoperative pain (2nd outcome) will be assessed. The parameters will be assessed at baseline, every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years old, with non-restorable first and second molars.
2. Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
3. Minimum alveolar Bucco-palatal dimension of 7 mm.

Exclusion Criteria:

1. Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
2. Patients who are smokers.
3. Presence of signs of active infection or pus formation.
4. Absence or loss of buccal wall prior to implant placement.
5. Bad oral hygiene
Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.

The objective of this study is to evaluate the efficacy and safety of masitinib in combination with docetaxel and prednisone with respect to placebo in combination with docetaxel and prednisone in the treatment of first line metastatic Castrate Resistant Prostate Cancer (mCRPC). Approximately 580 patients will be randomized in 2 groups with a ratio 1:1. The primary outcome measure is progression free survival. Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone \< 0.5ng/ml) with one of the following criteria:

   * Pre-treated with abiraterone with documented progressive disease, OR
   * Indicated for initiating docetaxel treatment (e.g., widespread visceral disease or rapidly progressive disease).
2. Patient with evidence of progressive metastatic disease as assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.
3. Patient with adequate organ function as per protocol

Exclusion Criteria:

1. Patient who has been previously treated with chemotherapy.
Milk Products in the Treatment of Hypophosphatemic Rickets

The aim of this study was to investigate the feasibility and efficacy of a high intake of milk and/or cheese products compared to phosphate tablets in patients with hypophosphatemic rickets when evaluating the S-phosphate levels as a main effect parameter. The study was designed as a randomized, multiple crossover study.

Objectives:

Standard treatment of hypophosphatemic rickets consists of oral phosphate tablets and vitamin D analogous. Due to their rapid absorption, serum-phosphate fluctuations can occur and secondary hyperparathyroidism may be a consequence. Our aim was to evaluate, if phosphate supplement administered as milk or cheese is superior or equal to phosphate tablets in patients with hypophosphatemic rickets

Study population:

Patients with genetic verified hypophosphatemic rickets were included in the period from August 2015 to June 2016. Patients were excluded from the study if they presented with tertiary hyperparathydoism, were treated with Cinacalcet or suffered from milk allergy.

Study design:

The study was designed as a randomized, multiple crossover study with three treatment periods consisting of the regular oral phosphate supplement, a high milk intake or a high cheese intake (randomization.com). Patients were instructed to discontinue their regular treatment, except for their usual doses of D vitamin analogs, three days prior to sample collection and instead engage in the study treatment. Furthermore, they should follow their normal eating habits while undergoing the study treatment, which was controlled by food and liquid registrations.

At the phosphate supplement session, the patients were treated with an 800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose. At the cheese session, the patients were treated with an estimated phosphate content of 800 mg distributed over 5 meals. At the milk session, the patients were treated with 800 ml of milk daily corresponding to approximately 800 mg phosphor per day.

Sampling:

After three days of treatment, the patients visited our clinic for anaerobically handled blood samples, which were collected 5 times through out one day for calcium, phosphate, parathyroid hormone, fibroblast growth factor 23 and basic phosphatase. Urine samples for calcium and phosphate was collected in containers from 0800 to 1200 and from 1200 to 1600. A 24-hour urine samples was obtained from the day before the sampling from 0800 to 0800 hours the following morning.

Eligibility Criteria:
Inclusion Criteria:

* Genetic verified hypophosphatemic rickets.
* In treated with oral phosphate tablets.

Exclusion Criteria:

* Tertiary hyperparathydoism.
* In treatment with Cinacalcet.
* Suffered from milk allergy.
Peroral Levosimendan in Chronic Heart Failure

The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.

The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed chronic heart failure
* Severe symptoms (NYHA IIIb-IV)
* Optimal on-going oral treatment for HF
* Left ventricular ejection fraction less than or equal to 30%

Exclusion Criteria:

* Severe obstruction of ventricular outflow tracts
* Acute myocardial infarction within 30 days before screening
* Cardiac surgery or coronary angioplasty within 30 days before screening
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects

This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.

Primary outcome measure is the safety and tolerability of study drug after a single dosing.

Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population.

Exploratory outcome measures include:

1. TOVA measures like response time , variability, omissions etc.
2. Subtests from Wechsler: digit memory, digit-number signs etc

Eligibility Criteria:
Inclusion Criteria:

* age 18-45
* diagnosed as ADHD

Exclusion Criteria:

* PDD patients
* head injured patients
* patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B
Consistency of PD-L1 Detecting Method Between E1L3N and 22C3 Monoclonal Antibodies in NSCLC Patients

Evaluated the correlation between the qualitative test results of Xiamen Aide PD-L1 antibody reagent (immunohistochemistry) and the efficacy of Keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent


Eligibility Criteria:
Inclusion Criteria:

1. ≥18，advanced non-small cell lung cancer confirmed by histopathology, and have received K-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged;
2. Able to provide FFPE samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5μm

Exclusion Criteria:

1. Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \<100);
2. K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy;
3. Other situations that the investigator thinks are not suitable for participating in this clinical study
Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. The aim of the study is to use a simplified magnetic resonance imaging (MRI) technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically.

Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content.

The aim of the study is to use a simplified magnetic resonance imaging technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically.

Patients who need a liver biopsy will be proposed to be enrolled in the study. A magnetic resonance (MR) study will be performed using breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence. Liver and muscle MR signal will be quantitatively determined and compared to biochemical assessment of liver iron concentration and steatosis quantification.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18,
* Planned liver biopsy (or liver biopsy within 2 months before inclusion) for one of these indications: suspicion of liver iron overload, metabolic syndrome, hepatitis B or C, alcohol abuse. No change in diet, transfusions or iron depletion must have occur between the liver biopsy and the MRI.
* Having given a written informed consent.

Exclusion Criteria:

* Non cooperating patient,
* Patient with dyspnea,
* Patient with contra-indication to MR imaging (pace-maker, heart valve,...).
B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)

To investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad libitum food intake after intake of the Metobes-compound (green tea extract, capsaicin, tyrosine, caffeine). Furthermore, to investigate if the effect of the Metobes-compound can be inhibited by blocking the β-adrenergic receptors.

The effect of the Metobes-compound will be investigated by:

1. 5-hour energy expenditure and respiratory quotient (ventilated hood).
2. 5-h change in blood pressure and heart rate
3. 5-h change in sympathetic/parasympathetic ratio.
4. Ad libitum energy intake.
5. Self-reported postprandiel appetite sensations (VAS).

Subjects 22 healthy Danish overweight to obese men (BMI between 25 and 35 kg/m2), 18 to 50 years of age. All subjects must be weight stable (within  3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication.

Method

The study is designed as a 4-way crossover, randomised, placebo controlled, double-blind study. Each treatment will be separated by \>1-week washout period. The treatments will consist of:

1. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 5 mg propranolol.
2. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 10 mg propranolol.
3. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with a placebo tablet for propranolol (microcrystalline cellulose).
4. Placebo for the Metobes compound (microcrystalline cellulose) together with a placebo tablet for propranolol (microcrystalline cellulose).

On each test day body weight and composition will be assessed. All subjects will undergo a 5-h post dose assessment of energy expenditure by indirect calorimetry in a ventilated hood. Subjective appetite sensations, ECG and dual measures of blood pressure/heart rate will be assessed every 30 minutes. After completed respiratory measurements the subjects will be served an ad libitum lunch meal (pasta salad).

All subjects shall collect all urine excreted during the respiratory measurements. Urine samples will be analyzed for nitrogen content and content of catecholamines.

Eligibility Criteria:
Inclusion Criteria:

* 21 healthy Danish normal-weight to obese men (BMI between 20 and 35 kg/m2), 18 to 50 years of age. All subjects must be weight stable (within  3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication.

Exclusion Criteria:

* They will be excluded if they do not meet the inclusion criteria and/or the blood pressure is above 165/95 mmHg and/or the ECG is abnormal.
Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients

Is a randomized, double-blind, placebo-controlled trial to determine the behavior of hyperglycemia and postprandial lipemia after a standard mixed meal load in patients with carbohydrate intolerance treated with acarbose.

To gather our patients, we invite the relatives of diabetic patients seen at the endocrinology consultation to participate in the study.

* Patients are placed into an isocaloric diet for 4 weeks before the study and are advised not to change their baseline physical activity.
* Patients are randomized to receive acarbose or placebo for 3 months blinded to investigators and patients.
* Acarbose dose is progressively titrated (50 mg/day per week up to 150 mg/day) to reduce the known adverse effects of acarbose such as flatulence, bloating, diarrhea, abdominal pain.
* In each subject, a 5-hr-postprandial mixed meal test is performed at baseline and after assigned treatment was completed. Glucose, insulin, triglycerides and total cholesterol were measured at 0, 5, 10, 20, 30, 60, 120, 180, 240 and 300 minutes after the mixed meal load. Apo B was measured by nephelometry and oxLDL using a monoclonal antibody 4E6 based competition (ELISA assay, Mercodia) at 0 and 300 minutes.
* The standard mixed meal load, a 470 kcal breakfast, (47.76% carbohydrate, 22.66% proteins, 29.58% fat), consisted of: 1 sandwich (prepared with 50 g of Savory´s™ turkey breast ham, 30 g of Savory´s™ panela cheese, 2 tablespoons of Hellmann's™ mayonnaise and 2 slices of Bimbo´s™ white bread), 100 g of Red DeliciousTM apple and 250 mL of Alpura´s™ lactose-free, light milk.
* During the 3-month treatment, patients have 3 follow-up monthly consultations to evaluate weight gain and treatment compliance.

Eligibility Criteria:
Inclusion Criteria:

* Recent diagnosis of carbohydrate intolerance according to the WHO criteria, without any treatment.

Exclusion Criteria:

* patients with BMI \>32 kg/m2, triglycerides and/or total cholesterol \> 300 mg/dl, known renal, liver or gastrointestinal disease and positive smoking.
Role of Clinical Pulmonary Infection Score and Sonopulmonary Infection Score in Diagnosis and Predicting Outcome of VAP in RUCU

-Pneumonia is a bacterial, viral or fungal infection of the lungs, which causes the alveoli of the lungs to fill up with microorganisms, fluid and inflammatory cells, preventing the lungs from functioning effectively

The classification scheme for pneumonia in UK NHS hospitals is based on the setting in which the infection was mostly likely acquired:

community-acquired pneumonia (CAP), when a patient is in the hospital \<48h before the pneumonia is suspected; hospital-acquired pneumonia (HAP), when a patient is in the hospital \>48h before the pneumonia develops, but is not associated with mechanical ventilation; and ventilator-associated pneumonia (VAP), when a patient is mechanically ventilated and intubated for \>48h before the pneumonia develops The causative pathogens in each scenario are different, and treatment strategies vary as a consequence.

-Pneumonia is a bacterial, viral or fungal infection of the lungs, which causes the alveoli of the lungs to fill up with microorganisms, fluid and inflammatory cells, preventing the lungs from functioning effectively

The classification scheme for pneumonia in UK NHS hospitals is based on the setting in which the infection was mostly likely acquired:

community-acquired pneumonia (CAP), when a patient is in the hospital \<48h before the pneumonia is suspected; hospital-acquired pneumonia (HAP), when a patient is in the hospital \>48h before the pneumonia develops, but is not associated with mechanical ventilation; and ventilator-associated pneumonia (VAP), when a patient is mechanically ventilated and intubated for \>48h before the pneumonia develops The causative pathogens in each scenario are different, and treatment strategies vary as a consequence.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 yrs or more Mechanically ventilated patients after 48 hrs after admission of ICU

Exclusion Criteria:

* Patient less than 18 yrs Patients diagnosed as pneumonia
Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19

This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
* Has had symptoms consistent with COVID-19 with onset 5 days before randomization
* Has one or more COVID-19-related signs or symptoms on the day of randomization
* Phase 2: Is an adult aged 18 years and above
* Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening

Exclusion Criteria:

* Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.
* Has severe COVID-19 or is on supplemental oxygen
* Has a history of a positive SARS-CoV-2 antibody serology test
* Has participated, within the last 30 days, in a clinical study involving an investigational intervention
* Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study

NOTE: Other protocol defined inclusion/exclusion criteria apply