cyrilzakka/clinical-trials huggingface dataset:
Transcranial Magnetic Stimulation in the Treatment of Addiction

The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on the right side of the head will make craving towards alcohol less severe in recently detoxified alcohol addicted patients.

Although there are successful treatment option to detoxify patients form their alcohol use, many patients tend to relapse. This relapse is mainly caused by a high level of (uncontrollable) craving towards alcohol. This aspect of addiction is with the existing options hard to treat, there is a great need of new successful treatment modalities. rTMS is a FDA approved treatment method for depression. Recently some small scale studies have shown promising results on rTMS in the treatment of addiction. In this study the investigators focus on alcohol addiction since it is the addiction with the highest morbidity and mortality in the Netherlands.

In this study the investigators focus on three levels of interest: the biological level, the functional level and the clinical level. The investigators will measure the effect of rTMS directly on brain activity through EEG recording. The investigators investigate its effects on cognitive performance through the use of neuropsychological computer tasks. The investigators will address clinical behavior (craving and alcohol use) with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed males between 23-65 years of age
* A primary diagnose of alcohol dependence (meeting the DSM-IV-TR criteria 303.90/ICD-10 F10.2)
* Written consent for participation of the study.

Exclusion Criteria:

* MATE outcome \<4 (as extracted from part 4 MATE at enrollment phase)MATE= Dutch screening instrument on (among others) addiction severity
* Presence of a current or past relevant somatic or neurological disorder
* Meeting the DSM-IV-TR criteria for a current bipolar disorder, schizophrenia, anxiety disorder or moderate to severe depressive disorder. These disorders would be a possible great confounder. Measured with the MINI-plus.
* Meeting the DSM-IV-TR criteria for current (in the past 2 weeks) dependence of substances other than alcohol, nicotine or caffeine. Information present in MATE.
* Participant-bound factors that may endanger participants or may jeopardize study adherence, because of failure to understand and/or comply with instructions (e.g. current, disruptive symptoms such as psychotic symptoms or severe cognitive impairment)
* Contra-indications resulting from the use of rTMS:

  * Epilepsy, convulsion or seizure
  * Serious head trauma or brain surgery
  * Large or ferromagnetic metal parts in the head (except for a dental wire)
  * Implanted cardiac pacemaker or neurostimulator
Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy

Eligible patients undergoing hysteroscopy were randomly assigned in a 1:1 ratio to receive intravenous anesthesia with either propofol (2 mg/kg) or remifentanil (0.4 mg/kg).Continuous monitoring of pulse oximetry (SpO2), blood pressure (BP), heart rate (HR), expired gas partial pressure of carbon dioxide, integrated respiratory index (IPI), tidal volume (TV), respiratory rate (RR), and minute ventilation (MV) was performed.During induction, the MOAA/S score was assessed every 30 seconds. If the MOAA/S score remained \>1, a supplementary dose of 1/2 of the initial dose was injected within 10 seconds.If more than 5 supplementary doses were required within 15 minutes, it was considered that the painless hysteroscopy failed and propofol was used to enhance sedation.Continuous oxygen administration at a flow rate of 5 liters per minute was provided through nasal catheters until the patient was fully alert with a MOAA/S score of 5 and vital signs were stable.Observation indicators included: (1) the success rate of hysteroscopy;(2) induction time (MOAA/S ≤ 1 after the first dose);(3) full recovery time of consciousness;(4) operation duration;(5) number of additional anesthetics;(6) incidence of hypotension, hypoxemia, sinus bradycardia, delayed recovery, and injection pain;(7) respiratory parameters and minimum SpO2, IPI values before anesthesia, after induction, and after awakening.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary signing of informed consent form
* Stable vital signs and qualified anesthesia outpatient evaluation
* No contraindications to anesthesia

Exclusion Criteria:

* Not willing to sign informed consent form
* Anaesthesia drug allergy
* Severe central nervous system diseases
* Severe hypertension and diabetes
* Mental disorders
* History of using psychotropic drugs in the past 3 months
Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.

The ATLANT study is prospective, multicentre, non-interventional, observational study. Patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy.

The ATLANT study is prospective, multicentre, non-interventional, observational study.

136 patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy in different line therapy.

The purpose of this study is to better understand how abemciclib combinations are used in real-life conditions and their clinical impact for the treatment of Russian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor \[PgR\]) as defined in the relevant American Society of Clinical Oncology/College of American Pathologists Guidelines: For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC)
3. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
4. Patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not amenable to curative therapy.
5. WHO performance status of 0-2
6. The patient has adequate organ function
7. Any number of prior therapies (including none) is permitted
8. Рatients who will start Abemaciclib as a Single Agent or in combination with endocrine therapy

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.
2. Participants must not be pregnant or breastfeeding
New Treatment for Donor Sites

Primary research questions/Purpose of the Research.

1. Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and thrombin (HT).
2. Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.

   b. Describe the importance of the knowledge that you expect to gain from the research.

   To find a donor site dressing that has outcomes equal or better than that of scarlet red.


Eligibility Criteria:
Inclusion Criteria:

* Ages 0-90 years.
* Any patient admitted to the hospital with burn injury requiring grafting and a donor site.

Exclusion Criteria:

* Patient with severe burn injuries expected to die.
Intense Pulsed Light in Meibomian Gland Dysfunctions

Dry eye disease (DED) is an extremely common disease whose meibomian gland dysfunction is the main etiology.

Polychromatic intense pulsed light (IPL) is a promising new therapeutic alternative but few clinical data have been published.

A new IPL device has recently been marketed: LACRYSTIM (QUANTEL, France). The investigators have been using it in our clinical practice since June 2019.

The investigators present a retrospective study on our first clinical results.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Dry eye disease with meibomian gland dysfunction, preferentially mild to moderate, and having benefited from intense pulsed light treatment.
* patient affiliated with a social security organization

Exclusion Criteria:

* patient with incomplete follow-up
Vitamin D, Glucose Control and Insulin Sensitivity in African-Americans

North American blacks tend to have low blood levels of vitamin D because pigmentation blocks vitamin D production in the skin. They also have higher rates of developing type 2 diabetes and higher rates of complications from the disease compared with whites. Although there is compelling evidence that adequate vitamin D may reduce the risk for type 2 diabetes in whites, recent evidence from a national survey demonstrated an association of vitamin D with diabetes in whites but not in blacks. However, the central hypothesis of this study is that providing enough supplemental vitamin D to blacks (raising their blood levels higher than that of most participants in the survey) will improve blood measures related to diabetes risk. The proposed study is a 12-week randomized, double-blind, placebo-controlled experiment designed to examine the effect of vitamin D supplementation (100 μg/d ) on insulin secretion, insulin sensitivity and glucose control in pre-diabetic black men and women aged 40 and older.


Eligibility Criteria:
Inclusion Criteria:

* African-American by self designation
* Glucose intolerance defined as FPG ≥ 100 mg/dl or A1c ≥ 5.8%
* BMI 25.0-39.9
* Age 40 or older

Exclusion Criteria:

Medical Conditions

* Diabetes potentially requiring pharmacotherapy, defined as A1c \> 7%
* Uncontrolled thyroid disease
* Current parathyroid, liver or kidney disease
* Renal stone within 5 years
* Sarcoidosis, current pancreatitis, active tuberculosis, hemiplegia, gout
* Inflammatory bowel disease, colostomy, malabsorption
* Cancer other than basal cell skin cancer within 5 years
* Uncontrolled arrhythmia in past year
* Albinism or other condition associated with reduced skin pigmentation
* Pregnancy over the last 1 year
* Intent to become pregnant
* Menopause onset within 1 year
* Any other unstable medical condition Laboratory Tests
* Fasting plasma glucose \< 100
* Hemoglobin A1c \> 7%
* Laboratory evidence of liver disease (e.g. AST \> 70 U/L or ALT \> 72 IU/L)
* Laboratory evidence of kidney disease (e.g. estimated glomerular filtration rate \< 60 ml/min/1.73 m2).
* Elevated spot urine calcium to creatinine ratio \> 0.38 mg/dl\*
* Abnormal serum calcium (serum calcium \> 10.5 mg/dl)
* Anemia (Hematocrit \< 36% in men, \<33% in women) Medications (use in past three months)
* Estrogen or testosterone
* Prescription vitamin D
* Lithium
* Oral corticosteroids
* Anti-seizure medications
* Unstable doses of psychotropics or phenothiazines
* Cholestyramine Supplements (current use - may discontinue after screening)
* Vitamin D supplements, cod liver oil, calcium supplements Other
* Body mass index less \<25 or \> 39.9
* Consumption of more than 14 alcoholic drinks per week
* Inability to attend all three study visits as scheduled
* Inability to provide written informed consent
* age \< 40 years
* not African-American (by self-designation)
* Participation in another research intervention study

  * corresponds to a 24-hour urinary calcium excretion \> 400 mg
Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study

The purpose of this study is to examine the effects of modifiable lifestyle factors including exercise and healthy living on brain health. The investigators will compare 2 types of interventions, moderate aerobic walking vs. healthy living education, over 6 months to evaluate changes in brain health, cognition, and physical function in older adults with cognitive concerns.

Cognitive decline in older adults is a major public health issue. The cost of caring for older adults with substantial cognitive impairment, like those with Alzheimer's Disease in the US is approximately $200 billion a year, causing major societal, economic, and caregiving burden. Despite great advances towards diagnosing these problems, the discovery of effective treatments has been minimal. Exploring non-pharmacological interventions, such as exercise and healthy living, have gained momentum. These promising, modifiable lifestyle interventions have the potential for delaying disease onset and slowing decline in cognition. However, the therapeutic effect of lifestyle interventions in patients with mild cognitive impairment, a prime intervention period for treatment, is not well understood. Therefore, in this study, the investigators will examine brain, body, and cognitive changes in older adults who engage in moderate-aerobic walking or healthy living education.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. English-speaking
3. 55-80 years old
4. Exhibits sedentary behavior
5. Objective cognitive impairment
6. Mini-Mental State Exam score \> 26
7. Perform at least 1 standard deviations below normative values on cognitive tests
8. Absence of dementia
9. Ability to complete both MRI and PET scans
10. Physically capable of completing health programs

Exclusion Criteria:

1. Baseline dementia
2. History of a neurological disorder
3. Current psychiatric illness
4. Head trauma with a loss of consciousness \> 10 minutes
5. Severe sensory deficits
6. Substance abuse
7. Depression (GDS \< 8 of 15)
8. Inability to perform intervention (e.g., inability to walk without assistance)
9. Contraindications to MRI scan (e.g., pacemaker)
Does Timing of Completion Radical Cholecystectomy Determine the Survival in Incidental Carcinoma Gallbladder

Various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. Timing of re-intervention is suggested to play an important role in the outcome. Few centers are proponents of early surgery in order to prevent dissemination, while others have suggested an intentional delay of 3 months to filter out cases with aggressive pathology. In the present study, investigators intend to evaluate the factors affecting survival in incidental Gallbladder Cancer (IGBC) with special reference to timing of re-intervention.

Surgical Gastroenterology department at our institute is a tertiary referral center for hepatobiliary malignancies; covering a large part of North and North-east India. The details and progress reports of patients of Gallbladder Cancer (GBC) being referred to and treated at the institute is maintained in a prospective manner on hospital data base. This includes demographic data, presenting complains, details of relevant investigations done outside and in the hospital, previous surgery, pre-hospital course, operative findings, post operative course and final histopathology. Being a retrospective analysis of data not affecting clinical outcomes, ethical approval was not taken. During the study period (Jan 2009 to Dec 2018), 1049 participants with diagnosis of GBC (including 91 IGBC participants) were admitted; 239/958 participants with diagnosis of GBC and 48/91 with diagnosis of GBC could undergo resection with curative intent. Information regarding adjuvant therapy, recurrence, and survival were retrieved through data maintained on follow up out-patient cards till December 2019. Few participants who stopped visiting the hospital were contacted telephonically or through letters. All available histopathology blocks and slides following the index cholecystectomy were re-reviewed by the pathologists in the institute. Tumor type, differentiation and primary T stage were documented for majority of cases. Interval between index cholecystectomy and date of re-operation was calculated for all the participants and divided into 3 groups: Early (\<4weeks), Intermediate (4-12 weeks) and Late (\>12 weeks). Primary objective was to assess the effect of tumor characteristics and the time gap (between index surgery and re-resection) on overall survival following curative (R0/R1) resection.

Eligibility Criteria:
Inclusion Criteria:

All incidental carcinoma gallbladder patients who could undergo curative resection during the study period (Jan 2009 to Dec 2018)

Exclusion Criteria:

Metastasis on preoperative investigation or on staging laparoscopy
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female between 21 and 75 years old
* Body Mass Index (BMI) of 25 or more

Exclusion Criteria:

* Chronic Liver disease other than NASH
* Uncontrolled diabetes
* Any major surgery within 6 weeks of screening
* Unable to self-administer under the skin injections
* Any bone trauma, fracture or bone surgery within 8 weeks of screening
CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of interventional radiology under scan in the thoraco-abdominal level.


Eligibility Criteria:
Inclusion Criteria:

* More or equal the 18 years old
* Patient for whom an indication of diagnostic or therapeutic percutaneous interventional gesture in the thoraco-abdominal level under CT guidance is prescribed
* Patient affiliated to social security or similarly regime
* Patient signed consent for participation in the study.

Exclusion Criteria:

* Patient with a medical device using a magnetic field (eg, patient with a pacemaker)
* Patient who presents ferromagnetic foreign bodies intracorporeal close to the working zone of Radiologist, and that can interact with the medical device
* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Person deprived of freedom by judicial or administrative decision
* Person under legal protection
Transverse Supraumbilical Versus Pfannenstiel Incision for Cesarean Section in Morbidly Obese Women

This study aims to evaluate the efficacy and safety of transverse supraumbilical incision over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.

Research Question In Morbidly obese women undergoing cesarean section, is transverse supraumbilical incision superior to Pfannenstiel incision? Research Hypothesis Transverse supraumbilical incision is superior to Pfannenstiel incision in morbidly obese women undergoing cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* BMI more than 40 kg/m2
* women scheduled for CS

Exclusion Criteria:

* patients receiving steroids or anticoagulation
A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving an initial antiretroviral therapy (ART) regimen composed of the drug abacavir (ABC) 300mg twice a day, plus the drug 3TC (lamivudine) 150mg twice a day in combination with either a protease inhibitor or non-nucleoside reductase inhibitor (NNRTI) for at least 24 weeks.
* NOTE: Subjects who have required a change in initial protease inhibitor (PI) or NNRTI therapy due to intolerance (not treatment failure) are eligible. Subject must be on a stable regimen of the second PI or NNRTI therapy for at least 6 months before enrollment in this study.
* Plasma HIV-1 RNA less than 400 copies/mL for at least 3 months immediately preceding the screening visit, and at screening.
* CD4+ cell count of at least 50 cells/mm3 at screening.
* Written informed consent to participate in the study before participation.
* Male or female (Females of child-bearing potential must have a negative serum pregnancy test at screening and agree to an acceptable method of contraception.)

Exclusion Criteria:

* History of a CDC Clinical Category C event requiring treatment (not including cutaneous Kaposi's sarcoma) within 45 days of the screening visit. Treatment for the acute event must have been completed at least 30 days before screening.
* Subject is enrolled in one or more investigational drug studies which may impact HIV RNA suppression.
* Subject is unable to complete the 48-week dosing period, evaluations and assessments.
* Subject is pregnant or breastfeeding.
* History of clinically relevant inflammation of the pancreas or hepatitis within 6 months prior to screening.
* Subject suffers from a serious medical condition, such as diabetes or heart problem.
* Pre-existing mental, physical, or substance abuse disorder.
* History of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction.
* Abnormal laboratory results within 28 days before the first dose of study medication.
* Required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days before screening, or will need these during the study.
* Subject requires treatment with immunomodulating drugs such as systemic corticosteroids, interleukins, vaccines, or interferons within 28 days prior to screening, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
* Asthmatic subjects using inhaled corticosteroids are eligible for enrollment.
* Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of screening.
* Subject has a history of allergy to any of the study drugs.
An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.


Eligibility Criteria:
Inclusion Criteria:

* Male or non pregnant female
* Good general health
* Sufficient abdominal fat for injections
* Signed informed consent
* BMI greater than or equal to 18 and less than 28 kg/m2
* History of stable weight in past 3 months

Exclusion Criteria:

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days of first dose
The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)

The goal of this registry is to collect data on patients referred for clinically indicated coronary vasomotor function test (CFT) and answer different questions on prevalence, safety and outcomes. The registry is observational. Patients receive yearly online questionnaires on their anginal complaints for 5 years after their CFT.


Eligibility Criteria:
Inclusion Criteria:

* Referred for clinically indicated CFT

Exclusion Criteria:

* Not willing to provide informed consent