cyrilzakka/clinical-trials huggingface dataset:
N-Acetylcysteine and Smoking Reduction

N-acetylcysteine is an inexpensive agent with a benign side effect profile with preliminary studies in humans suggesting efficacy for the treatment of cocaine dependence. N-acetylcysteine has been used in clinical medicine for nearly three decades to treat chronic lung conditions, acetaminophen overdose, and experimentally to treat cocaine dependence. It is generally safe and well tolerated. The present pilot study seeks to explore safety and tolerability, ad lib smoking, visual cue reactivity, and smoking reduction rates in a group of nontreatment seeking, nicotine dependence smokers who are willing to undergo a brief trial with oral N-acetylcysteine 1200 mg twice daily.


Eligibility Criteria:
Inclusion Criteria:

1. Be smokers motivated to reduce their cigarette usage but not seeking treatment to quit smoking at the time of screening.
2. Be Able to give written informed consent after being presented with an IRB-approved informed consent document
3. Be male or female of any race, between eighteen and sixty five years of age.
4. Be in stable physical and mental health as judged by interview
5. Be smoking 10 or more cigarettes per day for one or more years
6. Have an expired CO reading of ≥10 parts/million prior to beginning study
7. Test non-pregnant and use adequate birth control (female only). All female subjects will have a urine pregnancy test performed prior to the first dose of study medication.
8. Be able to comply with protocol requirements and be likely to complete all study treatments.
9. Live within 50 miles of the study site

Exclusion Criteria:

1. Have current dependence, defined by DSM IV criteria, on any psychoactive substance other than nicotine, alcohol, or marijuana or physiological dependence on alcohol requiring medical detoxification.
2. Have a history of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorders.
3. Have a history of adverse reaction/hypersensitivity to N-acetylcysteine.
4. Have any significant active medical or psychiatric illness (e.g. schizophrenia, suicidal/homicidal ideation within the past 30 days) which might inhibit their ability to complete the study or might be complicated by administration of NAC.
5. Used carbamazepine or Nitroglycerin within the last 14 days or any other medication felt to be hazardous if taken with NAC
6. Have a current or past history of asthma and/or the occasional or daily use of Albuterol or other beta-agonist inhalers.
7. Females pregnant or breast-feeding
8. Have any medical history or condition considered by the investigator(s) to place the subjects at increased risk.
9. Not fail to actively meet the inclusion criteria at the time of screening.
10. Have a history of childhood or adult seizures of any cause.
11. Be currently taking any medications (i.e., beta-blockers, stimulant medications) that might affect heart rate or skin conductance
Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

This study is a series of descriptive-analytic studies on genomic variants in the facial skin of patients with AV at the Dermatology and Venereology Polyclinic by determining the genetic profile by GWAS examination in AVB and analysing the genetic profile in AVB against differences in geographical location. The research design used was a cross-sectional design.

Research subjects were obtained from the affordable population who met the research criteria and expressed their willingness to participate in the study.

Subject selection was carried out by purposive sampling method that met the inclusion criteria. The study will be conducted in one visit where the patient and his/her parents come to be given an explanation about the study with a request for informed consent, screening for inclusion and exclusion criteria, anamnesis of facial complaints, taking data on demographics, patient's medical history, patient's medical history, physical examination, taking clinical photos in 5 positions and ending with taking blood samples of the patient and blood samples from both parents of the patient as much as 10 mL.

The study will be conducted in three places, namely in Jakarta, Padang, and Manado. In sampling in Padang and Manado, to prevent damage to the samples that have been taken, the samples will be stored at a temperature of -20C, then when brought to Jakarta will use a cooler box along with an ice pack at a temperature of 2-3C, before being processed in the Bioinformatics Core Facilities IMERI laboratory, Jakarta. When the samples are collected in Jakarta, the blood samples will be immediately stored in the laboratory at -20C.

Eligibility Criteria:
Inclusion Criteria:

* Males or females with AVB aged 17-21 years
* Both parents of complete subjects with or without a history of acne vulgaris aged up to 60 years
* Patients and parents are willing to participate in the study and sign informed consent.

Exclusion Criteria:

* Patients who have other inflammatory or infectious diseases especially on the face
* Have genetic diseases or disorders
* Diagnosed with primary or secondary immunodeficiency diseases
* Using oral or systemic antibiotic, anti-inflammatory, retinoid or hormone therapy in the past month.
Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy

Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively.

A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug.

Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs.

Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed.

Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is \> 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted.

Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting

Eligibility Criteria:
Inclusion Criteria:

* adult (40-65 years)
* ASA I-II women
* scheduled to undergo open elective abdominal hysterectomy with or without salpingo-oophorectomy

Exclusion Criteria:

* renal impairment,
* allergy to any of study's drugs,
* history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease,
* severe cardiac comorbidity (impaired contractility with ejection fraction \< 50%, heart block, significant arrhythmias, tight valvular lesions),
* patients undergoing surgery for suspected gynaecological cancer,
* patients on chronic analgesic medication,
* inability to comprehend the Visual Analogue Pain Scoring Scale
Effect of Time Shift of Transcranial Direct Current Stimulation (tDCS) for Treatment of Acute Tinnitus

The treatment for patients with acute tinnitus consists of Methylprednisolone and hyperbaric oxygen therapy. For this study transcranial direct current stimulation (tDCS) was added to the protocol. The purpose is to determine the effect of the time shift of tDCS. Two conditions will be compared: tDCS simultaneously with the hyperbaric oxygen therapy or tDCS 3 weeks after the start of the tinnitus.

An audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks and 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50 years
* presence of acute tinnitus or worsening of tinnitus caused by otogenic disease
* registration in UZA within 48 hours after start tinnitus
* VAS-score ≥ 4
* ability to understand and sign informed consent

Exclusion Criteria:

* history of epileptic seizures
* severe organic comorbidity
* psychiatric disorders or a history of psychiatric disorders with psychotic symptoms
* Pace maker
* pregnancy
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment
* Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months

Exclusion Criteria:

* Current or anticipated enrollment in another investigational drug or device study
* Females who are pregnant, nursing, or planning a pregnancy during the study
The Effect of Reiki on Breastfeeding Self-efficacy, Pregnancy Complaints and Quality of Life

Despite the benefits of reiki application, no study has been found that examined the effects of reiki on breastfeeding self-efficacy, complaints during pregnancy and quality of life in pregnant women.

Reiki, one of the complementary and alternative therapy (CAM) methods; It means "universal life energy" and is natural healing energy (Müller \& Günther, 2006). This healing method is a way of treating others physically and spiritually (Vitale\&O'Connor, 2006; Yücel, 2007). Reiki focuses on energy chakras and bio-psycho-spiritual healing. Reiki enables vital signs (blood pressure, pulse rate, respiratory rate) to reach normal levels, reduces acute and chronic pain, facilitates sleep, reduces anxiety and fear, relieves depression, reduces stress, provides relaxation, reduces the use of painkillers and increases coping skills. (Anderson \& Ameling, 2001; Kelley \& William, 2009; Lee et al., 2003; Pocotte \& Salvador, 2008; Vitale, 2006).

Nurses are responsible for increasing the general health level of the mother by detecting and treating the existing diseases in the pregnant, providing timely diagnosis and treatment of potential problems that may arise, monitoring and evaluating the development of the mother and the fetus during pregnancy, giving care to the mother during pregnancy, general body care, nutrition, activity, family planning, It is responsible for providing information on signs of danger, care of the newborn and other issues that the mother may need, preparing the mother for birth physiologically and psychologically, thus increasing the quality of life of the mother (Taşkın, 2016).

Eligibility Criteria:
Inclusion Criteria:

First pregnancy In 28th and above gestational week Able to read and write Open to communication

Exclusion Criteria:

Having psychiatric history Diagnosed with risky pregnancy Having congenital anomaly in the baby in the postpartum period Having the childbirth preparation classes Receiving energy therapies before and having reiki training certificate
HOP-2A - Intratesticular Hormone Levels

The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

We will collect a very small amount of fluid from each testicle. Participation will last up to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day, fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).

Eligibility Criteria:
Inclusion Criteria:

* males between 18 and 50 years of age
* sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology
* in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels)
* body mass index ≥18 and ≤32 kg/m2
* must agree not to participate in another research study involving drug exposure for the duration of the study

Exclusion Criteria:

* men in poor general health, with abnormal blood results
* sperm counts \<20 million/ml on two tests
* chronic, ongoing alcohol or drug abuse
* participation in a long-term male contraceptive study within the past three months
* history of testicular or scrotal surgery
* history of infertility
* abnormal testicular exam
* abnormal DRE
* chronic pain syndrome
* use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids
* known bleeding disorder
* use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)
Forward and Backward Walking Exercise on Physical and Cognitive Functions

To investigate the acute effects of forward and backward walking exercise on physical functions such as static and dynamic balance and cognitive functions such as attention, concentration, memory, processing speed, visual structuring skills, calculation and orientation.

This study is planned to investigate the acute effects of forward and backward walking on physical functions such as static and dynamic balance and cognitive functions such as attention, concentration, memory, processing speed, visual structuring skills, calculation and orientation. 50 healthy individuals were randomly divided into three groups for the study. The groups were divided into Backward Walking Exercise Group (GYE) (n=17), Forward Walking Exercise Group (FWE) (n=16) and Control Group (CG)(n=17). Before treatment for all three groups; sociodemographic and clinical data with the sociodemographic information form, physical activity levels with the International Physical Activity Survey Short Form, pain severity with the Visual Analog Scale (VAS), fatigue levels with the Borg Scale, the person's selective attention capacity and skills, processing speed and general executive processing abilities. Stroop Test with TBAG Form to evaluate executive functions such as working memory, complex attention, planning and set shifting, with Trail Making Test, evaluation of dynamic balance, neuromuscular control and movement asymmetries with Y-Balance Test, static balance, postural stability evaluation on One Leg It was evaluated with the Standing Test. The GYE group completed a 25-minute backward walking exercise session, the FWE group completed a 25-minute forward walking exercise session, and the control group completed a 30-minute sitting rest between evaluation tests. After the exercises, there were significant differences in parameters such as attention, processing speed, concentration and maintenance of attention, working memory, planning, static and dynamic balance, and in the comparison between groups, significant differences were found in static balance and postural control (p\<0.05). It was observed that individuals in the backward walking group showed better improvements in some parameters after walking. However, these results need to be supported by future studies.

Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-25,
* To be able to communicate verbally and in written Turkish,
* Not complaining of pain in any part of the body during physical activity,
* Performing a normal walking pattern without compensatory movements.

Exclusion Criteria:

* Participants participating in a routine exercise program
* History of upper or lower extremity pathology or injury in the last 6 months
* Diagnosed neurological disease
* Diagnosed cognitive impairment
* Having a diagnosed orthopedic disease
* Using a walking aid
* Inadequate cardiovascular fitness
* Dyspnea on exertion
* Contraindication to walking
* Receiving medical treatment that causes imbalance.
Cortisol Levels as a Measure of Accumulated Physiological Stress in ICU Patients Undergoing Mechanical Ventilation

Critical illness is a situation of severe and prolonged stress for patients with mechanical ventilation (MV). Between 40-80% of these patients present the Post-ICU syndrome, a set of physical, cognitive, psychological alterations at hospital discharge. In more than a third of the ICU survivors, these sequelae become chronic being observed months and even years after ICU stay.

The characteristics of the Post-ICU syndrome have been related to different risk factors associated with the critical illness and its management. However, the impact of accumulated physiological stress is still unknown. The physiological response to prolonged stress generates high levels of cortisol that have been related to the loss of muscle tissue, cognitive and psychological alterations in both clinical populations and healthy subjects. The concentration of cortisol in plasma is not a measure of adequate physiological stress due to the dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis during critical illness. Therefore, the objective of this study is to assess the levels of accumulated cortisol in human hair (CHH) during the different stages of the critical illness and its recovery, as well as to explore its relationship with the functional and neuropsychological sequelae observed in the ICU survivors.

A prospective pilot study has been proposed in 50 critical patients with\> 24 hours of mechanical ventilation. CHH levels will be recorded at admission, 1 month and 1 year after ICU discharge. In all survivors, the presence of delirium will be assessed during the ICU stay and the functional, cognitive and psychological status will be assessed at short (1 month after ICU discharge) and long term (1 year after ICU discharge).

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with \>24hours of mechanical ventilation

Exclusion Criteria:

* Previous neurological and/or psychiatric pathology
* Sensory alterations that prevent the application of the neurocognitive tests
* Cognitive impairment prior to ICU admission (Score \>57 in the Short Form of the Informant Questionnaire on Cognitive. Decline -Short IQCODE-)
* Sever alopecia
* Rejection of voluntary participation
A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74

This is a gene transfer therapy study evaluating the safety of and delandistrogene moxeparvovec dystrophin protein expression from delandistrogene moxeparvovec following therapeutic plasma exchange (plasmapheresis) in ambulatory male participants with DMD and pre-existing antibodies to AAVrh74 over a period of 58 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory per protocol specified criteria.
* Has a definitive diagnosis of DMD prior to Screening based on documentation of clinical findings and prior confirmatory genetic testing.
* Ability to cooperate with motor assessment testing.
* Has elevated AAVrh74 antibody titers per protocol-specified requirements.
* A pathogenic frameshift mutation, nonsense mutation or premature stop codon or pathogenic variant in the DMD gene that is expected to lead to absence of dystrophin protein with exception of a mutation in exon 8 and/or 9.
* Stable daily dose of oral corticosteroids for at least 12 weeks prior to Screening, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight).

Exclusion Criteria:

* Has reduced left ventricular ejection fraction on the screening ECHO or clinical signs and/or symptoms of cardiomyopathy.
* Presence of any other clinically significant illness, including cardiac, pulmonary, hepatic, renal, hematologic, immunologic, or behavioral disease, or infection or malignancy or concomitant illness or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risks for gene transfer or a medical condition or extenuating circumstance that, in the opinion of the Investigator, might compromise the participant's ability to comply with the protocol required testing or procedures or compromise the participant's wellbeing, safety, or clinical interpretability.
* Exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits.
* Abnormality in protocol-specified diagnostic evaluations or laboratory tests. .

Note: Other inclusion or exclusion criteria could apply.
PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing

The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial workup and follow-up of patients treated with 177Lu-PSMA in mCRPC.

Prostate-specific membrane antigen (PSMA) is expressed in most metastatic castration-resistant prostate cancer (mCRPC) cells. In response to this finding, a vectorized internal radiotherapy (VIR) therapy was developed, lutetium 177-labeled PSMA, 177Lu-PSMA. Clinical trials have demonstrated its efficacy in men with metastatic castration-resistant prostate cancer . The number of patients treated in nuclear medicine departments has increased considerably in recent years, notably with the Food and Drug Administration's (FDA) and the European Medicines Agency's (EMA) approval of this treatment (177Lu-PSMA-617, Pluvicto®) in the setting of progressive mCRPC after at least one line of 2nd-generation hormone therapy and one line of taxane chemotherapy.

Patients eligible for treatment benefit from pre-therapy 68Ga-PSMA positron emission tomography (PET/CT) to assess PSMA expression by cancer cells, but 18FDG PET/CT, although mentioned in the EANM guidelines, is not routinely performed. For treatment follow-up of prostate cancer patients, the PCWG3 (prostate cancer working group 3) currently recommends conventional imaging (CT scan and bone scan) (4) and makes no mention of metabolic imaging, even though some lesions are not detectable with conventional imaging. In addition, one study reported that a high metabolic volume 18FDG PET/CT scan as part of the pre-therapy work-up for mCRPC prior to the introduction of 177Lu-PSMA or Cabazitaxel therapy was associated with a poorer response to treatment.

The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial work-up and follow-up of patients treated with 177Lu-PSMA in mCRPC.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with 177Lu-PSMA for castration-resistant prostate cancer at Nancy University Hospital
* Patients with 68Ga-PSMA and 18FDG PET scans as part of the initial workup and treatment follow-up

Exclusion Criteria:

* Patients who did not give their consent to use their data retrospectively