cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population

This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.

A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018.

The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP will be used to collect digital images..

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborns with or without signs of jaundice
* Gestational age \>35 weeks
* Age 0-14 days
* Birth weight \> 1500 g.
* Parents acceptance of their children to participate in the study.
* Newborn needing a blood test

Exclusion Criteria:

* Newborns showing signs or with diagnosis of inborn diseases
* Newborn transferred to pediatric ward for any treatment
* Newborns who had received phototherapy.
Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study

The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised

  * vesicular lesion of undetermined significance
  * follicular neoplasm or Hurthle cells
  * lesion suspicious for malignancy
* Confirmation of indeterminate cytology (IC) replay centralized
* Patient affiliated to a social security scheme
* Informed consent and signed

Exclusion Criteria:

* Thyroid node \<15 mm
* Nodules coalescing preventing proper individualization of targeted nodule
* Indeterminate cytology older than six months
* Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology
* Major subject to a measure of legal protection or unable to consent
* Refusal to participate
MOTIVOB-(Acceptance and Commitment Therapy Group Intervention for Obesity)Section

The purpose of the present study is to compare an Acceptance and Commitment Therapy (ACT) group intervention and a Cognitive Behavioral Therapy (CBT) group in a sample of obese individuals with respect to mid-term outcome.

Effective weight-management programs often include a combination of physical activity, diet, and psychological intervention, in particular Cognitive Behavioral Therapy (CBT). The effects of these programs are frequently not stable, and usually the maintenance of achieved weight-loss lasts only for a short period of time. Acceptance and Commitment Therapy, ACT, keeps on gaining recognition in obesity treatment. The purpose of the study is to compare weight loss and indicator of psychological functioning in a population of obese subjects belonging to three different diagnostic categories: without ED, with ED NAS and with BED. Participants were exposed respectively to a CBT or an ACT treatment and were assessed three times: pre intervention, post intervention and follow-up. The investigators hypothesize that CBT and ACT are both effective in the post-intervention. ACT intervention should be more effective in the follow-up both for weight and psychological functioning, due to its focus on the flexible managing of the global context instead of the focus on the pathology itself, more typical in standard CBT treatment.

Eligibility Criteria:
Inclusion Criteria:

1. between the ages of 18 and 70 years
2. obesity according to the WHO criteria (BMI ≥ 30)
3. fluency in spoken and written Italian language
4. expression of written informed consent

Exclusion Criteria:

1. other severe psychiatric disturbance different form eating disorders diagnosed by DSM-5 criteria (SCID-Structured Clinical Interview for DSM-IV-TR Disorders I and II and DSM 5 manual, administered by an independent clinical psychologist, were used as screening tools for psychiatric disorders)
2. concurrent severe medical condition not related to obesity
The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis

The aim of the work is to determine whether the use of immunomodulatory drugs could improve the reproductive of outcome of infertile patients who have autoimmune thyroiditis with positive autoimmune antibodies undergoing IVF-ET.


Eligibility Criteria:
Inclusion Criteria:

* Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.

Exclusion Criteria:

* All patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease.

Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ....)
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied


Eligibility Criteria:
Inclusion Criteria:

* 2-18 years of age
* Group A: Lamivudine naive (\<1 week of Lamivudine) and not within 24 weeks of screening; Group B: Lamivudine experienced (\> 12 weeks of Lamivudine); Group C: nucleoside/nucleotide experienced (\> 12 weeks of nucleoside/tide therapy) added as a country-specific protocol amendment (not all sites had Group C).
* HBV Deoxyribonucleic acid (DNA) ≥ 100000 copies/mL; ≥ 10000 copies for nucleoside/nucleotide experienced (Group C)
* Detectable Hepatitis B surface antigen (HBsAg) for 24 weeks prior to screening
* Hepatitis B e antigen (HBeAg) positive
* Compensated liver and renal function
* Elevated alanine aminotransferase (ALT) at screening and during the 24 weeks prior to screening (for Groups A and B)

Exclusion Criteria:

* Coinfection with Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis D Virus (HDV)
* Children who were breastfed while their mother received Lamivudine, or children whose mothers received Lamivudine during pregnancy
A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users

This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers, 18 to 55 years of age inclusive
* Recreational drug abuse experience (\>/= 10 times lifetime abuse of a CNS depressant, \>/= 1 abuse of CNS depressant in the previous 3 months
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Main study (Part 2): Able to differentiate between diazepam and placebo

Exclusion Criteria:

* History of any significant disease or disorder
* History or current diagnosis of substance dependence (excluding caffeine and nicotine)
* Currently seeking or history of participating in treatment for substance-related disorders, including successful completion of such treatment
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or lactating women
* Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
* Confirmed positive drug screening at screening / any Day -1 (allowed positive THC at screening and any Day -1 and positive benzodiazepine at screening only)
* Positive alcohol breath test at screening / any Day -1
* Heavy smoker (\> 20 cigarettes, \> 8 pipefuls or \> 8 cigars per day)
A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function

The study looks at the blood levels of a new study medicine in people with normal and impaired kidney function. Participants will get the study medicine called NNC0174-0833. This is an experimental medicine and has not been approved by the US FDA. It is being developed as a new medicine for weight management. Participants will get 1 injection of the study medicine by a study nurse at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 9 weeks. Participants will have about 7 visits with the study staff or the doctor. At the visits, participants will have clinical checks done and blood samples taken. Participants will be collecting their urine several times during the study. Participants will be asked about their health, medical history and habits. People who are already in another research study cannot take part. Only women who are not able to become pregnant can take part in the study. Only men who do not plan to father a child during the study or 6 weeks following the dose administration can take part in the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential, aged 18-80 years (both inclusive) at the time of signing informed consent.
* Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
* For subjects with normal renal function: eGFR of equal to or above 90 mL/min
* For patients with mild renal impairment: eGFR of 60-89 mL/min
* For patients with moderate renal impairment: eGFR of 30-59 mL/min
* For patients with severe renal impairment: eGFR of \<30 mL/min not requiring dialysis

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Use of prescription or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect subject safety or the results of the trial.
Effect of Nitrate on Red Blood Cell Function in Type 2 Diabetes

To investigate the effect of nitrate supplementation on red blood cell function in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes

Exclusion Criteria:

Acute coronary syndrome Vegetarian diet Impaired renal function Absolute indication for proton pump inhibitor Ongoing treatment with organic nitrate Heart failure (ejection fraction \<35%) Any condition that interferes with the possibility to fulfill the study protocol
A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation

The purpose of this study is to assess the impact of different parameters (voltage, pulse width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms in patients with Parkinson's disease (PD).

In this observational study, we will retrospectively analyze the one-year follow-up data of 27 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University in the years 2008-2012. The data, including parameter settings and severity of motor symptoms indicated by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores, was collected during the patients' annual visit to the hospital for reprogramming. A correlation analysis will be conducted to investigate the relationship between change of a specific parameter and the subsequent change of motor scores.

Eligibility Criteria:
Inclusion Criteria:

* PD patients treated with bilateral STN DBS in the First Affiliated Hospital in the years 2008-2012

Exclusion Criteria:

* Simultaneous participation in another clinical trial
* Dementia (Mini Mental State Examination \< 26)
* Removal of DBS electrodes
* Loss to follow-up
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.


Eligibility Criteria:
Inclusion Criteria:

* Subject suffering from generalized prurigo nodularis
* Have demonstrated pruritus intensity during screening
* Male or female who are at least 18 years old at the time of consent

Exclusion Criteria:

* Subject has chronic pruritus resulting from other conditions
* Subject has a history of substance abuse within the past year
* Subject has a known drug allergy to opioids
* Subject is a pregnant or lactating female
Cannabinoids for Pain Control During Medical Abortion

The objective of this study is to determine if a synthetic cannabis derivative, dronabinol, in addition to ibuprofen, decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion. Results of this study will help providers counsel patients regarding cannabis use during medical abortion.

This is a randomized, double-blind, placebo-controlled trial comparing pain levels in women undergoing medical abortion with one of two regimens: ibuprofen 800mg and a 5mg oral dronabinol versus ibuprofen 800mg and placebo given at the time of misoprostol administration. This study will include 62 women undergoing medical abortion. Women will be randomized to dronabinol 5mg oral versus placebo. The primary outcome will be maximum reported pain score within 24 hours of misoprostol administration.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years or older
* Consented for elective medical abortion
* Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
* Able and willing to receive text messages via phone
* English speaking
* Able and willing to give informed consent and agree to the study terms
* Have assistance at home; no motor vehicle use while taking study medications

Exclusion Criteria:

* Desires to continue pregnancy or currently breastfeeding
* Lack of access to cell phone and texting capabilities
* Prior participation in this study
* Early pregnancy failure
* Contraindications to the study medications: Marinol or marijuana derivatives, sesame oil, Ibuprofen
* Contraindications to medical abortion with Mifepristone or Misoprostol
* History of methadone, buprenorphine or heroin use within the last year
* History of a seizure disorder
* Used marijuana 5 or more days in the last week
* History of any adverse effects associated with prior use of recreational or medical marijuana products, or sensitivity/allergy to Marinol.
A Study of SPY002-072 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-072 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits

Exclusion Criteria:

* Participation in more than one cohort
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, cannabis/cannabinoid use, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
* History of severe allergic reactions or hypersensitivity
* Donation or loss of ≥ 1 unit of whole blood within 1 month prior to dosing
Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
* Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
* Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

* Significant neurological disease other than Alzheimer's Disease
* Major psychiatric disorder
* Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
* Women of childbearing potential
Brief Cognitive Behavioral Therapy Versus Crisis Intervention Therapy Through Telepsychiatry on Psychiatric Symptoms

The purpose of this randomized controlled trial is to determine the effect of two behavioral interventions: brief cognitive-behavioral therapy and crisis intervention therapy through telepsychiatry, over the level of perceived stress, anxiety, depression and post-traumatic stress symptoms during the COVID-19 pandemic in medical residents and medical staff at three hospitals in two cities of Honduras.

The psychotherapeutic interventions are going to be delivered from June to August at each participating center. Subjects will be allocated randomly in each of the two interventional arms independently by stratification in each participating center. The population for intervention will be medical staff from three different national hospitals in the frontline during the pandemic. After valid informed consent, a screening process will take place to identify symptoms as baseline evaluation using validated self-assessment tools delivered through electronic invitation. Post-intervention measurements will take place at 3 and 6 months from baseline. Intention to treat analysis and per-protocol analysis will take place. CONSORT guidelines were followed.

Eligibility Criteria:
Inclusion Criteria:

* Medical doctors and medical residents 18 years and older, from UNAH medical school and Hospital de Occidente.
* Medical doctors and medical residents whom during the initial screening show positive scores in Patient Health Questionnaire-2 and Generalized Anxiety Disorder scale-2
* Access to internet and an electronic device

Exclusion Criteria:

* Medical doctors and medical residents referring a history of psychiatric disorders
* Medical residents that belong to the Psychiatry Residency Program
* Medical residents and medical doctors that have been diagnosed with COVID-19
* Medical doctors and residents whom during evaluations show severe symptoms of depression, anxiety and post-traumatic stress symptoms
* Medical doctors and residents with negative screening in Patient Health Questionnaire-2 and Generalized Anxiety Disorder Scale-2
* Participants that do not have access to internet connection or an electronic device.
Effects of Melatonin and Massage After Third Molar Surgery

Lymphatic drainage massage is an important practice, especially for reducing edema. It is a very gentle, monotonous, slow, rhythmic massage applied to the skin surface. It accelerates the flow of lymph fluid and provides comfort by minimizing swelling. Lymphatic drainage massage, which is frequently used after impacted third molar surgery, helps reduce edema and increases patient comfort during the postoperative period.

Melatonin, a hormone produced by the pineal gland, is a neurochemical substance that works in harmony with the body's natural rhythm. In addition to the brain, it is found in the retina, bone marrow, intestines, skin, and various blood cells. Conditions such as insomnia or jet lag may benefit from melatonin supplements. Besides contributing to sleep quality, melatonin may also assist in regulating the immune system, body temperature, blood pressure, and cortisol hormone levels.

Another important function of melatonin is that it is a very powerful free radical scavenger. Melatonin can neutralize both reactive oxygen species and reactive nitrogen species. It is also known to capture highly toxic hydroxyl radicals, peroxynitrite anions, and peroxyl radicals. In some cases, melatonin inhibits nitric oxide synthase, a prooxidant enzyme. Additionally, it stimulates the mRNA levels of superoxide dismutase enzyme and is known to activate glutathione peroxidase, glutathione reductase, and glucose-6-phosphate dehydrogenase. After reacting with the hydroxyl free radical (OH•), melatonin transforms into an indolyl cation radical, which is noted to capture the superoxide radical (O2 · -) in the environment and exhibit antioxidant activity. Due to this powerful antioxidant property, its effects on pain and edema have been investigated in some studies. In these studies, pre-op/post-op melatonin application has been shown to reduce postoperative pain and accelerate sensory healing due to melatonin's antioxidant effects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients need for removal surgery of impacted third molars.
2. Patients without systemic diseases.

Exclusion Criteria:

1. Presence of systemic diseases affecting general health.
2. Presence of a malignant disease in the head and neck region.
3. Patients with any bleeding disorders.
4. Patients with cardiovascular diseases or those undergoing anticoagulant or antiplatelet therapy.
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).

The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper).

The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks).

Study Hypothesis:

Comparison(s):

Eligibility Criteria:
Inclusion Criteria:

Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)

(1) Patients meeting all of the following inclusion criteria

1. Patients of at least 20 years of age
2. In- or outpatients of either sex.
3. Patients in any stage on the modified Hoehn and Yahr severity scale

Exclusion Criteria:

* Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.
* Patients with subjective symptoms derived from orthostatic hypotension.
* Patients with hypotension (systolic blood pressure \<100 mmHg)
* Patients with concomitant illness such as severe cardiac, renal, and hepatic disease
* Patients with a current or past history of epilepsy
* Pregnant, possibly pregnant, or lactating women
* Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study.
* Patients who judged incompetent to give consent
* Others judged by the investigator or co-investigator to be ineligible as subjects.