cyrilzakka/clinical-trials huggingface dataset:
Melatonin as Adjuvant Treatment for ADHD in Adults

This study aims to evaluate the effect of melatonin supplementation as adjuvant treatment in ADHD in adults.


Eligibility Criteria:
Inclusion Criteria:

Male and female age 18-60 inclusive. Primary diagnosis of ADHD AISRS total score ≥ 24 CGI-S ≥4 (moderately ill or worse). Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.

Has given written informed consent to participate in the study.

Exclusion Criteria:

BMI less than18.5 or greater than 35. Any underlying/ history or current diagnosis of systemic and/or metabolic disease (e.g. diabetes, Crohn's disease) and/or neurological condition state that may render the subject illegible to participate in the study as assessed by medical history, physical exam, clinical and lab evaluation.

History of uncontrolled hypertension or a resting systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg (Subjects with well controlled hypertension on a stable dose (2 months) of anti-hypertensives will be allowed to participate).

Major depression or anxiety disorder which is a focus of treatment or requires taking medication.

A lifetime history of psychosis or bipolar disorder Has any concurrent chronic or unstable medical condition that could confound with the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.

Subjects taking any medication with CNS effects Subjects with a history of two or more prior failed adequate trials of ADHD treatment due to adverse events.

Use of dietary supplements with potential CNS effect, including omega-3 supplements, 30 days before study initiation and throughout the study.

Clinical history of cognitive impairment in judgment of investigator. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to randomization. Women of childbearing potential must agree to use adequate birth control for the entire duration of the study.

Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or drug abuse or dependence (excluding nicotine).

Has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.

Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.

Previous use of melatonin or melatonin analogues
Radial and Focused ESWT in the Treatment of Coccydynia According to Age and Body Mass Index

To date, focused and radial types of ESWT have been effectively used in the treatment of coccydynia. However, studies directly addressing a comparison between radial and focused types of ESWT in coccydynia have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on coccydynia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* Malignancy
* Those who have received ESWT treatment before
* Pediatric patients
* Patients with infection.
Positron Emission Tomography (PET) During Radio-chemotherapy to Treat Otorhinolaryngological Cancer

Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 75 years
* invasive epidermoid carcinoma of head and neck (excluding nasopharyngeal), confirmed by histology
* locally advanced disease (non-metastatic stages AJCC III-IV). AJCC = American Joint Committee on Cancer
* performance status ECOG ≤ 2. ECOG = Eastern Cooperative Oncology Group
* no history of irradiation of the head and neck
* start of radiotherapy within 8 weeks after the pretreatment PET Scan
* no surgery other than biopsy
* pregnancy test: negative for women of childbearing potential
* reliable contraception for a childbearing couple, men and woman must have a reliable contraception during treatment
* signed informed consent form
* patient with national health insurance

Exclusion Criteria:

* prior radiotherapy or chemotherapy
* history of other cancer except: cutaneous non-melanoma tumor and cervix in situ carcinoma
* unstable conditions (cardiovascular, renal, pulmonary) or systemic (lupus erythematosus, scleroderma)
* pregnant patient or patient with breastfeeding
* patient unable to give his consent
* patient under administrative supervision
* patient who participates to another clinical trial on experimental drug
* regular follow-up impossible for various reasons (familial, economical, social, ...)
* diabetes
* accelerated radiotherapy protocol
The Role of 5% Lidocaine Patches in the Pain Control of Hepatocellular Carcinoma Patients Receiving Radiofrequency Ablation

Background: This study aims to test whether 5% lidocaine patches can reduce Radiofrequency ablation-induced pain. Methods: The study will enroll patients with hepatocellular carcinoma and schedule a radiofrequency ablation procedure. 200 patients will be invited to allocate randomly into study or control groups: pretreatment with a 5% lidocaine patch (LidotopⓇ) (Group A); pretreatment with a placebo patch (Group B); The skin patch is applied before Radiofrequency ablation (RFA) while admission, and is changed every day till discharge. Pain severity is evaluated by a visual analog scale using a 10-point scale recorded by a study nurse before RFA and after the procedure. The demographic data, hepatocellular carcinoma characteristics, analgesics usage, patient satisfaction with pain control, and visual analog scale will be compared between the two groups. Anticipated results: Pretreatment with 5% lidocaine patches is an effective and straight method of reducing Radiofrequency ablation-induced pain to reduce analgesics usage and improve patient satisfaction with pain control.


Eligibility Criteria:
Inclusion Criteria:

1. Adults diagnosed with liver cancer (HCC) by a physician and eligible for radiofrequency cautery (RFA).
2. Age is \> = 18 years.
3. Whether there is cirrhosis combined with cirrhosis, the child-pugh score of those with cirrhosis must score \< 8 points.
4. Communicative and able to express pain sensations.

Exclusion Criteria:

1. Those who are allergic to Lidocaine.
2. Those who suffer from skin diseases or have wounds on the abdomen that cannot be patched.
The Correlation Study of Hypnotic Drugs on the Cognitive Function of Patients With Chronic Insomnia.

All the subjects were assessed for sleep quality, anxiety and depression, and cognitive function. Based on their previous hypnotic medication history, they were divided into a non-medicine group and a benzodiazepine group，and the group taking non-benzodiazepine drugs.The cognitive effects of different hypnotic drugs on patients were evaluated by comparing sleep related scale and cognitive function scale.

Insomnia is one of the most common sleep disorders, with 38.2% of Chinese people suffering from sleep disorders. There are many ways to treat insomnia disorders, but drug therapy is the most commonly used method by medical staff. The cognitive effects of sleep drugs vary in numerous studies, depending on the type and dosage of drugs.This study aims to explore the effects of different types of hypnotic drugs on the treatment of insomnia and cognitive function, hoping to improve the sleep quality and living standards of insomnia patients through this study, and also to obtain some cognitive impairment prevention measures related to insomnia, to provide some theoretical basis for clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, male or female ≥18 and ≤75 years old;
2. (ICSD-3) proposed the diagnostic criteria for chronic insomnia;

2. Did not take hypnotic drugs before the visit; 3. Those who took hypnotic drugs before the visit; 4. Can understand and comply with the study protocol;

Exclusion Criteria:

1. Severe organic disease;
2. Any suicidal behavior in the past 10 years;
3. Those who cannot communicate normally cannot cooperate to complete the scale test;
4. Women who are breastfeeding or pregnant;
5. Medical history that the investigator believes could affect the safety of the subject or interfere with the study evaluation;
6. Currently diagnosed with sleep apnea, narcolepsy and other sleep disorders;
7. Sleep disorders caused by central nervous system diseases, or neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, lewy bodies dementia.
Progressive Tension Sutures in Gender Affirming Mastectomy

50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.


Eligibility Criteria:
Inclusion Criteria:

1. Being consulted for gender affirming mastectomy with the senior author (AH).
2. \>18 years of age at the time of enrollment.
3. Transgender or gender nonbinary gender identity.
4. All co-morbidities and all indications.

Exclusion Criteria:

1. Age less than 18 years.
2. BMI \< 23.
Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors

RATIONALE: Diagnostic procedures, such as optical spectroscopy, may help learn the extent of disease and allow doctors to plan better treatment.

PURPOSE: This phase I trial is studying optical spectroscopy to see how well it works in evaluating tumor margins in patients who have undergone surgery for breast cancer.

OBJECTIVES:

* To develop a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures.
* To conduct an ex vivo optical spectroscopic study in operating rooms on breast tissue samples obtained immediately following resection to assess the efficacy of using this tool in differentiating breast tumor or tumor margins from normal breast tissue.

OUTLINE: Breast tissue samples obtained immediately following resection are examined in the operating room using optical spectroscopy to evaluate the margin tissue. During spectroscopy, all lights, except for the surgical lights, are turned off and the lateral, superior, medial, inferior, deep, and anterior margins of the breast tissue sample are examined using a fiber-optic probe, a nitrogen laser, and a broad band white light source. Reflectance and fluorescence spectra are measured at each of these margins by a system operator. The measured margins are then immediately marked by sutures placed by the surgeon. Additional margins may be measured at the surgeon's and system operator's discretion. The breast tissue sample is then delivered to surgical pathology, where shave biopsies are performed at the suture-marked sites to provide a direct correlation between spectroscopy measurements and tissue pathology.

Data collected in this study, including spectral data, gross diagnosis of the patient's tumor, and histological identities of all specimens collected, will be kept in the research record for at least 6 years after the study is finished.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Scheduled to undergo lumpectomy, partial or radical mastectomy, or excisional biopsy for breast tumor at Vanderbilt University Hospital
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Male or female
* Menopausal status not specified
* Not pregnant

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

INCLUSION CRITERIA Only adult patients between the ages of 18-99 years with breast tumor undergoing lumpectomy, radical mastectomy or excisional biopsy procedure will be considered

EXCLUSION CRITERIA Pregnant women will be excluded from the participation.
Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy

The purpose of this study is to evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel at any point between the 1st day of the 27th week of gestation up to the end of pregnancy and their offspring (ie, Adacel-exposed cohort), in comparison with pregnant individuals not vaccinated with any Tdap vaccines during pregnancy and their offspring (ie, Tdap-unvaccinated comparator cohort).

The primary objectives are to estimate incidence rates and relative risks for each prespecified pregnancy outcome in Adacel-exposed and Tdap-unvaccinated comparator cohorts and for each prespecified adverse birth outcome in the offspring of both cohorts.

The secondary objectives are to estimate incidence rates and relative risks for each prespecified adverse fetal and neonatal outcome in the offspring of Adacel-exposed and Tdap unvaccinated comparator cohorts and for each prespecified adverse outcome for pregnant individuals in both cohorts.

Study outcomes to be assessed in electronic medical records between January 2016 to December 2025.

Eligibility Criteria:
Inclusion Criteria:

* For pregnant individuals:

  * Continuous enrollment, with no more than a 1-month administrative gap from 90 days prior to their last menstrual period (LMP)
  * Continuous enrollment for the duration of their pregnancy through delivery or termination of pregnancy (or 6 weeks postpartum for preeclampsia/eclampsia and 28 days for PPH) unless censored at death in order to capture study outcomes
  * At least 1 prenatal visit prior to 27 weeks of gestation during pregnancy
* For offspring:

  * Infants delivered by pregnant individuals who meet all the inclusion criteria above
  * With gestational age as calculated based on date of birth recorded in the EMR

Exclusion Criteria:

* For pregnant individuals:

  * Loss of pregnancy or with delivery before 27 weeks of gestation
  * Vaccinated with Boostrix® (Tdap vaccine, GSK), or with an unknown brand of Tdap vaccine, or Td (tetanus, diphtheria) vaccine during pregnancy
  * Vaccinated with any Tdap vaccine prior to the ACIP recommended optimal timeframe of ≥ 270/7 weeks of gestation
  * Received more than one Tdap vaccine during pregnancy
  * Vaccinated with one or more live vaccines during pregnancy
  * Pregnant individuals with multiple gestation pregnancies (eg, twins, triplets)
* For offspring:

  * Infants delivered by pregnant individuals who meet any of the exclusion criteria above
Medical Imaging Characteristics of Patient With Unclassified Acute Cervical Pain

Some cases of acute antero-lateral cervical pain cannot be accurately classified by medical imaging (ultrasound and/or magnetic resonance imaging and/or CT-scan) : imaging rules out carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes and thus the pain is considered "of unknown origin".

The investigators hypothesize that in such cases perivascular inflammation of the carotid may be involved.

This study aims at systematically reviewing medical files (including imaging) of patients suffering from acute cervical pain in which carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes have been ruled out by ultrasound and/or magnetic resonance imaging and/or CT-scan


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with acute cervical pain
* Presence of at least one medical imaging modality of the neck : ultrasound with doppler imaging, magnetic resonance imaging, CT-scan
* Medical imaging of the neck includes dedicated vessel analysis
* Absence of definite diagnosis for the cause of the pain after imaging

Exclusion Criteria:

* Musculoskeletal cause of the pain
* Carotid dissection
* Carotid occlusion
* Carotid vasculitis
Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation

THE OBJECTIVE OF THE RESEARCHERS IS TO DETERMINE WALKING, BALANCE, FALL RISK AND KINESIOPHOBIA IN INDIVIDUALS WITH ALZHEIMER'S DEMENTATION.

The gait, balance, fall risks and kinesiophobia of individuals with Alzheimer's Dementia will be evaluated and compared with healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* INDEPENDENT walker diagnosed with Alzheimer's Dementia

Exclusion Criteria:

* Having a disability to do physical activity Those who have had an operation in the last 6 months
Construction and External Validation of a Predictive Clinico-biological Score of the Risk of Venous Thrombosis in Women Under Combined Oral Contraceptives

the investigators hypothesize that some of these polymorphisms contribute to VTE risk in women using COC, and that their screening could to help assess individual risk of VTE before COC prescription.

In order to test this hypothesis the investigators propose to build a predictive score for VTE in women using COC based on clinical and biological factors. To this end the investigators have a large case study (including 766 patients) recruited at the "Centre d'Exploration des Pathologies Hémorragiques et Thrombotiques" (CEHT) of the laboratory of Hematology (La Timone Hospital, Marseille) between 2003 and 2013. The cases had a personal history of documented VTE while using COC (PILGRIM study). A great number of clinical and biological relevant phenotypes in the field of VTE have already been collected (including 14 polymorphisms selected on the basis of their biological plausibility and the existence association studies).To our knowledge it is the largest study specifically conducted in order to assess genetic factors associated with VTE in women using COC. These 766 cases will be compared to 766 controls from the general population (cohort Nutrinet-Santé). Then, the predictive values of the score will be assessed in an independent multicentric validation study that the investigators will set up in the field of this project. Our study should allow a better understanding of the genetic and environmental factors involved in VTE related to COC use. Besides, this project aims to respond to a major public health issue giving an effective tool for the decision of prescribing COC.


Eligibility Criteria:
Inclusion Criteria:

* Women who had an episode of documented VTE (deep vein thrombosis and / or pulmonary embolism) under COC who consulted in a specialized counseling center.
* Women of age.
* Subject agreeing to participate in this research, having signed informed consent.

Exclusion Criteria:

* Absence of COC,
* No knowledge of the COC generation used by the patient,
* Undocumented MTEV Episode
* Absence of available sample (DNA),
* Refusal to participate in the study
Safety Study of the VEGA UV-A System to Treat Keratoconus

The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older
* Having a diagnosis of keratoconus
* Presence of central or inferior steepening
* Topography consistent with keratoconus
* Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
* Contact lens wearers only:Removal of contact lenses for the required period of time
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
* Corneal pachymetry ≤ 400 microns
* Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
* A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
* A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
* Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Patients Who Receive 131 I-MIBG

This study is for patients who have have neuroblastoma, pheochromocytoma, or paraganglioma that has come back (relapsed) after treatment or has not gotten better (refractory) with standard treatment. The purpose of this study is to evaluate quality of life and response rate to 131 I-MIBG treatment.

This is an observational, single institution study designed to determine the benefit of 131I-MIBG therapy in subjects with refractory, relapsed or progressive neuroblastoma, malignant pheochromocytoma or paraganglioma, or other neuroendocrine tumors. Response rate, time to progression, and quality of life changes will be evaluated.

Eligibility Criteria:
Inclusion Criteria

Subject must meet all of the following applicable inclusion criteria to participate in this study:

1. Written informed consent, and assent where applicable, and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
2. Age greater than or equal to 1 years and less than or equal to 30 years at the time of therapy.
3. Subject is scheduled to receive 131 I-MIBG therapy.
4. Diagnosis of refractory, progressive or relapsed Neuroblastoma, Malignant Paraganglioma, Malignant Pheochromocytoma or other Neuroendocrine Tumors.
5. As determined by the enrolling physician, ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria

Subjects meeting the criteria below may not participate in the study:

1. Prior enrollment on LCI-PED-NEU-MIBG-001 trial.
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

Stribild is a preferred regimen in the Department of Health and Human Services guidelines and has demonstrated non-inferiority to Atripla in treatment naïve patients out to 144 weeks (GS-102). Stribild also has statistically significant less Central Nervous System side effects, sleep disturbances and lipid elevations compared to Atripla. This study will evaluate the efficacy, safety, changes in Central Nervous System abnormalities and sleep disorders following a switch from virologically suppressed subjects on Atripla to Stribild.

Eligibility Criteria:
Inclusion Criteria:

* HIV+ subjects 18 years of age or older
* estimated Glomerular Filtration Rate \> 70 mL/min
* must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral Load \< 50 copies/mL
* no antiretrovirals prior to the initiation of Atripla
* baseline genotyping

Exclusion Criteria:

* pregnancy
* unable to provide informed consent
* enrolled in another study