cyrilzakka/clinical-trials huggingface dataset:
Distress Tolerance for Benzodiazepine Discontinuation

The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.

This study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol. The Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention consists of 13 weeks with 5 weekly therapy sessions prior to a 9-week BZD taper. Some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using BZDs \[e.g. selective serotonin reuptake inhibitors (SSRI) for anxiety or hypnotics for insomnia\]. Data collection will occur at baseline, then weekly for 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Receiving OAT (methadone or buprenorphine) for at least 2 weeks
* Regular BZD use defined by BZD use 3 or more times per week in past month by self-report and positive urine screen at time of recruitment
* Provides permission to contact current BZD prescriber if being prescribed BZDs
* Speaks English
* Wants to discontinue BZD use
* Capacity to provide informed consent

Exclusion Criteria:

* Pregnant, confirmed by urine pregnancy test
* Cognitive impairment, as indicated by Montreal Cognitive Assessment (MoCA): must score at least 26 on the MoCA with a one-point adjustment for individuals with formal education of 12 years or fewer
* Any past month illicit opioid determined by self-report or urine drug test; illicit defined as non-medical use
* Receiving ongoing psychosocial treatment for BZD use disorder
* Uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past BZD withdrawal seizure
* Current suicidality or homicidality
* Current psychotic symptoms
CAR-T for R/R B-NHL

This study is a single arm study to investigate the efficacy and safety of CAR-T targeted CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for at least 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Histological detection confirmed CD19/CD20/CD22/CD30 postive non-Hodgkin lymphoma
* Recieved more than 2 lines of chemotherapy
* With contraindications of hematopoietic stem cell transplantation or relapse after hematopoietic stem cell transplantation
* Expected survival more than 3 months
* Karmofsky performance score ≤ 60, and ECOG ≥ 2.
* Enough organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT \< 2 × upper limitation of normal; SpO2 \> 92%
* CBC results: Hb ≥ 80g/L, ANC \> 1 × 10E9/L, Plt ≥ 50 × 10E9/L
* Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
* With measurable disease
* Written informed consent could be acquired

Exclusion Criteria:

* Received immunol suppression treatment or steroids in recent 1 week before recruitment
* Uncontrolled infection
* HIV positive patients
* Active HBV or HCV infection
* Women in pregnancy and lactation
* Refuse to conception control during treatment and 1 year after CAR-T infusion
* Uncured malignancies other than non-Hodgkin lymphoma
* Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma
* Inheritated immune deficiancy
* Severe heart disease
Improving Access to Renal Transplantation for Underserved Black Communities

The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are:

Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant? Does the AATAP intervention have an effect on Black patient self-efficacy and trust in care team?

Researchers will compare kidney transplant listing status after 12 months of patients in the AATAP intervention to usual care patients to see if the AATAP program increases the number of patients listed for transplant.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as Black or African American;
* 18 to 75 years of age
* have an eGFR \< 20 or End Stage Renal Disease Diagnosis;
* screen positive for AATAP via the screener (for poor health literacy or poor medical adherence or psychosocial concerns);
* medically eligible to begin transplant evaluation process determined by transplant team

Exclusion Criteria:

* other racial groups
* participants who have previously received a transplant;
* pregnant women;
* participants who screen negative on the screener;
* children less than 18 years old
Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age 18 years or older
* Any ethnicity
* Are undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy
* Is able to provide informed consent.

Exclusion Criteria:

* Pregnancy
* Lactation
* Women who are unable or unwilling to understand or to provide informed consent
* Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
* Women who are unable to tolerate study constraints.
* Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to):
* Treatment for enlarged thymus gland as an infant
* Irradiation for benign breast conditions, including breast inflammation after giving birth
* Treatment for Hodgkin's disease
* Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to):
* Tuberculosis
* Severe scoliosis
Does Melatonin Restore Sleep Architecture in Autistic Children

Although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. Results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. Others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation.

Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders.

Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders.

It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time...), but on sleep quality (number of nocturnal awakenings).

The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects.

The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls from 3 to 12 years old with autism spectrum,
* Diagnosed by psychiatrists according to the diagnostic criteria for autism ICD-10 AND ADI or ADOS positive,
* With trouble sleeping, assessed by questionnaire CHSQ,
* Having made a night polysomnography,
* Written informed consent (signed by parents),
* Affiliated with the French universal healthcare system.

Exclusion Criteria:

* Children who stopped all treatment for sleep for less than one month,
* Liver or kidney insufficiencies,
* Acute illness during or occurred in the month preceding the study,
* Neurological disease without autism spectrum , patients with non-controlled epilepsy
* Health background witch can influence sleep (other than autism itself),
* Obstructive syndrome (history - oral breathing in wakefulness, nocturnal snoring significant (heard the door closed), nocturnal respiratory effort, apnea reported by parents- and clinical examination (chronic nasal congestion, large tonsils and touching),
* Known hypersensitivity to the active substance or to one of the excipient contained in the verum or in the placebo,
* Children under treatment against-indicated with the study treatment witch can't be stopped
The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.

In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.

Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.

The endpoints will be :

Primary endpoint:

• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.

Secondary endpoints:

* Change in pain intensity measured by visual analog scale (VAS).
* Improvement of functional indicators of the temporomandibular joint, including range of motion.
* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed malocclusion or dentition insufficiency, confirmed by a dentist.

  * Presence of diseases of the musculoskeletal system, confirmed orthopedist or rheumatologist.
  * Acquired limb deformities (for example, flat feet, valgus or varus deformity).
  * Deforming dorsopathies (kyphosis, lordosis, scoliosis, osteochondrosis).
  * Consent to participate in the study and follow the treatment protocol.
  * Sufficient general physical and mental fitness to participate in the study

Exclusion Criteria:

* Systemic diseases affecting bone metabolism (eg osteoporosis).

  * Progressive neurological diseases.
  * Current treatment with steroids or immunosuppressive drugs.
  * Presence of malignant neoplasms.
  * Psychiatric disorders that prevent compliance protocol.
  * Pregnancy or lactation period.
  * Carrying out dental or orthopedic treatment in recent 6 months.
  * Skeletal malocclusions.
  * Diseases of the temporomandibular joint.
  * Congenital pathologies of the musculoskeletal system.
  * Arthropathy.
  * Systemic connective tissue diseases.
  * Biomechanical lesions of the musculoskeletal system.
Impact of Guidelines on Cardiovascular and Economic Outcomes With Focus on Lipid Lowering Drugs

Methods: All patients \<75 years registered in the Swedish Secondary Prevention after Heart Intensive care Admission registry (SEPHIA), will be followed-up within one year post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for recurrent cardiovascular disease (CVD) events and death will be used to estimate base case, and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´ Collaboration findings.

SWEDEHEART is a Swedish national registry consisting of several sub registries in which patients with acute coronary syndrome are prospectively registered. Patient characteristics, hospital treatments, drug treatments at discharge, and outcome for patients consecutively included and treated at all Swedish coronary care units are collected in this registry.SEPHIA is a sub registry collecting data on secondary prevention and cardiac rehabilitation. Follow-up are registered at six to ten weeks and at 12 to14 months post MI by office visits or phone. Around 80 % of all Swedish acute myocardial infarction (AMI) patients below the age of 75 years are included in this register.

In this study, a cohort of 5 904 (74% men) registered in the SEPHIA registry and who had one year follow-up during 2013, will be included. Data are aggregated and delivered from the SWEDEHEART/SEPHIA national registry. All patients were informed about their participation in the registry, the follow-up, and their right to decline participation. No written consent was obtained

Eligibility Criteria:
Inclusion Criteria: All patients with acute myocardial infarction registered in the SEPHIA registry and who had one year follow-up during 2013 -

Exclusion Criteria:none

-
Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).

More than 70% of patients with a proximal humerus fracture are older than 60 years, up to three quarters are women and the incidence of low-energy fractures increases exponentially with age. The standard diagnostic method for classifying osteoporosis is the measurement of Bone Mineral Density at specific body sites - hip, vertebra or distal radius. Despite the fact that osteoporotic fractures are very frequent at the shoulder, no study investigated the correlation between local bone quality and fracture treatment at the proximal humerus.

There is a concern among the clinicians that osteoporotic bone in proximal humerus fractures increases the risk of treatment complications. However, to our knowledge this has not yet been evaluated in clinical studies. One major reason for this lack of studies is the fact that no standardized method exists for the determination of bone density at the proximal humerus.

Eligibility Criteria:
Inclusion Criteria:

* Radiologically confirmed closed fracture (within 10 days) of the proximal humerus
* All dislocated (mod. Neer) proximal humerus fractures except dislocated fractures of the greater and lesser tuberosity
* Primary fracture treatment with a PHILOS-plate
* Age equal greater than 50 and equal younger than 90 years
* Normal function of both shoulders (pre-trauma) according to age
* Monotrauma
* Willing and able to give written informed consent to participate in the study
* Willing and able to participate in the study follow-ups according to the CIP
* Willing and able to comply with the postoperative management program
* Able to understand and read country national language

Exclusion Criteria:

* Open proximal humerus fractures
* Concomitant contralateral proximal humerus fracture
* Previous proximal humerus fracture on either side after the age of 25
* Time to operation \> 10 days
* Polytrauma
* Cuff-arthropathy of the contralateral proximal humerus
* Associated nerve or vessel injury
* Regular systemic therapy with corticosteroids due to chronic disease
* Legal incompetence
* Patient received radio- or chemotherapy prior to, during or within the last year
* Currently active cancer
* Recent history of substance abuse (i.e. recreational drugs, alcohol)
* Prisoner
* Currently involved in a pharmaceutical clinical study§
* Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)
* Simultaneous participation in another orthopedic/surgical study with the same or another fracture has to be approved by the AOCID.
Influence of Sarcopenia in Hepatocellular Carcinoma Patients

Liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. Locoregional therapies such as transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and radiation are associated with improved survival and quality of life for patients with unresectable HCC \[Couri and Pillai, 2019\]. However, curative therapies or locoregional therapies are not applicable to approximately 50% of HCC cases who are diagnosed at an advanced stage and have progression with transarterial therapies \[Park et al., 2015\]. For these patients, sorafenib, lenvatinib, and atezolizumab combined with bevacizumab have been approved as the first-line systemic therapy \[Fan et al., 2022\].

Sarcopenia is a progressive and generalized skeletal muscle disease characterized by accelerated loss of muscle mass and function \[Cruz-Jentoft and Sayer, 2019\]. It has been associated with higher mortality among the general population and patients with cancer. This study aims to assess the possible role of sarcopenia in predicting the outcome of HCC patients following a variety of treatments including local ablation, TACE and sorafenib.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of hepatocellular carcinoma.
2. Treatment-naive patients who underwent local ablation, TACE or sorafenib as a primary treatment .

Exclusion Criteria:

1. Use of other another HCC treatment modality e.g., resection.
2. Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.
3. Patients with recurrent HCC.
4. Patients with secondaries from extra-hepatic primary tumors.
5. Incomplete data at the diagnosis, treatment or follow up time-points.
6. Loss of patients follow up.
Prevalence of and Risk Factors of Obesity in School Children and Adolescents in Nag Hammadi City. 300 Participants.

Searching for obese children who's body mass index is above normal range and risk factors in children and adolescents in Nag Hammadi city


Eligibility Criteria:
Inclusion Criteria:

* children and adolescents 12to18years.

Exclusion Criteria:

* children younger than12 years and who have special conditions as deaf.
Deployment-Related Lung Disease Research Database and Biorepository

The purpose of this research study is to establish a research database and biorepository for patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF). This study will also include civilian contractors who worked as part of these military operations in Iraq or Afghanistan. The biorepository would store blood samples obtained from these patients during a clinic visit. The research database would store prospectively and retrospectively collected clinical and exposure data that would enable us to comprehensively characterize each case.

If informed consent is obtained, test results and other information collected for clinical reasons will be entered in a research database designed and maintained by DEOHS staff. The clinical data collected are part of the routine diagnosis and care of these patients. No additional procedures are required for the purpose of this research database. Collection of symptom and exposure data using a questionnaire designed for this study.

All NJH patients who served in southwest Asia will be approached for inclusion in the study. This will also attempt to contact patients evaluated previously at NJH for deployment-related lung disease to obtain informed consent to include data from their medical record and the research questionnaire in the database.

Eligibility Criteria:
Inclusion Criteria:

* Served in the southwest Asia wars

Exclusion Criteria:

* Did not served in the southwest Asia wars
Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects

This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specific procedures
2. Japanese healthy male subjects aged 20 to 45 years of age
3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
4. Clinically normal findings
5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

Exclusion Criteria:

1. Significant clinical illness
2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
3. Clinical significant condition which could modify the absorption of the investigational product
4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention