cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder

To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD).


Eligibility Criteria:
Not available at time of registration
Research of Serum Procalcitonin, ESR, CRP And Leukocyte Levels in Fertile Missed Abortion Cases

Aim: The serum procalcitonin, erythrocyte sedimentation rate, c-reactive protein and leukocyte values will be compared between fertile missed abortion diagnosed pregnants and fertile normal pregnants to determine the presence of subclinical infection in the etiology of missed abortion

The study group will consist of 30 fertile, under 35 years old women having for the first time missed abortus diagnosis in the Obstetrics Department of Obstetrics and Gynecology of Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine. As control group, 30 cases with the same trimester, fertile, and under 35 years old who had referred to Obstetrics clinic, who had no systemic disease, will be included in the study. Blood samples will be collected at the time of diagnosis of the patients with missed abortion and in normal pregnancy in the week of 20th gestational week and will send to Biochemistry laboratory to examine procalcitonin, erythrocyte sedimentation rate, c-reactive protein and leukocyte values in their sera. The age, weight, gestational week, gravida (number), parity (number), abortus (number), body mass index, systemic diseases, blood group, smoking information, binary test results, and results of genetic analysis will be collected in both groups. The pathology results of the missed abortion group will also be collected. The results will statistically be compared in the SPSS 13.0 program in both groups.

Eligibility Criteria:
Inclusion Criteria:

* fertile, less than 20 weeks of geese who have missed abortus for the first time without systemic disease

Exclusion Criteria:

* Failure to meet the missed abortus diagnostic criteria (for the group of fertile missed abortus)
* Smoking
* Rejection to participate in the study.
Comparing Postoperative Pain Following COX-2 and Prostanoids Expression

The purpose of this study is to compare postoperative pain following COX-2 and prostanoids expression in women who underwent laparoscopic surgery for female genital disease in order to evaluate the effect of COX-2 on local inflammation, COX-2 and prostanoids expression followed by exposure time to carbon dioxide(CO2) gas, and degree of postoperative pain.

In women who underwent laparoscopic surgery for female genital disease, the effect of COX-2 on local inflammation was assessed by randomization, using the COX-2 inhibitor celecoxib and placebo, comparative evaluation of expression of COX-2 and prostanoids by pre/postoperative peritoneal biopsy and postoperative pain depending on gas exposure time

Eligibility Criteria:
Inclusion Criteria:

* Female, Age ≥ 20 years
* Patients with benign female genital disease who need laparoscopic surgery
* Patients with benign disease who can be treated by single port laparoscopy
* Patients who signed an approved informed consent

Exclusion Criteria:

* Female, Age \< 20 years
* Pregnancy
* Previous cancer history
* Patients who refuse to sign an informed consent
* Patients with benign female genital disease combined clinical peritonitis (ex. tubo-ovarian abscess, tubo-ovaritis, ruptured endometriosis)
* Patients with malignant female genital disease
* Patients who got surgery with multi-port laparoscopy
* Patients who are contraindicated with COX-2 inhibitors (liver disease, renal disease, active peptic ulcer, active gastrointestinal tract bleeding, ischemic heart disease, hyperkalemia)
Impact of Literacy Level on Patient Education and Health Among People With Arthritis

People with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. Patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. The purpose of this study is to compare the health outcomes of patients with arthritis given either standard 11th grade level materials or interactive, in-person arthritis education along with materials written at a lower reading level.

Patients with poor literacy report worse health and know less about managing their disease than patients with better literacy. This study will compare the disease outcomes of arthritis patients at three different reading levels who receive either standard arthritis materials written at an 11th grade reading level or an in-person, interactive, text-free session along with lower reading level materials. The study will determine the most effective methods of educating patients with poor literacy about their disease.

Patients with systemic inflammatory rheumatic conditions (rheumatoid arthritis, psoriatic arthritis, and seronegative polyarthritis) will be assessed and placed into one of three reading levels: 8th grade or lower; 9th to 11th grade; or 12th grade or higher. Patients from each reading level will be randomly assigned to one of two intervention groups. Group 1 will receive disease-specific material from the Arthritis Foundation written at an 11th grade reading level. Group 2 will receive plain language materials, an arthritis glossary, and a one-hour, in-person session with a study educator using interactive, text-free methods. The study educator will help the patient with reading-related problems either by study visit or by telephone for 6 months postsession.

All patients will receive a medication calendar. Patients will be followed for one year after the intervention and will be assessed for changes in health status, disease activity, communication with the physician, self-management of their arthritis, understanding of and adherence to prescribed treatment, and satisfaction with their intervention.

Eligibility Criteria:
Inclusion Criteria:

* Native English speaker
* Patient at the Rheumatology Clinic at Brigham and Women's Hospital, Boston, Massachusetts
* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis
Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression

The investigators are doing this research study to find out if the Stress Management and Resiliency Training (SMART) therapy will help subjects with their major depression treatment.

The investigators propose to conduct an initial feasibility study in a sample of patients in treatment for major depression using SMART. The intervention will be weekly group therapy session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of 6-8 research participants per group. There will be no comparison group. The investigators aim to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the homework assignments. Resilience will be measured with the Connor-Davidson resilience scale. Secondary outcomes will include subjective and objective clinical rating scales for major depression.

Eligibility Criteria:
Inclusion Criteria:

* Attending the Mayo Clinic Depression Center and Behavioral Health Clinic at Mayo Clinic Health System, Austin, Minnesota
* DSM-V diagnostic confirmation of major depressive disorder (MDD)
* Baseline PHQ-9 scores in the range of ≥6-≤19, and HAMD-17 score 8-18, or QIDS-C16 score of 6-20
* Able to speak English
* Participants will continue taking any prescribed medications from their clinical treatment team
* Patients with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.

Exclusion Criteria:

* Participants with bipolar disorder
* Active psychosis
* Active suicidal ideations
* Active substance abuse meeting criteria for substance use disorders except nicotine
* Obsessive compulsive disorder
* Active Panic disorder with agoraphobia, other phobic disorder
* Active Posttraumatic stress disorder
* Active Severe personality disorders.
Smoking Cessation Behavioral Treatment Study

The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and up
* English fluency as demonstrated in providing informed consent and the ability to independently follow directions in completing assigned assessments and tasks
* Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
* Current nicotine dependent smoker with a minimum smoking history of 2 years
* Interest in quitting smoking

Exclusion Criteria:

* Use of psychotropic (e.g. antiepileptic) medications in the past month
* Positive urine drug screen
* Presence of an untreated medical illness
* Current or past psychosis
* History of major neurological illness or head injury resulting in loss of consciousness
* And contraindication to MRI, including claustrophobia
* Among females, positive urine pregnancy test
* Inability or unwillingness of subject to give informed consent
The Effect of Acute Mild Dehydration on Blood Pressure Control

The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition.

The purpose of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. Additionally, we will determine whether or not the sympathetic nervous system has a role in mediating blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition. This will allow for a within participant comparison. Additionally, we will later determine if age alters blood pressure control at rest or during static exercise.

Eligibility Criteria:
Inclusion Criteria (Young):

• age: 20-35 years old

Exclusion Criteria (Young):

* high blood pressure (\>140/90 mmHg)
* history of cardiovascular disease
* history of cancer
* history of diabetes
* history of kidney disease
* obesity (BMI \> 30 kg/m2)
* smoking or tobacco use
* current pregnancy
* nursing mothers
* communication barriers

Inclusion Criteria (Older):

* age: 60-75 years old
* ECG within normal limits
* screening blood panel within normal limits

Exclusion Criteria (Older):

* high blood pressure (\>140/90 mmHg)
* history of cardiovascular disease
* history of cancer
* history of diabetes
* history of kidney disease
* obesity (BMI \> 30 kg/m2)
* smoking or tobacco use
* current pregnancy
* nursing mothers
* communication barriers
A Study of Gastric Delay in Migraine Patients (3207-003)

A study to assess safety and PK of an investigational drug in migraine patients during and between migraine attacks.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking male or female between 18 to 45 years of age
* Patient typically has between 2 and 10 migraine attacks per month, rated as moderate or severe

Exclusion Criteria:

* Patient has any other medical conditions other than migraine
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.


Eligibility Criteria:
Inclusion Criteria:

* Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
* Is scheduled to undergo a unilateral Total Shoulder Arthroplasty (TSA) or abdominoplasty.

Exclusion Criteria:

* Is undergoing a revision surgery.
* Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
* History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
* Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
* Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
* Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery.
* Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer).
* Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years.
* Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy).
* Has a body mass index (BMI) \>40 kg/m2.
* Had undergone prior abdominoplasty or major abdominal wall surgery.
Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9

The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.

To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pediatric/adolescent solid tumor (including neuroblastoma, rhabdomyosarcoma, Ewing's/PNET, osteosarcoma, brain tumors, desmoplastic small round cell tumor (DSRT) and other tumors that are 8H9-positive) confirmed by the MSKCC Department of Pathology.
* Patient must have either recurrent disease or have \<20% chance of long term disease-free survival.
* Patient must be at least 1 year old. Age can range from 1-50 years of age.
* Patients should have measurable or evaluable disease. For tumor types that are known to be 8H9-positive, patients can be imaged after the diagnosis is made, prior to definitive surgery or surgery to confirm tumor recurrence.
* Tumor tissue is or will be available for 8H9 immunostaining. For patients with tumor-types known to be 8H9-positive, surgical samples obtained after 131I- 8H9 imaging will be immunostained to confirm 8H9-reactivity. These tumor types include: neuroblastoma, rhabdomyosarcoma, osteosarcoma, DSRT, Ewing's Sarcoma/PNET), brain tumors (glioblastoma multiforme, mixed glioma, astrocytoma, ependymoma, medulloblastoma, schwannoma., meningioma).
* If frozen tumor tissue is unavailable, and if bone marrow involvement is demonstrated by histology, 8H9 immunostaining by immunofluorescence will be carried out on patient's bone marrow. In this case, patients will be eligible for study if bone marrow 8H9 immunostaining is positive.

Exclusion Criteria:

* Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal, and neurologic system toxicity should all be less than grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with \<= 3 hearing loss are not excluded.
* Clinically apparent infections.
* History of allergy to iodine or mouse proteins.
* Patients previously treated with mouse monoclonal antibodies are not eligible unless they have no circulating HAMA.
* Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
* Patient's own tumor is negative by 8H9 immunostaining.
Transcriptomic Analysis to Put an End to Misdiagnosis in Patients With Rare Muscle Diseases

Since 2017, more than 250 analyses performed at the Molecular Genetics Laboratory of the Timone Enfant Hospital have yielded negative results in patients with rare genetic muscle diseases. The researchers hypothesise that some of these misdiagnosed patients carry pathogenic RNA (transcript) disrupting variants that were not identified by DNA sequencing. In fact, DNA sequencing analyses can be negative despite the presence of a pathogenic variant that disrupts RNA splicing or expression, causing a genetic disease. For this reason, RNA sequencing can provide a diagnosis in patients who have not been diagnosed by DNA sequencing, thus putting an end to diagnostic wandering. Thus, as a descriptive prevalence study, the objectives are first to determine the rate of positive diagnoses made by the RNAseq approach in patients with muscle diseases that have not yet been diagnosed, and then to identify the genomic characteristics of the pathogenic variants identified in patients by RNAseq analysis, in order to facilitate the identification of this type of variant in future patients.

50 patients will be included in this study during 2 years.


Eligibility Criteria:
Inclusion Criteria:

* patients with rare genetic muscle diseases who have benefited from high-throughput sequencing analysis (panel of 200 genes defined by the FILNEMUS Rare Neuromuscular Disease Network) carried out at the Molecular Genetics Laboratory, Medical Genetics Department, Timone Enfant Hospital since 2017.

This criterion is necessary to limit the analysis to patients with muscular diseases among all the patients analysed by the Molecular Genetics Laboratory.

* this genetic analysis did not identify pathogenic variants explaining the patient's phenotype This criterion is necessary in order to include only patients in diagnostic error.
* a muscle biopsy of the patient is available in the Biological Resources Centre (CRB) at the AP-HM.

Exclusion Criteria:

* Patients with no muscle biopsy available in the CRB.
* Patients with an established molecular diagnosis.
* Patients for whom RNA extraction from a muscle biopsy sample did not yield RNA of sufficient quality (INR \>7) will be excluded from the study. A maximum of two extraction attempts will be performed.
A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation

The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.

This is a non-interventional, prospective and retrospective study of participants with cHL and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in real-life clinical practice.

The study will enroll approximately 2000 participants. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:

* Newly Diagnosed and RR cHL Participants
* Newly Diagnosed and RR sALCL Participants

This multi-center trial will be conducted in Russia. The retrospective data will be collected for the participants with RR cHL or RR sALCL at the time of enrollment and for participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline). The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants 18 years or older by the time of enrollment.
2. Histologically confirmed diagnosis of cHL or sALCL.
3. Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion in the Study.

Exclusion Criteria:

1. Unconfirmed diagnosis of cHL or sALCL.
2. Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
3. Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).
4. Participants for whom the minimum study dataset was not available from their hospital medical records.