cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
* Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.
* Life expectancy of at least 12 weeks.
* Agreement to provide protocol-specific biopsy material.
* AEs from prior anti-cancer therapy resolved to Grade =\<1.
* Measurable disease.
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

* Inability to comply with protocol-mandated hospitalization and activities restrictions.
* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug.
* Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first forimtamig administration.
* Prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration.
* Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
* Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first forimtamig administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.
* Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
* Prior solid organ transplantation.
* Active auto-immune disease or flare within 6 months prior to start of study treatment
* Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.
DBT-SS for Cognitively Challenged Individuals With Deliberate Self-harm

The study evaluates the effect of Dialectic Behavior Therapy Skills System (DBT-SS) in individuals with Intelligence Quotient 65-85 and recurrent self-harm. The study is primarily descriptive with 6 cases followed by repeated measurements (weekly; time series analysis). Primary outcome measure is frequency and severity of self-harming behavior, reported weekly 4 weeks before the start of the intervention, throughout the intervention and 12 weeks after the intervention has stopped.

Not many psychotherapies are adapted to suit individuals with Intelligence Quotient(IQ) in the lower normal range. For individuals diagnosed with cognitive disability and self-harm, psychiatric treatment as usual often consists of only supportive meetings and sometimes heavy medication.

Dialectical Behavior therapy (DBT) is one of the evidence based treatments for individuals with self-harm and Borderline Personality Disorder. It is a comprehensive, multi component treatment, usually lasting a year or more. When offering DBT to individuals with cognitive disabilities or IQ in the lower normal range, it is necessary to alter the individual therapy procedures and skills group materials, while remaining adherent to DBT principles.

The Skills System is an adaptation of the standard DBT skills for individuals with cognitive challenges, well suited for IQ 65-85. When adapted DBT individual therapy integrates the Skills System as the skill group curriculum the treatment is called DBT-Skills System (DBT-SS). DBT-SS comprises weekly individual sessions, weekly group education and separate education for caregivers and/or near standing persons. The method is tested with positive effects on problem behaviors, however results need to be reproduced, and further tested in a randomized controlled trial. The handouts from Skills System has recently been translated to Swedish.

The current study aims to investigate the effect of Skills system on individuals with self-harm, IQ 65-85 and three or more symptoms of borderline personality disorder. A single-case time series design will be used with repeated, weekly measurements before, during and after the intervention is provided. 6 participants will be recruited in a pilot study, to investigate the feasibility of the method in a Swedish setting. Main outcome measures are frequency and severity of self-harming and aggressive behaviors, number of days with hospital admission and coercive care, number of medications, and self-rated level of daily functioning. Participation will last 64-70 weeks depending on when the group therapy starts in relation to enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Ongoing contact with adult psychiatric clinic
* Intelligence Quotient 65-85
* Current self-harming behaviour at least twice the last six months
* Staff from residential care or near standing persons are able to participate in the treatment by participating in group sessions.

Exclusion Criteria:

* Schizophrenia or Bipolar illness type 1
* Substance abuse
* Non-psychiatric disorder significantly contributing to symptoms.
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

PRIMARY OBJCETIVES:

I. Grade \>= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.

SECONDARY OBJECTIVES:

I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

OUTLINE:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed soft tissue sarcoma of the extremity/trunk
* Intermediate or high grade sarcoma
* Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
* Recurrent, any grade, no previous radiation therapy
* Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented

Exclusion Criteria:

* Active treatment of a separate malignancy
* History of prior irradiation to the area to be treated
* Pre-operative chemotherapy (post-op acceptable)
Turkish Life Balance Inventory

The Turkish Version of Life Balance Inventory: Validity, Reliability and Cultural Adaptation.

The Life Balance Inventory (Kathleen Matuska; 2012) is a measure for life balance. This study was planned for the purpose of carrying out Turkish Version of the Life Balance Inventory.

Eligibility Criteria:
Inclusion Criteria:

19-25 years old student at the Faculty of Health Sciences

-

Exclusion Criteria:

* not between age 19-25
Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)

The primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (CBT-I) compared to minimally enhanced usual care (mEUC) on primary outcomes: reduction in insomnia symptoms at 9 weeks and 6 months post-intervention, using a standard scale among Spanish-Speaking Latina/o adults with chronic insomnia.

Chronic insomnia is associated with significant public health burden and most adults seek care for insomnia in the primary care setting. While Latina/os are at greater risk for insomnia than non-Hispanic Whites, access to the recommended first-line of treatment, cognitive behavioral therapy for insomnia, is limited especially for Spanish-speakers. Recent advances in health information technology such as self-guided digital health treatments represent an innovative and scalable means to address the supply and demand imbalance that perpetuate mental health care disparities, however its implementation in underserved communities remains elusive. The purpose of this study is to compare the effectiveness of a culturally adapted digital version of Cognitive Behavioral Therapy for Insomnia with minimally enhanced usual care on reduction of insomnia symptoms among Spanish-speaking Latina/os adults with chronic insomnia. The study will also examine barriers and facilitators to implementation, and examine cost-effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia Severity Index Score for moderate insomnia symptoms (score\>10 on ISS)
* Spanish-speaking or bilingual (English and Spanish) and self-identify as Hispanic or Latina/o
* Report experience of sleep disturbances for at least 3x/week and for at least 3 months

Exclusion Criteria:

* Pregnancy
* Excessive sleepiness (score\>=16 on ESS)
* Caregivers of infants (\< 3 months) and/or of adults who require care at night
* Participants who are deemed unable to complete the study protocol due to dementia, severe cognitive impairment, severe medical or mental illness, or active substance use disorder
* Untreated moderate to severe obstructive sleep apnea or self-reported narcolepsy
* Unstable depression or insomnia medication regimen
* Patients who have full-time transportation/moving occupations
* Participation in another treatment/intervention study within the time period of initial baseline until the 6-month follow-up assessments
* Participation in regular night shift work, more than 1x/week, or non-standard sleep patterns
Assessment of CA 19-9 in Patients' With Thyroid Malignancies

Thyroid cancer is a rare disease that represents approximately 3.8% of all new cancer cases.Incidence of thyroid cancer in north Africa about 2.8% of all new cancer cases with mortality rate about 0.73%.Thyroid malignancies are classified into different groups as follows:Papillary thyroid cancer which is the most common form of thyroid cancer form about 80-90% of all thyroid cancers,Follicular thyroid cancer that forms about 10-15% of all thyroid cancers,Anaplastic thyroid cancer that forms less than 2% of all thyroid cancers,Medullary thyroid cancer that forms about 5-10% and other rare types include thyroid lymphoma, and thyroid sarcoma.

Medullary thyroid carcinoma (MTC) is a rare disease, and its classic tumor marker is calcitonin. However, recently, very aggressive cases have been reported to also secrete carbohydrate antigen 19-9 (CA19-9), and its role as a marker of worse prognosis has been questioned.

Thyroid cancer is a rare disease that represents approximately 3.8% of all new cancer cases.Incidence of thyroid cancer in north Africa about 2.8% of all new cancer cases with mortality rate about 0.73%.Thyroid malignancies are classified into different groups as follows:Papillary thyroid cancer which is the most common form of thyroid cancer form about 80-90% of all thyroid cancers,Follicular thyroid cancer that forms about 10-15% of all thyroid cancers,Anaplastic thyroid cancer that forms less than 2% of all thyroid cancers,Medullary thyroid cancer that forms about 5-10% and other rare types include thyroid lymphoma, and thyroid sarcoma.

Medullary thyroid carcinoma (MTC) is a rare disease, and its classic tumor marker is calcitonin. However, recently, very aggressive cases have been reported to also secrete carbohydrate antigen 19-9 (CA19-9), and its role as a marker of worse prognosis has been questioned.

CA19-9 was originally described as a gastrointestinal system and pancreas specific tumor marker. Immunohistochemical studies have demonstrated that CA19-9 is expressed in both differentiated and anaplastic thyroid carcinomas. Increased serum levels of CA 19-9 were reported in few patients with anaplastic thyroid cancer.The idea that CA19.9 could be predictive of mortality in MTC stems from early research which showed that serum creatinine and increased carcinoembryonic antigen levels were not important markers in MTC, but that Ca19.9, which is secreted in MTC, was significantly associated with progressive disease.

Eligibility Criteria:
* Inclusion Criteria: Patients with malignant thyroid tumors.
* Exclusion criteria: Patients with benign thyroid tumors ,Patients not known to have pancreatic disease.
Copmere Between Bleaching and Laminate Veneers

The present study is aimed to evaluation of shade for clinical color change of discolored teeth treated by bleaching vs laminate veneers.

Dental aesthetics, including tooth color, is of great importance for majority of the people and any discoloration or staining can affect their quality of life negatively1,2. In the UK it has been reported that 28% of grownups are dissatisfied with the appearance of their teeth and in the USA that 34% of grownups population are dissatisfied with their current tooth color. Moreover, in a survey of 3215 subjects from the UK 50% have admitted that they had some kind of tooth discoloration3,4.

Tooth bleaching has become one of the most popular aesthetic dental treatments. Because tooth bleaching is an effective, non-invasive procedure for the change of tooth discoloration, it is the best of treatment options for improving teeth color 5.

Ceramic restorations with excellent biocompatibility are widely used to achieve highly aesthetic characteristics in ﬁxed prosthodontics6. Porcelain laminate veneers have become a popular method of treated tooth discoloration. But are expensive, brittle and difficult to repair7.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in this clinical trial :

  * Men and women between 15and 40 years of age.
  * Had good general and oral health.
  * The participants needed to have six vital maxillary or mandibular anterior teeth without caries lesions or restorations.
  * The maxillary canine was shade A3 or darker as judged by comparison with a shade guide (VITA Classical Shade Guide or Spectrophotometer measurement ).

Exclusion Criteria:

* Participants were excluded from the study

  * If they presented with anterior restorations; had bruxism habits.
  * Were pregnant/lactating; presented with non vital tooth discoloration.
  * were taking any drug with anti-inflammatory, analgesic, or antioxidant effect; or presented with recession and dentin exposure
Study of CM310 in Adolescent Subjects With Atopic Dermatis

This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
* Subjects who must complete the evaluation of Week 18 of the main study.
* With Atopic Dermatitis.

Exclusion Criteria:

* Any major surgery planned during the research period.
* Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
* With any circumstance that the subject is not suitable to participate in this study.
Cuff Pressure in LMS

The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery.

It has been well known that cuff pressure should be adequately limited to prevent ischemic injury of tracheal mucosa, which is about 20-30 mmHg. However, higher cuff pressure that 20-30 mmHg might be required to prevent gas leakage during general anesthesia for laryngomicrosurgery.

The hypothesis of this study is that the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery, and there will be no damage from the required cuff pressure because of short time of surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule

Exclusion Criteria:

* Who doesn't agree to enroll
* do not use a reinforced tracheal tube of internal diameter of 5.5 mm for male patient
* do not use a reinforced tracheal tube of internal diameter of 5.0 mm for female patient
Manganese in Women With Encephalopathy

Objective:

Report manganese serum levels and mortality in encephalopathic patients.

Patients and participants:

Consecutive patients aged \> 18 years, with hepatic encephalopathy and informed consent signed by their families.

Interventions:

Patients' clinical characteristics as well as biochemical tests of renal function, hemoglobin, glucose and albumin levels were obtained as well as a blood sample to analyze manganese levels with a graphite furnace atomic absorption spectrometer.

Hypothesis:

There is a difference in the manganese levels between male and female patients.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged \> 18 years
* With hepatic encephalopathy
* Informed consent signed by their families

Exclusion Criteria:

* Portal bypass surgery
* Cancer of any localization
* Known malignancy and other severe diseases which shorten life expectancy \< 6 months
* Psychiatric illness
Grief and Communication Family Intervention

The overall purpose of this project is to evaluate the effects of a family therapy intervention for grieving families with children. The main outcome variable is family communication.

The intervention study will test a supportive family therapy intervention for families where a parent has died from cancer between 2013 and 2015. This will be a randomized controlled trial where participants are assigned to one of three groups using a random number sequence generated by a computer program with approximately 25 families in each intervention group.

Group one will meet with a family therapist for one 90 minute session where the main focus will be on providing information through psychoeducation on grief and communication to participants.

Group two will participate in a family therapy intervention comprised of three 90 minute sessions. participants will receive the same psychoeducation as group one and will also work with the family therapist to enhance family communication and process their grief. The 3 sessions are manual based.

Group three will be the control group and will not meet with a family therapist.

Participants will be asked if their sessions with the family therapist can be tape-recorded, but do not have to consent to this in order to participate. Approximately 6 participants need to be recorded in order to ensure that the family therapists are covering the same topics and giving the same information to all participants. In this way we can ensure that the method of intervention is the same no matter which therapist is delivering the intervention thereby validating the method of intervention.

Follow up will occur 1 month and 6 months after the intervention has ended. Each participant will fill in a short questionnaire regarding grief and Communication. Validated instruments will also be included in the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Participants are families with Children ages 3-19 who have completed our questionnaire study and have responses indicating that one or more family members have symptoms of complicated grief or a negative pattern of communication within the family. All family members who live in the same home may participate in the family therapy intervention including new partners or step children. It is up to the family to decide which family members will be included.

Exclusion Criteria:

* Participants must reside in Stockholm, Sweden during data collection, speak and understand written and spoken Swedish.
Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application.

Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.

Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.

547 patients who underwent CIED implantation from year 2016 - 2020 in our institute were enrolled. There were 438 Medtronic and 109 St. Jude's devices. All chest radiographs were de-identified and resized into 225\*225 pixels focusing on the CIED. PMIDa and CRMD-f applications were used to identify CIED. Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both applications were calculated and compared.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing CIED implantation and having xray post-implant at any point and time.

Exclusion Criteria:

* Patients with CIED for whome Xray was not available.
Validation of a New Standardized Clinical Anemia Evaluation Score Using a Hb Visual Scale in Nephrological Patients

The clinical evaluation of anemia is usually done by examination of the palpebral conjontivae coloration. This appreciation remains crude and largely observer dependent, as no reference scale was successfully proposed,. A Hb visual scale allowing the assessment of the degree of clinical anemia has been developed. Its use has been validated so far in small patient groups in the following settings: blood donation, cardiac surgery, oncology and consultation of general practitioners.

The objective of the present investigation is to validate the use of a Hb visual scale for the clinical evaluation of anemia in patients with kidney disease patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronich kidney disease