cyrilzakka/clinical-trials huggingface dataset:
DBT Skills Plus EMDR for BPD and Trauma

Borderline Personality Disorder (BPD) is a severe disorder that frequently co-occurs with post-traumatic stress disorder (PTSD). The comorbidity of BPD and PTSD is more disabling, predicting lower rates of BPD remission. Dialectical behavioral skills training (DBT-ST), is a group-delivered training that covers four types of skills: emotion regulation, mindfulness, interpersonal effectiveness and distress tolerance. As a stand-alone treatment, research suggest that DBT-ST is an efficacious treatment for BPD. In parallel, EMDR has emerged in last years as an efficacious approach to adult trauma. However, so far, the efficacy of EMDR to treat trauma in populations with BPD diagnosis has not been tested. The present pilot randomized-controlled clinical trial aims to test whether a combination of DBT-ST plus EMDR could be efficacious to treat trauma in individuals with BPD. 40 participants will be recruited from the BPD Unit at the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain) and will be randomized (1:1) to DBT-ST + EMDR or DBT-ST alone. The primary outcome will be the reduction of PTSD symptoms. In addition, symptom-related variables will be collected before and after the interventions. This will be the first study to test the combination of DBT-ST and EMDR.


Eligibility Criteria:
Inclusion Criteria:

* men and women between 18 and 60 years old
* having had adverse childhood experiences and/or current PTSD symptoms
* signed informed consent

Exclusion Criteria:

* lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder, or mental retardation.
* participation in any psychotherapy during the study or having received DBT or EMDR in the past
Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.


Eligibility Criteria:
Inclusion Criteria:

* presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound
* able to provide informed consent and comply with study protocol
* English or Spanish-speaking
* candidate for outpatient cervical preparation

Exclusion Criteria:

* Anyone with an allergy to misoprostol, mifepristone or any study medication
* premature rupture of membranes
* intrauterine fetal demise
* placenta previa
* suspected abnormal placentation
* evidence of infection at the time of enrollment
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors

This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 16 years
* Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP)
* Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria:

  * Testicular primary site
  * Prior treatment limited to one program (or 6 or fewer cycles of cisplatin)
  * Either a complete response or a partial response with normal serum AFP and HCG
* Relapse documented by rising AFP and/or HCG or by a biopsy
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min
* Absolute granulocyte count \>= 1,500/mm3, platelets \>= 100,000 mm3, bilirubin \< 1.5 fold the upper normal value
* Signed informed consent.

Exclusion Criteria:

* Patients infected by the human immunodeficiency virus (HIV)
* Patients who do not fit inclusion criteria
Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors

This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.

PRIMARY OBJECTIVES:

I. To determine the effect of a 12-week behavior/exercise intervention on moderate-vigorous physical activity (\> 150 minutes) among ethnically diverse endometrial cancer survivors.

SECONDARY OBJECTIVES:

I. To determine the effects of a 12-week behavior/exercise intervention on body composition among ethnically diverse endometrial cancer survivors.

TERTIARY OBJECTIVES:

I. To determine the effects of a 12-week behavior/exercise intervention for ethnically diverse endometrial cancer survivors on physical function and quality-of-life.

II. To determine the most important behavioral variables for predicting physical activity adherence.

III. To determine the most significant facilitators and barriers to adherence during the 12-week intervention.

IV. To compare the thematic differences between high-adherence and low-adherence participants and qualitatively assess the strengths and weaknesses of the 12-week intervention.

OUTLINE: Participants are randomized to 1 of 2 groups

GROUP I: Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks.

GROUP II: Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I.

After completion of study, participants are followed up at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent form signed and dated by the subject
* English and/or Spanish speaking
* History of endometrial cancer stage I-IV \> 6 months \< 5 years, not currently receiving cancer treatment
* Overweight (body mass index \[BMI\] \>= 30)
* Eastern Cooperative Oncology Group performance status (PS) of 0 - 2
* Medically capable of performing moderate intensity exercise

Exclusion Criteria:

* Must not have engaged in a regular (\> 3x/week, physical activity program in the last 6 months)
* Medical contraindication to exercise
Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD)

Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.

Complications due to the medical practice are the third cause of morbidity(BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.

Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.

The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using a Connected Medical Device (CMD).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients receiving a non-ambulatory surgical or interventional procedure lasting more than 2 hours
* Affiliation with a social security syste, beneficiarie or eligible people (excluding State Medical Assistance (AME))
* Written consent of the patient

Exclusion Criteria:

* Patient carrying a multi-resistant germ and placed in isolation
* Patient's known linguistic inability to understand the study
* Non-ambulatory surgical or interventional act in an emergency situation
* Patients under legal protection : curatorship or guardianship
* Known pregnancy or nursing woman
* Patients with implantable cardiac pacemakers, implantable defibrillators or neurostimulators
Electromyographic Assessment of the Shoulder Stabilizing Musculature in CrossFit® Athletes

This is an observational analytical study of prevalent cases and controls.

Approximately 39 subjects who practice CrossFit at least 6 hours a week are invitated to participate in this observational study. It will measure the activation of trapezius and Serratus muscles by Electromyography experiencing a feeling of fatigue 7-8 in PushPress and PullUps.

Eligibility Criteria:
Inclusion Criteria:

* Practicing CrossFit® for at least 1 year
* A minimum of 6 hours per week CrossFit® training
* No shoulder pain at the time of measurement

Exclusion Criteria:

* Tendinitis
* Bursitis
* Sistematic disease
* Nurological disease
* Central or periferic disease
Needs Assessment Tool Integrated in Clinical Practice of Head and Neck Cancer Rehabilitation

The study tests a needs assessment and decision-making tool with patients who are in need of rehabilitation after surgery for Head and Neck Cancer. The purpose is to enhance patient involvement in decision-making.

The study tests a needs assessment and decision-making tool with patients surgically treated for Head and Neck Cancer. The tool will be an integrated part of a new clinical practice with nursing consultations at three seperate time-points in the post-surgical period of the patients. Half of the participants will receive nursing consultations using the tool and the other half will receive standard care.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Head and Neck Cancer
* Stage T3 or T4
* Surgically treated
* Must be able to speak and understand Danish

Exclusion Criteria:

* Treated surgically for thyroid or parotic cancers
* Referred to adjuvant radio - or chemotherapy
* Having an unstable psychiatric illness.
Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques

The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease.
* Subjects must be able to self-consent.
* Department of Defense beneficiary

Exclusion Criteria:

* Patients will be excluded if they undergo a concurrent procedure for prolapse.
* If the indication for the procedure is a malignancy.
* Those that plan to leave the area in less than 1 year will not be included.
* Pop-Q Point C of \>-4
The UK CAVIAR Study

CAVIAR is a multicentre prospective observational study. Centres for cardiac and vascular surgery assess and manage patients in different ways before surgery. Some centres have introduced the use of intravenous iron therapy for patients with anaemia in the preoperative setting. Consequently regional variation exists in the assessment and management of patients before cardiac and vascular surgery. We aim to observe and measure these differing pathways and observe if there is variation in iron deficiency and anaemia and the impact of these variables on patient cardiorespiratory function as well as post-operative outcomes.

\[Sub-Study\] For patients who are receiving intravenous iron therapy as part of their routine clinical care, we wish to observe this effect in more detail. We will assess the impact of the treatment on well-being, blood count and fitness. Information will be collected through Quality of Life questionnaires, total haemoglobin mass test (via blood collection) and fitness testing.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 18 years or older
2. Screening \[Hb\] \< 120 g/L (for females) or \< 130g/L (for males)
3. Undergoing elective cardiac OR vascular surgery:

   * Coronary artery bypass (CABG), or valvular surgery, or combined CABG and valve surgery.
   * Repair or replacement of thoracic or abdominal aorta (open or endovascular).
4. Able to provide informed consent
5. (if applicable) Able to perform CPET or 6MWT if consented to take part in the sub study

Exclusion Criteria:

1. Pregnancy or lactation
2. Adults with known underlying history of learning disabilities, or adults who do not have mental capacity to consent for themselves
3. Prisoners
4. Renal dialysis (current or planned within the next 12 months)
Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Lumbar Radiculopathy.

The purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine.

IONM is the use of real time neurophysiological techniques during spinal surgeries. The modalities included in this study are:

* Somatosensory evoked potentials (SSEPs).
* Trans-cranial electric motor evoked potentials (tceMEPs).
* Spontaneous electromyography (EMG).

Clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales:

* Oswestry Disability Index 2.1a
* Visual Analogue Scale for Pain
* Patient's Overall Impression of Change

Radiculopathy associated to lumbar disk disease is one of the most common reasons for a spine surgeon to be consulted. The pathophysiology of degenerative spine disease is acknowledged as complex, involving a wide array of risk factors ranging from genetic polymorphisms, to behavioural characteristics. While conflicting opinions exist with regard the direction of treatment for lumbar disk disease, de-compressive surgery is currently the gold standard for patients in which protocols of physiotherapy and analgesics have failed to comply.

Intraoperative neurophysiological monitoring (IONM) is widely used in the practice of spine surgery as a mean of preventing and reducing severe complications inherent to surgical techniques like paraparesis, paraplegia and quadriplegia. Indeed, a great deal of funding and work have been devoted to research projects seeking to determine the impact of IONM in reducing these risks. The results of such projects have been notoriously interesting, and frequently opposing to each other. This has lead to an open debate on weather the use of IONM may or not be justified by better outcomes in patients who undergo such procedure. To our knowledge there is no study in the literature that has addressed the potential role of the IOM to predict the long-term outcome of the patient in therms of radicular symptoms improvement.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Lumbar Disk Disease
* Clinical Signs of Radiculopathy
* Undergoing neurological surgery of the spine

Exclusion Criteria:

* Previous neurological surgery of the lumbar spine
* More than 2 levels intervened at the surgery
* Serious post-operatory complications
Study to Assess Safety and Efficacy of DF01 in Reducing Prolonged Labor

The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time to delivery will be measured from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes.


Eligibility Criteria:
Inclusion Criteria:

* healthy nulliparous females
* normal singleton pregnancy
* intact membranes

Exclusion Criteria:

* breech or other abnormal presentation
* intercurrent illness
* pregnancy complications
* vaginal bleeding in third trimester
* etc
Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults

Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers.

Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.

Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group.


Eligibility Criteria:
Inclusion Criteria:

* Not be engaged in any regular and systematic strength and aerobic training with a frequency greater than one session per week in the previous six months;
* To live in Pelotas without the intention of moving or traveling during the intervention period.

Exclusion Criteria:

* Language and cognition problems (accessed through the Mini-Mental State Examination, minimum score ≥28 points for people with \>11 years of schooling, ≥23 points for people with 1-11 years of schooling, and ≥16 points for illiterate);
* History of cardiovascular diseases (except medication-controlled hypertension);
* Osteoarticular limitations that may impair physical exercise performance, such as fracture, prosthesis placement, or severe injury in the last six months.
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.


Eligibility Criteria:
Inclusion Criteria:

1. Age 10-16 completed months (age corrected for prematurity) at baseline
2. Discontinued regular breastfeeding and formula feeding at the time of randomization
3. Gestational age \< 35 completed weeks at birth
4. English is primary language in home
5. Informed consent obtained and signed
6. Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance

Exclusion Criteria:

1. Feeding problems
2. Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
3. Weight \< 5th or \> 95th percentile for age, per WHO growth charts
4. Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
5. Plans to move out of the area within the next 6 months
6. Known corn allergy
7. Known soy allergy
8. Known fish allergy
Prostin and Propess in Induction of Labor

The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).

A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 37 weeks or more
* Singleton pregnancy
* Cephalic presentation.

Exclusion Criteria:

* Previous cesarean section
* Any contraindication for vaginal delivery
* Suspected Cephalo-Pelvic Disproportion
* Unexplained antepartum Hemorrhage
ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans

This study investigates access, effectiveness, and acceptability of 1-day ACT workshops on problematic mental health symptoms.

This study proposes to investigate access, effectiveness, and acceptability of 1-day ACT workshops delivered in 2 rural VA primary clinics with 32 Veterans with problematic mental health symptoms (i.e., depression, PTSD, or anxiety) that are risk factors for suicide.

Eligibility Criteria:
Inclusion Criteria:

* 1) current mental health symptoms as measured by one of the following indicators: PHQ-9 ≥ 10, PCL-5 ≥ 30, or GAD-7 ≥ 10.

Exclusion Criteria:

1. cognitive impairment measured by BOMC,
2. current psychosis or mania as evidenced in the medical record,
3. current suicidal intent as measured by the P4,
4. use of mental health services within or outside of VA in the last 6 months as measured by CPRS and the non-VA services questionnaire.