cyrilzakka/clinical-trials huggingface dataset:
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder

Eligibility Criteria:
Key Inclusion Criteria:

* Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood measured via the PCL-5 in combination with the LEC-5 at screening
* Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood as assessed by the CAPS, with a minimum score of 25 at baseline
* Able to identify a next of kin who is willing and able to be reached by the investigators in case of emergency
* Have successfully discontinued all prohibited medications at least two weeks prior to baseline visit. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of run-in will be required prior to baseline

Key Exclusion Criteria:

* Current or past history of schizophrenia, schizoaffective disorder or any other form of psychotic disorder, obsessive compulsive disorder, personality disorders, bipolar disorder, or any other significant disorder as assessed by clinician judgement and a structured clinical interview (MINI 7.0.2)
* Diagnosis of complex PTSD according to the International Trauma Questionnaire (ITQ)
* Borderline Personality Disorder as demonstrated by both the McLean Screening Instrument for Borderline Personality Disorder (MSI- BPD) score ≥ 7 and clinical confirmation of diagnosis by the study clinician and Medical Monitor
* Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during screening or at baseline, or; (2) suicidal behaviours within the past year, or; (3) history of serious suicide attempt that required a rescuing medical intervention, or; (4) clinical assessment of significant suicidal risk during participant interview
* Current (within the last year) alcohol or substance use disorder as informed by DSM-5 assessed via the MINI 7.0.2 at screening
* Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin
* Exposure to 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide (LSD), or peyote in the past year
* Primary diagnosis of major depressive disorder within 6 months of study entry
* Exposure to a traumatic experience in the past 3 months
* Significant childhood physical or sexual abuse based on clinician judgment with the use of CTQ
* Enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 21 days of baseline
Tissue Sample Study for Mitochondrial Disorders

The investigators are studying patients with undefined mitochondrial diseases to identify genetic mutations in nuclear or mitochondrial Deoxyribonucleic Acid (DNA). Most patients with suspected or known mitochondrial diseases have no genetic confirmation. The investigators expect that evaluating tissue samples from patients with mitochondrial disorders will lead us to discover mutations in new or known genes causing mitochondrial dysfunction.

Presently, the investigators know of about 200 mitochondrial disorders. The investigators know that there are about 1,300 genes responsible for mitochondrial function. Thus, there are a lot of mutated genes to be discovered out there. Currently, most patients with suspected or known mitochondrial disorders do not have genetic confirmation of the disease.

The goal of this project is to perform biochemical and DNA analysis on tissue samples of patients with mitochondrial disorders to find new genes that might be involved in mitochondrial dysfunction.

Leftover patient tissue samples will be obtained for analysis from within the Columbia Presbyterian Medical Center. Left over patient samples may also be sent from outside the institution. This is not a "first-step" in the diagnostic process, but rather an option for evaluation in patient samples for which no known diagnosis or genetic confirmation has been made.

The research laboratory does not guarantee that a sample will be analyzed. Sample analysis is performed according to research interest. If they choose, patients can be contacted should laboratory findings provide insight into their disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of having a mitochondrial disorder
* Patients who may carry a genetic mutation or be related to someone with a genetic mutation which may cause a mitochondrial disorder

Exclusion Criteria:

* Patients who are not suspected of having a mitochondrial disorder
Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer

There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer, with reports from observational studies and randomized controlled trials suggesting that:

1. The endometrium in stimulated cycles is not optimal for implantation
2. Pregnancy rates are increased following FET
3. Perinatal outcomes are less affected after FET
4. Preimplantation genetic screening We will follow only natural and modified natural cycles patients. Spontaneous ovulation will documented with hormonal and sonographic monitoring. Hormonal monitoring are including estradiol and luteinizing hormone (LH). Sonographic monitoring is including follicule diameter (16-20 mm). At modified natural cycles we will use hCG triggering for ovulation approximately 16-20 mm diameter.

We will compare success rate between natural and modified natural cycles

Eligibility Criteria:
Inclusion Criteria:

* Patient who are admitted to the IVF center and who will be transferred to frozen embryos.
* Infertile women under 40 years of age who accepted this study.
* Unexplained infertilite couple.
* All ovulatory patient.
* Male factor.
* Tubal factor.

Exclusion Criteria:

* Patients who made intrauterin surgery.
* Over 40 years of age women.
* Patients with preimplantation genetic diagnosis.
* Anovulatory patient.
Physical Capacity of Spina Bifida and Factors Affecting

Objective: It was aimed to evaluate the physical characteristics of the cases with spina bifida and to review the factors that may affect the etiology of the disease.

Methods: 48 cases with spina bifida and 48 control groups in other disease groups evaluated. A physiotherapist physically evaluated the cases after their personal information was obtained. A survey form examining the possible factors in the etiology of spina bifida was applied to the families.

The study was carried out with the participation of 48 cases with spina bifida between the ages of 0 and 2 evaluated in XXXXXX Training and Research Hospital (XXXXX) Pediatric Clinics and 48 control groups in other disease groups in response to each case.

The case group consisted of patients who were diagnosed in the Neonatal Intensive Care Unit between February 2019 and January 2020 (39 children), and who applied to the Physiotherapy and Rehabilitation Department from the centers outside for physiotherapy needs (9 children).

Eligibility Criteria:
Inclusion Criteria:

* spina bifida between the ages of 0 and 2

Exclusion Criteria:

* control group was formed through random selection among the children who were at the same age group between the same dates, did not have any diseases related to the neuromuscular system, and hospitalized for any other reason.
Does Provision of Point of Care CD4 Technology and Early Knowledge of CD4 Levels Affect Early Initiation and Retention on Anti-retroviral Treatment (ART) in HIV Positive Pregnant Women in the Context of Option B+ for PMTCT?

The study will be conducted at 32 health care facilities in three provinces in Zimbabwe and will compare the impact of the provision Point of Care CD4 technology and early knowledge of CD4 levels on retention at 12 months, with or without POC CD4 and a programmatic mentoring package. Option B+ will be implemented at all sites and 16 intervention sites will receive POC CD4 machines and visits from a team of clinical mentors.

The study also aims to assess rates of ART initiation and time to ART initiation of HIV positive pregnant women in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of retention in care of HIV positive mothers at 6 months post ART initiation in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of ART initiation and retention at 6 and 12 months post ART initiation according to different levels of CD4 count; cost of retaining HIV positive pregnant women until 6 and 12 months; acceptability and feasibility of POC CD4 as an adjunct to good clinical care of HIV positive pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant at the time of booking
* HIV positive diagnosis
* Not on ART at the time of booking
* Present up to 38 weeks into gestation
* Presents more than 48 hours prior to delivery

Exclusion Criteria:

* Already on ART at booking
* Presents more than 38 weeks into gestation or less than 48 hours prior to delivery
A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera

Jakavi® therapy for polycythemia vera (PV) has so far been studied exclusively in clinical trials and at selected clinical trial centres. This observational study is intended to document the therapy of PV in daily practice with a broad patient population and a geographically representative selection of German centres (both hospitals and practices). The prospective mapping of daily practice reality is thus the main goal of this project.

To achieve meaningful results in accordance with the study objective and to obtain long-term data from daily clinical practice in a real-world setting, the observation period under Jakavi® therapy is specified as 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients with PV for whom Jakavi® therapy is indicated according to the European summary of product characteristics
* Patients who have been informed about this NIS and gave written consent
Diabetes Peripheral Neuropathy and Small-fibre Nerve Damage: A Comparative Study

The purpose of this study is to investigate whether patients with diabetes-related peripheral neuropathic pain also have non-recognized damage to the intestine caused by autonomic neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic and as well as visceral sensory nerves. Classical autonomic parameters from electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course when patients develop gastroparesis, however an earlier recognition of this nerve damage may help clarifying the fundamental pathomechanisms and thereby optimize treatment for this patient group in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria (World Health Organization).
2. Proven peripheral neuropathy.
3. Oral and written consent, with documentation that all relevant information about the program is given to the patient.
4. The patient must be willing and able to, to meet the planned visit and meet the planned curriculum, including the participation in the experimental investigations.

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Medical or surgical disease for the study doctor's assessment makes the patient unsuitable for participation in the study
3. Previous or ongoing major depression
4. Patients who can or will not comply with the recommended instructions given by the study doctor
5. Use of analgesic opioid medication less than 24 hours before screening
6. Competitive conditions that can cause peripheral neuropathy (eg, herpes zooster)
7. Clinically significant disease less than 2 weeks from the planned entry in the study
8. People involved in the planning or execution of the study
Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills

Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room. Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed. Although an increasingly large number of patients are undergoing robotic hysterectomy and other robotic surgical procedures, little is known on how to ensure patient safety and treatment effectiveness when trainee surgeons participate in the operating room. Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery simulator by gynecologic surgical trainees on their intraoperative performance and on patient outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major academic medical center to either warm-up immediately before surgery on a robotic surgery simulator or to not warm-up. The attending surgeon supervising the trainee in the operating room is unaware of whether the trainee was assigned to warm-up or no warm-up. The investigators will compare standard robotic surgical skills assessments of the trainees by the supervising attending surgeons and patient outcomes in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the graduate (residency and fellowships) gynecology training program at the study institution;
* Participation as assistant surgeon in a robotic hysterectomy for benign indications for early stage uterine or cervical cancer.

Exclusion Criteria:

* Participation as assistant surgeon in a non-robotic hysterectomy or robotic hysterectomy for gynecologic cancer that has spread beyond the uterus based on preoperative imaging and biopsy.
Guerbet Liver Fibrosis

The goal of this study is to assess the value of liver dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and texture analysis post gadopiclenol for liver fibrosis staging, in comparison with MR elastography, T1 mapping, ultrasound elastography and blood tests in 50 initial patients with metabolic dysfunction-associated steatohepatitis (MASH).

Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as nonalcoholic fatty liver disease or NAFLD) is characterized by the accumulation of excess fat in the liver, ranging from mild forms like non-alcoholic fatty liver (NAFL) to more severe stages such as metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) with associated inflammation, ballooning, fibrosis, and cirrhosis. The severity of MASH and increasing fibrosis stages is associated with higher morbidity and mortality rates. The study will compare dynamic contrast-enhanced (DCE)-MRI measurements of perfusion using gadopiclenol for diagnosis of liver fibrosis to MR elastography and transient elastography, T1 mapping, ultrasound elastography and blood tests, using histopathology as the reference in patients with MASH. In this study, the value of DCE-MRI and texture analysis using gadopiclenol, a new macrocyclic, non-ionic, extracellular contrast agent with high relaxivity will also be assessed which provides, at a lower dose, better contrast-to-noise ratio than gadoterate, gadobenate, and gadobutrol.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected MASLD (F0-F4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of MRI (before or after MRI).
* Both genders.
* Age \> 18 years.
* Any racial/ethnic background.

Exclusion criteria:

* Previous history or current diagnosis of HCC or decompensation.
* Contraindications for MRI, including

  * Medically unstable
  * Intracranial clips
  * Metal implants
  * Suspected or confirmed metal in eyes
  * Cardiac pacemaker, implanted defibrillator, other implanted electronic device
  * Pregnancy: Pregnancy tests will be offered to women of childbearing age at no cost
  * Severe claustrophobia
Examination of the Time Advantage Between POCT and Conventional Central Laboratory Analysis

The aim of the present study is to quantify the time advantage achieved by the use of POCT compared to conventional coagulation diagnostics. A further objective of this study is an analysis of the result quality of POCT for the prothrombin time / international normalized ratio.

In order to be able to carry out a targeted coagulation therapy for the time-critical treatment of coagulopathic emergency patients, knowledge of the hemostatic potential is necessary.

After taking blood samples for coagulation diagnostics, they are sent to the central laboratory. After the analysis and validation the electronic provision of the results takes place. The loss of time by sample transport, analysis and breadth of the results extends the duration until therapy can be started.

The period of time until these analysis results are determined depends on several factors like daytime, day of week and location of the sample consignor and the availability of the laboratory. Not every clinic is connected to an internal tube mail system so that the samples have to be sent partly with a transport service.

In recent years, Point of Care (POCT) devices have become an increasingly important tool for diagnosing coagulopathic patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Missing written consent
* Withdrawal
Acceptability Study on Nutricomp® Drink Plus Fibre in Adults

Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to show that it is acceptable for patients in the United Kingdom.


Eligibility Criteria:
Inclusion criteria:

* Male and female participants ≥ 18 years of age
* Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
* Anticipated period of nutritional support ≥ 12 days
* Patient has the capacity and is willing to provide informed consent.

Exclusion criteria:

* Participants with mental in capabilities who are unable to give informed consent
* Hypersensitivity to any of the active substances or excipients within the IP
* Severely impaired gastrointestinal function or complete failure
* More than 50% of nutrition from Parenteral Nutrition
* Simultaneous participation in another interventional study
* Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
* Participants with dysphagia requiring thickened fluids
* Participants with significant renal impairment (CKD)
* Pregnancy
Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

SARS-CoV-2 infection is a condition characterized by excessive leukocyte infiltration, massive release of chemokines, proteases and cytokines, the so-called "cytokine storm", which promote the inflammatory process and contribute to exacerbation of COVID-19 symptomatology. Because of the abnormal release of pro-inflammatory cytokines by non-neuronal cells of the immune system, such as the mast cells in periphery, and microglia at central level, the body activates a defensive neuroinflammatory process that, if not controlled, can become pathological. Therefore it's important to intervene early on neuroinflammation, in order to limit the progression of the disease.

A possible intervention is represented by Palmitoylethanolamide (PEA), an endogenous molecule of the N-acylethanolamine family synthesized "on demand" in response to "stress factors" to restore tissue homeostasis, able to control mast cells and microglia uncontrolled activation. Experimental evidence in vitro and in vivo demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultra-micronized PEA (mPEA and umPEA), confirmed in various clinical investigations conducted in patients with different pathological conditions. The aim of this study is to investigate the efficacy of a compound containing mPEA + umPEA on peripheral inflammatory markers, neuroinflammation, and others clinical parameters in intensive care patients with COVID-19 interstitial pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Intensive Care Unit Hospitalization for interstitial pneumonia due to COVID-19 diagnosis (nasal swab/sputum/bronchoalveolar lavage positive for Sars-Cov-2 infection)

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Known allergy or hypersensitivity to the product or its excipients;
* Inability to take the product per os or via nasogastric tube.
Art Therapy Intervention for Breast Cancer Patients

As studies continue to debate the effects of quality of life on survival, increased attention is being focused on investigating complementary alternative therapies to boost overall total health in cancer patients . Art therapy is an interesting growing field, which has shown promise to positively influence quality of life in the pediatric and adult oncology population alike. As there is a paucity of well controlled complete studies in this field, the investigators propose to study the impact of art therapy sessions in women with breast cancer with quantitative and qualitative analysis of emotional health and physical symptoms.

The results of the investigators study will have widespread applicability to oncology programs that wish to offer/implement such sessions to their palliative and non-palliative outpatients in an effort to address the important concept of whole person care.


Eligibility Criteria:
Inclusion Criteria:

1. Any woman 18-years or older
2. Stage I to III breast cancer (first time diagnosis)
3. Minimum of 6 weeks Post Operative status
Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures

A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.


Eligibility Criteria:
Inclusion Criteria:

* All medically stable twin infants admitted to the NICU who are:

  1. Free from infection; and
  2. Breathing room air or receiving oxygen via nasal prongs.
* Twins may be receiving feeds via gavage tubes, IV therapy via peripheral or central line, and may be experiencing periods of apnea.

Exclusion Criteria:

* Weigh less than 1000 grams;
* Receiving ventilator support;
* Have chest tubes or umbilical catheter in situ;
* Have major congenital anomalies or chromosomal aberrations; OR
* If only one of the twins require overhead phototherapy.