cyrilzakka/clinical-trials huggingface dataset:
From Inflammation to Remodelling Towards Personalized Diagnosis in Post-acute Sequelae of COVID-19

Rationale: The diagnosis and pathogenesis of long COVID remains unknown. We have previously shown that \[68Ga\]FAPI Positron Emission Tomography-Computed Tomography (PET/CT) imaging shows potential for diagnosis and molecular understanding of this syndrome. We have previously shown that fibroblast activation protein (FAP) can be imaged in the lung, muscle and nasopharynx of long COVID patients (with dyspnea and fatigue). However, these preliminary data are derived from a selective group of patients with long COVID after critical COVID-19. We aim to explore the generalizability of these findings in patients with long COVID with dyspnea and fatigue, irrespective of the severity of their acute SARS-CoV-2 infection.

Primary objective: To assess if pulmonary fibroblast activity, measured by \[68Ga\]FAPI-46 PET/CT, is higher in patients with current long COVID dyspnea and fatigue compared to patients with resolved complaints.

Study design: This is a ZonMw funded single centre prospective observational cohort study of long COVID-19 patients with dyspnea and fatigue.

Study population: We will recruit 60 adult long COVID patients (aged \>20 years) of which 30 have complaints of dyspnea and fatigue and compare them to 30 patients with resolved complaints and healthy controls.

Main study parameters/endpoints: The primary endpoint is FAP expression in the lung measured by \[68Ga\]FAPI-46 PET/CT. Secondary endpoints are the expression of FAP in other tissues (muscle) and the relation between FAP and inflammation and remodelling biomarkers in various biological samples (e.g. serum/nasal epithelium).

Study procedures: In a single visit day the following data and samples will be collected: questionnaires, a lung function test, 6-minute walking test, blood samples, nose swabs, \[68Ga\]FAPI PET/CT scan and HRCT scan. When increased \[68Ga\]FAPI uptake is measured in the muscles a muscle biopsy will be performed as well.


Eligibility Criteria:
Inclusion Criteria:

- Self-reported complaints of dyspnea or fatigue \> 3 months after SARS-CoV-2 infection confirmed with PCR, serology test or COVID-19 Reporting and Data System (CO-RADS) score 4/5.

Exclusion Criteria:

* Inability or unwilling to give informed consent.
* History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans.
* Individuals who are pregnant or currently breastfeeding are not eligible to participate
The Effect of Basic Body Awareness Therapy on Musculoskeletal Disorders and Psychological Symptoms

During the coronavirus disease (COVID-19) pandemic, stay-at-home isolation as a precaution to alleviate the disease has affected the physical and mental well-being of individuals. University students spent time in front of the screen with online education and developed a sedentary lifestyle during the academic term. In this process, musculoskeletal disorders increased more in university students due to the increase in the use of laptop or computer, smartphone, and social media. The COVID-19 pandemic has caused psychological disorders as well as physical health problems. General population studies have shown that all forms of depression, anxiety, stress, sleep problems, and psychological distress are highly increased during this period. In a study conducted in Turkey, it was reported that students' negative well-being, anxiety, and physical inactivity significantly affected perceived stress during the COVID-19 pandemic, and students' mental health was at high risk. It has been stated that providing mental health supportive systems in students and encouraging physical activity regularly can reduce perceived stress levels.

On the other hand, psychological interventions via video conferencing platforms have been proposed to promote mental health due to the limited and delayed face-to-face healthcare as a result of the COVID-19 pandemic. It has been stated that the use of telemedicine or e-health applications together with body-mind approaches such as yoga, tai chi, qigong may be beneficial in order to encourage physical activity and protect mental health in this critical period. Basic Body Awareness Therapy (BBAT), which is among the body-mind approaches, is also frequently used in the rehabilitation of patients with psychiatric disorders, pain, and chronic musculoskeletal system problems. Therefore, the aim of this study is to evaluate the effect of BBAT on musculoskeletal disorders and psychological symptoms in university students who participated in the hybrid (online + face-to-face) education program during the COVID-19 pandemic. The importance of this study is that it is the first study on physical and psychological symptoms of BBAT in university students.


Eligibility Criteria:
Inclusion Criteria:

* Being studying at Bandirma Onyedi Eylul University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
* Volunteering to participate in the study
* Being between the ages of 18-25

Exclusion Criteria:

* Having any diagnosed psychological disorder
* Regularly doing body-mind approaches such as yoga and tai chi
* Having any condition involving the musculoskeletal system
* Having a rheumatic disease
Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)

The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol# CTP-0001-00).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Men and women 22-68 years of age
* Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV).
* Completed the CTP-0001-00 study according to the protocol, i.e., either completed 16 weeks of treatment, or were discontinued from the CTP-0001-00 study protocol after 6 weeks or more from randomization.
* Capable and willing to provide informed consent.
* Able to adhere to the treatment schedule.

Exclusion Criteria:

* Discontinued from CTP-0001-00 study protocol due to the following reasons: Tolerability and safety reason, Non-compliant with the study protocol, Developed documented suicidal ideation as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or suicidal attempt
* Current psychotic disorder
* Sensitivity or allergic or other severe adverse event previously reported for Citalopram, Escitalopram, Fluoxetine, Paroxetine, or Sertraline.
* Known or suspected pregnancy
* Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
* Minimal MT found for both hands is higher than 75% of stimulator power output.
Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)

The goal of this clinical trial is to learn if Pressurized intraperitoneal aerosol chemotherapy (PIPAC) significantly improve the progression-free survival (PFS) in patients with advanced peritoneal metastasis from colorectal cancer.

Researchers will compare 2 strategies, systemic treatments (chemotherapy + targeted therapy) corresponding to standard treatment with or without intraperitoneal oxaliplatin (PIPAC) to see if PIPAC improve the progression-free survival.

Participants will:

* receive a standard treatment every 2 weeks for 12 cycles of intravenous FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF) in the both arms.
* receive up to a maximum of 4 PIPAC every 6 weeks with pressurized aerosol containing oxaliplatin in experimental arm.
* receive a maintenance treatment until progression or until the onset of severe toxicity after 12 cycles.
* be asked to perform a CT scan and carcinoembryonic antigen (CEA) assay every 8 weeks until progression


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 to 2;
* Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);
* Unresectable PM defined as any of the following:

  * PCI \>15
  * Extended small bowell involvement
  * Poor general condition contra-indication to a major abdominal surgery (eg: a complete cytoreductive surgery), as decided by the medico-surgical team of the investigator's site specialised in peritoneal carcinomatosis in charge of the patient.
* A surgical exploration performed less than 4 weeks before inclusion (if not, a laparoscopic exploration must be performed);
* First line systemic chemotherapy for advanced / metastatic colonic adenocarcinoma. Systemic chemotherapy in an adjuvant setting is allowed if completed more than 6 months before recurrence and without persistent oxaliplatin-induced neuropathy;
* No extended intraperitoneal adherences defined by at least 9 out of 13 abdominal regions correctly explored during surgical exploration (laparoscopy or laparotomy;

Exclusion Criteria:

* Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;
* Rectal cancer primary (tumor \<15 cm from the anal verge);
* Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);
* Complete or partial bowel obstruction unresponsive to medical treatment;
* Extraperitoneal polymetastatic diseases. (Only oligometastatic1 diseases are allowed for inclusion);
* History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months prior to enrolment;
* Active gastrointestinal bleeding;
* Inflammatory bowel disease;
* Peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0, grade ≥2
A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion

This is a phase II open label study for patients with p53-deleted CLL who require treatment. Both untreated and previously treated patients are eligible for study entry.

The trial consists of giving continuous alemtuzumab and cyclical high-dose methyl-prednisone.Alentuzumab is given intravenously during the first 4 weeks of treatment to ensure that adequate serum levels are achieved quickly. The drug will be administered daily during the first week, commencing at a dose of 3mg, and increasing to 10mg and then up to the target dose of 30mg as tolerated.Thereafter alemtuzumab will be given at a dose 30mg thrice weekly. From week 5, alemtuzumab will be given at the same dose but by the subcutaneous route of administration.

Methlyprednisolone will be given for 5 consecutive days at a daily dose of 1.0g/m2, starting on Day 1 and repeating the cycle every 28 days.

Treatment will be given for 16 weeks (i.e 4 cycles of methylprednisolone). Treatment will be discontinued if there is no response after 8 weeks, or if toxicity becomes unacceptable.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Written informed consent
* Confirmed diagnosis of CLL or SLL (small mature lymphocytes n blood, bone marrow or lymph nose expressing CD19, CD5, CD23, weakk CD79b, and weak clonally restricted immunoglobin light chain)
* p53 deletion by FISH in at least 20% of leukamia cells
* Treatment is indicated (Binet stage B or C, or stage A with a lyphocyte doubling time of less than 6 months, or disease-related symptoms or complications irrespective of clinical stage)
* WHO performance status 0, 1 or 2
* Both untreated and previously treated patients are eligible for study

Exclusion Criteria:

- Patients must have none of the following: Active infection Known HIV infection Past history of anaphylaxis following exposure to rat or mouse CDR-grafted humanised monoclonal antibodies Less than 3 weeks since prior chemotherapy Use of prior investigational agents within 6 weeks Pregnancy or lactation Uncontrolled diabetes mellitus Uncontrolled hypertension Active peptic ulcer disease Other severe concurrent diseases or mental disorders Serum urea or creatinine more than twice the upper limit of normal (unless due to uretic obstruction or renal infiltration by CLL/SLL) Serum bilirubin more than twice the upper limit of normal (unless due to haemlysis or liver infiltration with CLL/SLL) Persisting severe cytopenias due to previous therapy rather than disease (neutrophils \<0.5 x 109/l or platelets \<50 x 10/l)
A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients on hemodialysis
* Hyperphosphatemia
* Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention
PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO

It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.


Eligibility Criteria:
Inclusion Criteria:

* Patient given the sedatives, analgesics and antibiotics of interest during ECMO.
* Age from 18 to 85 years old.
* Multiple blood sampling is acceptable.

Exclusion Criteria:

* Patients who are allergic to the investigated drugs.
* Patients who are pregnant.
SPL Insufficiency Syndrome (SPLIS)/NPHS14: a SPLIS Observational Study and Patient Registry (International)

This protocol aims to gather information about sphingosine phosphate lyase insufficiency syndrome (SPLIS), also known as NPHS14, and to create a SPLIS patient registry. Medical records, radiological and pathology results, blood test results, and genetic information will be collected. Samples of blood, cheek cells, urine and stool may be collected for analysis. If a skin biopsy has been performed for medical care, cells from the biopsy may be analyzed. No treatment or other intervention is involved in this study. However, the effect of treatments administered by the patient's physician may be detected and monitored based on changes in the blood or urine.

This protocol aims to gather information about sphingosine phosphate lyase insufficiency syndrome (SPLIS), a condition also known as NPHS14 or familial steroid-resistant nephrotic syndrome with adrenal insufficiency. SPLIS is a recently discovered genetic disease caused by recessive mutations in the SGPL1 gene. SPLIS can have effects on the kidney, adrenal gland, brain, skin, and blood cells. Some patients with SPLIS do not survive beyond infancy, whereas others live to adulthood. By monitoring the natural history of SPLIS over time in affected patients, the investigators will establish a clinical baseline that reflects how the disease progresses over time. This information may be useful in future clinical trials. The results may reveal which types of SGPL1 mutations correlate with best and worst patient outcomes. Some SPLIS patients are current on a regimen of high dose vitamin B6 supplementation on the advice of their treating physician. By including patients treated with B6, our study may provide evidence for the impact of B6 treatment on biochemical and blood markers of the disease. Our overall goals are to characterize the clinical, biochemical and metabolic manifestations of SPLIS and how these manifestations change over time within individuals with this condition.

Eligibility Criteria:
Inclusion Criteria: Individuals of all ages diagnosed with SPLIS based on bi-allelic pathogenic variants of SGPL1, including children and neonates, as well as family members or caregivers, healthy volunteers and individuals with other sphingolipidoses.

Exclusion Criteria: the investigators will not include:

* prisoners
* pregnant women
* healthy volunteers with:

  * diabetes,
  * infection,
  * fever,
  * known HIV/AIDS,
  * cardiac disease
  * or anemia.
Silastic Versus Conventional Drain in Thoracic Surgery

In thoracic surgery, it is usual to place apical and basal drains for complete drainage of air and fluid out of the pleural cavity. The routinely used drains are mainly made of plastic. Recently silastic drains of smaller size are used without any complication. The investigators designed a prospective randomized trial to compare the draining properties of the two types of drains following various resections in thoracic surgery.

Following the Institutional Review Board permission (permission no: 2009/27) the investigators started to recruit patients for the study in June 2009. Pneumonectomy, decortication, and diaphragm plication patients were not included in this study. The patients were consecutively placed in one of the two groups. In Group I, an apical 28FR size CD, and a basal 19FR SD were placed following surgery. In Group II, the apical drain was 28FR, and the basal drain was 32FR CDs. Basal drains were removed out when daily serous fluid drainage became 200 ml or less, and the apical were removed 48-72 hours following the cessation of air leak. The patients were discharged on the day after drain removal. The data concerning gender, age, diagnosis, operation side, type of operation, amount of fluid drainage, duration of fluid and air drainage, length of hospital stay, and complications if any, were noted.

Eligibility Criteria:
Inclusion Criteria:

* Candidates of surgery willing to participate in the experimental arm of the study and signing the informed consent form.

Exclusion Criteria:

* Pneumonectomy, diaphragm plication, and decortication candidates
Effect of Scapular Mobilization on Patients With Scapular Pain

The purpose of this study is to determine the effect of scapular mobilization on pain related parameters including pain intensity, pressure pain threshold, muscle tension, anxiety, Scapular range of motion, patient satisfaction in patients with scapular pain associated with myofascial trigger point:


Eligibility Criteria:
Inclusion Criteria:

* The participants have experienced spontaneous scapular pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the muscles surrounding the scapula. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
* The participants will be able to follow instructions.
* Good communication and cooperation.

Exclusion Criteria:

* Shoulder impingement syndrome
* Adhesive capsulitis
* Shoulder instability
* Shoulder arthritides
* Shoulder dislocation and/or bone fracture
* Hypermobility of shoulder joint
* Open wound
* Drug and/or alcohol intoxication
* Contraindications of mobilization
Aversive Therapy for Smoking Cessation

The purpose of this research study is to test a new way to help people quit smoking. The PI will test acceptability and feasibility of a new device called Pavlok wearable wrist band. Participants will be smokers who are highly motivated to quit. Participants will be randomized into intervention and control groups.

The participants will be evaluated after 1 week and assessed for their ongoing participation and commitment to the study. Those still interested and eligible will be randomized to two groups described below and will continue the study for 3 more weeks. There will be follow up surveys at various time points while wearing the wristband (1 week, 2 week, 3 weeks) and a final survey at T=3 months.

The intervention group will continue to wear the wristband and the wristband will deliver a slight electric stimulus every time it is pressed.

The placebo group will wear continue to press the button on the wristband but it will not give a slight electric stimulus when pressed. Both groups will wear the device for a total of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker (defined by the Center for Disease Control as an "adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes ". This will be determined based on participant baseline survey.
* Interested in quitting (contemplation stage and beyond, as defined by serious consideration of quitting smoking in the next 30 days
* Subject is equal to or greater than 19 years old
* Considers themselves "tech savvy" (based on self reported 5 point likert scale)
* Must have a smart phone with blue tooth capabilities
* Willing to receive aversive therapy if assigned to this group.

Exclusion Criteria:

* Anyone with a diagnosed arrhythmia or with a pacemaker or with a phobia or history of psychosis.
* Non-English speaking caregivers
* Lives outside of contiguous United States