cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis

Depression is second in frequency only to hypertension as a comorbid condition for End Stage Renal Disease (ESRD) patients. The presence of depression has been linked to lower quality of life, more medical comorbidities and shorter lifespan. This project represents the first known attempt at a standardized intervention for depression in ethnically diverse ESRD patients. The study will be conducted at the Parkside Center for Dialysis. Patients will be randomly selected for screening until 80 subjects meet entry criteria and agree to be randomized. Once subjects are screened and enrolled in the study they are randomly assigned to either a treatment or wait-list control condition. After 3 months, the intervention will be completed and both groups will be reassessed. After an additional 3 months, both groups will have received the intervention and pre and post measures for both groups will be available as well as 3 month follow-up for the 1st intervention group.

The following measures will be collected: to obtain a full DSM-IV diagnosis the SCID I and SCID II will be utilized. The BDI will provide a self-report measure of depression. The Hospital Anxiety and Depression Scale (HADS), a measure designed specifically for medically ill patients, will also be administered. Additionally, the Young Schema Questionnaire, a measure which seeks to identify maladaptive (both depressive and anxious) cognitive styles, will be administered. A quality of life measure designed specifically for dialysis patients (KDQOL-SF) will also be given as a means of measuring patient's overall coping and functioning. To better understand the patient's perceptions of their health and illness the Illness Effects Questionnaire will be administered. A demographic information sheet will be completed by the subject in which personal, ethnic, and illness information is collected. Detailed information about the subject's mental health history and treatment as well as current medications will be gathered. Data from routine dialysis laboratories (hemoglobin, creatinine, albumin, Kt/V) will be extracted from the chart.

The intervention will take place in individual format while the subjects are being dialyzed. The intervention will be 10 sixty minute -long weekly sessions spread over not more than 3 months. It will include both cognitive and behavioral skills focused on alleviating depressive affect and identifying maladaptive patterns of thought and behavior. This study would lay the groundwork for future clinical research by helping to develop a culturally competent clinical intervention and demonstrate the feasibility and effectiveness of adapting psychosocial intervention for a medically complex culturally diverse population.


Eligibility Criteria:
Inclusion Criteria:

- hemodialysis patient Depression diagnosis

Exclusion Criteria:

(1) presence of current organic mental disorder (2) schizophrenia (3) bipolar disorder (4) depression with psychotic features (5) current substance abuse or dependence (6) active suicidal intent or plan (7) active homicidal ideation, intent, or plan -
A "physician & Patient-powered" Cohort Registry (MY MYELOMA)

The aim of this observational study is the creation of a national multiple myeloma registry to monitor the current routine clinical practice in Italy and describe the standard of care adopted for the diagnosis and treatment of patients with multiple myeloma in the different Italian hematology centers.

In Italy, myeloma accounts for 1.3% of all tumour diagnoses in males and for 1.2% of all tumour diagnoses in women. The incidence is 9.5 new cases per 100,000 males and 8.1 cases per 100,000 females. Median age at diagnosis is 68 years and approximately 2% of patients experience onset before the age of 4011. Therefore is to establish a national disease registry to monitor current routine clinical practice in Italy and to describe the standard of care adopted for the diagnosis and treatment of patients with myeloma. National registries have already been established in some countries and a recently-published meta-analysis highlighted certain differences in treatment, survival and the demographic characteristics of patients. An Italian national registry is important for analysing the current situation, in order to deal with the changes that lie ahead. In addition to the standard epidemiological registry - as described in the statistical methods section - a patientpowered registry (PPR) will also be established to encourage patient participation.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Age ≥ 18 years
* Diagnosis of active/symptomatic multiple myeloma (according to CRAB and biological parameters) no earlier than 1st January 2019
* Able and willing to sign an informed consent form

Exclusion Criteria:

* None considered
Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function

The results of this study may or may not establish useful baseline data, which will help us understand how bone marrow derived adult liver stem cells behave in normal healthy adults/volunteers (the control group), and in patients undergoing liver surgery. The bone marrow is located within your bones and is the organ which is responsible to produce blood cells and stem cells. Bone marrow derived adult liver stem cells are normal cells in your bone marrow. These liver stem cells have the capacity to regenerate or in other words to rebuild the liver after liver surgery, a process called liver regeneration. These cells are very important for the liver to regrow its tissue after liver surgery. These cells are thought to be activated in times of need by the liver.

Situations like liver surgery are one of these occasions when the liver will need the "extra help" from these stem cells.

The results of this study will establish the baseline data necessary for the understanding of how to harness the ability of these stem cells in times of liver surgery. Improvements in the ability of the liver to regrow after surgery is thought to decrease complications related to liver surgery. Harnessing this unique ability of stem cells may be utilized in the future to enhance the regrowing process of liver tissue after liver surgery, called liver regeneration.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ or equal to 18 years old).
* Patients scheduled for resection of 3 or more liver segments for any indication, with or without other planned procedures.

Or

* Normal healthy volunteers (control).

Exclusion Criteria:

* Chemotherapy or GCSF treatment in the preceding 4 weeks.
* CHILD'S classification B or above.
* Presence of active infection.
* History of lymphoma or leukemia.
* Normal healthy volunteers who underwent chemotherapy treatment at any stage of their life will be excluded.
* Normal healthy volunteers who are under any active treatment for any active illness will be excluded.
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease

For patients admitted to the medical ward, it is usually difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the number and duration of cardiopulmonary micro events during the first 4 days after hospital admission with Acute Exacerbation of COPD. We will also test the server installation, develop a database of core data and assess the frequency of artefacts and failure to capture the continuous monitoring signal.


Eligibility Criteria:
Inclusion Criteria:

Adult patients admitted to hospital for Acute Exacerbation of COPD (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.

Exclusion Criteria:

* Patient expected not to cooperate.
* Patient allergic to plaster, plastic or silicone.
* Active therapy withdrawn
Intubation During Spinal Immobilization

The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* limited experience (\<5 intubations) with "real-life" intubation using direct laryngoscopy
* novice phhysicians

Exclusion Criteria:

* not meet the above criteria
* practice with any videolaryngoscopy
* wrist or low back diseases
* pregnancy
Effect of Per-cutaneous Nephrosotomy Drainage on Radioisotope Imaging of Hydronephrotic Kidneys

Hydronephrosis describes a condition of urine-filled dilation of the collecting system. Normally, urine flows through the urinary tract with minimal or low pressure. If the build-up of excess fluid in the urinary collecting system continues, there will be an increase in pressure and atrophy of renal cortex. If hydronephrosis is left untreated for a long time, renal damage with permanent loss of function occurs


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients for whom a percutaneous nephrostomy is indicated provided that the hydronephrosis is advanced ( parenchymal thickness not more than 5 mm ) 2) Patients for whom a nephrectomy is planned for a seemingly poorly functioning kidney along with either

Exclusion Criteria:

1. Target kidney is the only functioning or better functioning kidney or otherwise substantially contributing to the total renal function, so nephrectomy is not likely.
2. Emergency cases where the general condition of the patient cannot withstand the logistics of undergoing a radioisotope study eg
3. Malignancy in the target kidney
4. Patients unlikely to undergo a nephrectomy
Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear

Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score, functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural evaluation using MRI at 24 weeks after injection.


Eligibility Criteria:
Inclusion Criteria:

Participants must;

1. Be 19 years of age or older.
2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade I, II assessed by MRI.
3. Have unilateral shoulder pain lasting more than 3 months despite conservative treatment and VAS pain score ≥5 at screening.
4. Understand fully the study and voluntarily sign the informed consent for participation in the study.

Exclusion Criteria:

Participants with any of the following conditions will be excluded unless stated otherwise;

1. Have partial-thickness rotator cuff tear larger than 50% of tendon thickness or of Ellman grade III, or full-thickness rotator cuff tear confirmed by MRI.
2. Have prior medical history of shoulder surgery on the torn rotator cuff or the upper part of shoulder within 6 months prior to screening visit (shoulder trauma, fracture, upper cervical spine surgery, etc.).
3. Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
4. Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
5. Have been diagnosed with the following diseases.

   * Inflammatory joint diseases
   * Other shoulder diseases which may cause shoulder pain or functional disorder
   * Autoimmune diseases
   * Active hepatitis B or C
   * HIV Ab positive
   * Malignant tumors within the last 5 years
   * Coagulopathy
   * Genetic disorders related to fibroblasts of collagen
   * Other serious diseases deemed to affect the results of the study
6. Have allergies to bovine proteins or gentamicin.
7. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
8. Have participated in other clinical trials and received investigational agents within 4 weeks of this study
9. Be deemed inadequate for the study by investigators.
PAC-14028 in Healthy Male Volunteers

1. Primary Objective:

   * To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
2. Secondary Objective:

   * To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral dosing of PAC-14028 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men aged 20 to 45 years at the time of screening
2. Whose weight is 50kg or more, but less than 90 kg, and whose body mass index(BMI) is 19.0 kg/m\^2 or more but less than 27 kg/m\^2

   -BMI (kg/m\^2) = weight(kg) /{height(m)}\^2
3. Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.

Exclusion Criteria:

1. Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system, psychical disorders or blood tumor
2. Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty )
3. Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
4. Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
5. Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
6. Smoker or who has stopped smoking within previous 1 month or shows positive result at cotinine test.
7. Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
8. Who consistently consumes alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol)
9. Who has participated in other clinical study within 12 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.)
10. Who has had bleeding or blood collection and donation over 400 mL within 12 weeks before study drug administration
11. Whose vital sign measured at sitting position after resting at least 5 minutes is as following

    * Low blood pressure (Systolic pressure: 90 mmHg or less, Diastolic pressure: 50 mmHg or less)
    * High blood pressure (Systolic pressure: 140 mmHg or higher, Diastolic pressure: 90 mmHg or less)
12. Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.
Use of Erbium Laser for Extraction of the Third Molars

A comparative analysis of the effectiveness of the erbium laser with the wavelength of 2.94 µm and traditional instruments in the extraction of the impacted lower third molars will be performed. Clinical, radiological and biochemical findings will be assessed after extraction of the impacted lower third molars.

A single-centre, interventional, non-randomized, prospective clinical trial in 2 parallel groups is planned. The lower third molars will be extracted in 60 patients. There will be 2 groups. The number of men and women in both groups will be the same, the patients age will be between 18 and 70 years. In the study group the lower third molars will be extracted using erbium laser with a wavelength of 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245), in the control group the lower third molars will be extracted using the conventional method (cutting and rotating instruments). Postoperative clinical symptoms such as collateral soft tissue swelling, postoperative pain, trismus in the extraction site and healing time (epithelization and bone regeneration) will be assessed. The epithelization will be assessed after 7, 10, 14 days. The bone regeneration will be assessed by cone beam computed tomography (KAVO, ORTHOPANTOMOGRAPH ОР 3D, type: РСХ-1; registration № РЗН 2020/10586) after 1, 3, 6 months. The radiation exposure will not exceed the permissible limits. Biochemical indicators in the saliva will be assessed before extraction, after extraction, 3 days and 7 days after the extraction. The Shapiro-Wilk test will be applied to check the normality of variable distribu- tion. Qualitative variables will be analyzed by Pearson's chi-squared test. Quantitative variables (normal distribution of variable) will be analyzed by Students t-test, non-normal distribution of variables will be analyzed by Mann-Whitney U test.

Eligibility Criteria:
Inclusion Criteria:

1. Signing of written informed consent of the patient to participate in a study
2. Age from 25 to 50 years old
3. Indications for impacted third molar extraction
4. Patients who are medically stable
5. Therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity)

Exclusion Criteria:

1. Refusal of the patient from further participation in the study
2. Pregnancy diagnosed after the inclusion into the trial
3. Non-compliance by the patient with postoperative recommendations
4. Absence of a lower second molar
Prospective Study of Lymphoproliferative Diseases

This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will let the resesarchers look at their medical record, follow their normal cancer care, and have blood drawn to look at different proteins and viruses. Researchers would also like to look at part of the original tumor that was taken out of each patient. Some of these samples will be stored at Kenyatta National Hospital and research will be done on them later. This study does not involve any change in treatment, but only allows the study team to follow how a patient in Kenya with lymphoma is treated.

Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.

Eligibility Criteria:
Inclusion Criteria:

* All subjects regardless of age, sex or HIV serostatus must have biopsy-proven non-Hodgkin's (NHL), including primary effusion lymphoma, Hodgkin's lymphoma (HD) or other lymphoproliferative disorder (e.g., Castleman's disease) with measurable or evaluable stage I through IV disease.

\[Note: Lymphomas will be categorized on the basis of current WHO classification scheme, but it is recognized that initial pathological categorization at time of study enrollment will more than likely be classified or graded as low-, intermediate-, or high-grade lymphoma by Working Formulation criteria. This is the current standard of practice in Kenya.\]

* All subjects must receive some form of systemic chemotherapy. Subjects not receiving chemotherapy of any kind are not eligible. Subjects must not have had any prior chemotherapy for lymphoma.
* Subjects may have received prior radiotherapy for localized stage I or stage II disease that is clearly documented to have progressed beyond initial radiotherapy ports.
* All subjects must give written informed consent to participate on study. In Kenya, a child is considered \< 18 years of age and an adult ≥ 18 years of age. All children will have their parental or legal guardian provide consent.. Children between the ages of 7 and \< 18 years old should be given the opportunity to provide their assent. For children between the ages of 7 and 11 years old this should be done using the parental consent form assent statement. For children \> 11 years old assent should be documented using the IRB approved assent form.

Exclusion Criteria:

* Subjects who do not fulfill the criteria as listed in Sections 3.1.1 through 3.1.4 are ineligible.
* Subjects who received prior chemotherapy (i.e., first-line treatment) or are not receiving any chemotherapy for their non-Hodgkin's (NHL) or Hodgkin's lymphoma (HD) are ineligible.
Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)

Neonatal mortality rate is the highest in Pakistan. And Birth Asphyxia is one of the main reversible causes. Outcomes related to birth asphyxia can be improved, if intervention done in time with proper measures. MgSO4 is cheaper and easily available drug.

Some studies showed positive results if given within 6 hours of birth asphyxia, whereas some are not supportive. But still less know about this drug, especially in low income countries. Objective of this study is to see beneficial effects of MgSO4 in neonates presenting with birth asphyxia.

Eligibility Criteria:
Inclusion Criteria:

* After informed consent, any child who is term, inborn or out born fulfilling the definition of hypoxic ischemic encephalopathy according to history, apgar or scoring system and reaching within 6 hours of delivery in nursery department of pediatric medicine unit-II, Services Hospital, Lahore

Exclusion Criteria:

* Preterm Syndromic/dysmorphic child Term child with HIE and arriving after 6 hours of life. Term child with unrelated co morbidities eg congenital heart defects, Renal failure etc