cyrilzakka/clinical-trials huggingface dataset:
Expand New Drugs for TB [endTB]

This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who receives a treatment regimen containing bedaquiline or delamanid at an endTB site will be invited to participate in this observational study, regardless of age or gender.
* Any patient who signs the study informed consent form will be included in the study.

Exclusion Criteria:

* Refusal to participate in the study.
Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Phase II trial to study the effectiveness of docetaxel in treating patients who have persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of docetaxel in patients with persistent or recurrent squamous cell carcinoma of the cervix.

II. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed persistent or recurrent squamous cell carcinoma of the cervix
* Progressive disease
* At least 1 unidimensionally measurable target lesion

  * At least 20 mm by conventional techniques
  * At least 10 mm by spiral CT scan
  * Tumors within a previously irradiated field are not considered target lesions
* One prior systemic chemotherapeutic regimen for advanced, metastatic, or recurrent squamous cell carcinoma of the cervix required

  * Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen
* Ineligible for a higher priority GOG protocol (e.g., any active Phase III GOG protocol or GOG-0076)
* Performance status - GOG 0-2
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* No congestive heart failure
* No unstable angina, myocardial infarction, or new cardiac arrhythmia within the past 6 months
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No greater than grade 1 sensory and motor neuropathy
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* At least 3 weeks since prior biologic or immunologic therapy directed at malignant tumor
* One prior noncytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease allowed
* Recovered from prior chemotherapy
* No prior docetaxel
* No more than 1 prior cytotoxic chemotherapy regimen
* At least one week since prior hormonal therapy directed at malignant tumor
* Concurrent hormone replacement therapy allowed
* Recovered from prior radiotherapy
* Recovered from recent prior surgery
* At least 3 weeks since any prior therapy directed at malignant tumor
* No prior anticancer therapy that would preclude study
* No concurrent amifostine or other protective agents
Communication in Breast Cancer Care

The investigators will create 4 information-video's about chemotherapy side-effects in curative breast cancer care. The communication is manipulated in the four videos. Participants will watch the video before the first chemotherapy and complete questionnaires before and after viewing the video and after chemotherapy 1,2 and 4. (The investigators cannot yet reveal the manipulation as it would influence the participants)

NA, the investigators cannot yet reveal the manipulation as it would influence the participants.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years old) female breast cancer patients
* Chemo-naïve patients
* Scheduled in for curative neo-adjuvant chemotherapy: Four courses of AC chemotherapy (all combinations of AC + other chemotherapy courses are eligible)
* Cognitively able to fill out an online questionnaire
* Having internet access
* Sufficient command of the Dutch language
* pre-chemo no previous treatment or pre-chemo breast-conserving surgery and radiotherapy (WLE patients)

Exclusion Criteria:

* NA
Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil

OBJECTIVE:

Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.

PROTOCOL OUTLINE:

This is a randomized study. Patients are stratified by participating institution.

One group is treated with daily intramuscular injections of glucantime. Patients with less than a complete response on Day 21 continue treatment until lesions heal completely or for a maximum of 60 days. Patients with progressive disease on Day 40 are removed from study.

The second group is treated with daily oral allopurinol. Patients with a partial response on Day 21 continue treatment until lesions heal completely. Patients with stable or progressive disease on Day 21 or unhealed lesions on Day 56 cross to glucantime therapy. Accrual into this group was closed in 6/96.

The third group receives allopurinol and glucantime.

Patients are followed at 3, 6, and 9 months, then annually for at least 5 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Parasitologically confirmed cutaneous leishmaniasis (lesion of less than 3 months duration)

No mucocutaneous leishmaniasis

No prior leishmaniasis

--Prior/Concurrent Therapy--

No prior treatment for leishmaniasis

--Patient Characteristics--

Hepatic: No clinical or laboratory evidence of hepatic disease

Renal: No clinical or laboratory evidence of renal disease No hyperuricemia or gout

Cardiovascular: No clinical, electrocardiographic, or laboratory evidence of cardiac disease

Other: No allergy or other contraindication to allopurinol or glucantime; No concurrent medication that might interact with study drugs, e.g.: probenecid, warfarin, azathioprine; No skin rash; No malnutrition; No other medical contraindication to protocol therapy; No pregnant or nursing women
Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities

Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal low vitamin D level is a well known problem for our country and the level was reported as \<10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Term or preterm newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital

Exclusion Criteria:

* Preterm babies born before the 24. gestational week
* Babies with complex cardiac anomalies and/or dysmorphic features
ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF

The primary objective of the following randomized open label trial is to demonstrate how low immunological risk patients (no anti HLA immunization and first kidney transplantation) but diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from induction with ATG for preventing delayed graft function compared to Basiliximab.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* First kidney transplantation
* No anti HLA immunization prior transplantation
* A risk of DGF higher than 40% calculated by the score DGFS (DGFS \>= 0.4)
* Written informed consent

Exclusion Criteria:

* Previous or combined other transplantations
* Non heart beating donors
* Living donors
* Pre-emptive transplantation
* Patients on peritoneal dialysis
* Leucopenia lower than 3000/mm3
* Thrombopenia lower than 100 000/mm3
* Donor EBV positive / recipient EBV Negative
* Pregnant or lactating women
* Patients under guardianship
* Previous and current history of cancer and/or lymphoma
* Current history of HCV or HBV or HIV infection
The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome

The aim of this project is to determine the effect of compression stockings on the complaints, well-being and sleep quality of pregnant women with restless legs syndrome (RLS). The research is a pretest-posttest randomized placebo-controlled experimental study. The study will be carried out with a total of 70 people, 35 in the compression stocking group and 35 in the placebo stocking group. Study data will be collected with RLS Diagnostic Criteria Questionnaire Form, Research Criteria Compliance Form, Personal Information Form, RLS Severity Rating Scale, Pittsburgh Sleep Quality Index (PUKI), WHO-5 and Implementation Satisfaction Form. Pregnant women in both groups will wear the stockings given for three weeks after the first interview.

Data analysis obtained in the research will be performed in TURCOSA statistical software (Turcosa Analytics Ltd Co, Turkey, www.turcosa.com.tr).In comparisons, a value of p \<0.05 will be considered statistically significant. In order to conduct the study, the necessary Academic Committee decision, Ethics Committee approval (December 08, 2021 and number 2021/781) and institutional permission were obtained. The individuals included in the study will be informed about the purpose of the research, their verbal consent will be obtained and the participant's informed consent form will be signed.


Eligibility Criteria:
Inclusion Criteria:

1. Least literate,
2. Between the ages of 18 and 40,
3. At 27 and above gestational week,
4. Single pregnancy,
5. Presence of RLS according to the RLS Diagnostic Criteria Questionnaire Form,
6. Having a severity of 11 and above according to the RLS Severity Rating Scale,
7. Using Iron, Vitamin D, Magnesium and Calcium,
8. Pregnant women with a hemoglobin level of 11 g/dl and above,
9. Pregnant women who can wear socks all day long, except for going to sleep, will be included in the study.

Exclusion Criteria:

1. Having a communication barrier,
2. Having a risky pregnancy (risk of preterm labor, cervical insufficiency, preeclampsia, polyhydramnios, macrosomic baby, etc.),
3. Having RLS before pregnancy,
4. Having a chronic disease (Diabetes, hypertension, thyroid, cardiovascular disease, etc.),
5. With maternal obesity (BMI\>30)
6. Having sleep apnea before pregnancy,
7. Having any psychiatric disease and using antipsychotic and antidepressant drugs,
8. Using heparin, antihistamine, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs,
9. Having a dermatological problem in the feet and legs,
10. Pregnant women with varicose veins on their feet and legs will not be included in the study
Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants

It shall be investigated whether ventilated neonates and infants with a remifentanyl based analgesia and sedation can be extubated faster after discontinuation of the opioid infusion compared to neonates and infants with a fentanyl based analgesia and sedation.

"Newborns (≥ 36 weeks of gestation) and young infants (≤ 60 days) with need of mechanical ventilation receive next to midazolam either remifentanyl or fentanyl for analgesia and sedation. The study medication will be started not later than 12 hours after intubation and the maximum application time is 96 hours. The opioid infusion rate is started with either 9µg/kg/h remifentanyl or 3µg/kg/h fentanyl and will be adapted according to a clinical sedation score (Hartwig- and Comfort score). The maximum infusion rate is 30µg/kg/h remifentanyl or 10µg/kg/h fentanyl.

To judge the efficacy of both opioids, we will evaluate the sedation scores every 6 hours and measure the skin conductance during a painful procedure (tracheal suctioning). Next to the adverse events we document different vital parameters like heart rate, blood pressure or oxygen saturation every 6 hours to estimate the safety of both opioids.

The midazolam plasma level will be determined immediately before termination of the opioid and midazolam infusion when the child is clinically judged to be ready for extubation. The child will be extubated as soon as it reaches a certain level in the sedation score and exhibits stable spontaneous breathing.

After extubation we will look in both treatment groups for the possible development of hyperalgesia by investigating the cutaneous flexor reflex with von Frey hairs. The trial ends for each patient 48 hours after extubation.

Eligibility Criteria:
Inclusion Criteria:

* Ventilated term newborns and infants ≤ 60 days
* Expected time of artificial ventilation between 12 and 96 hours

Exclusion Criteria:

* Neuromuscular diseases
* Drug abuse of the mother (exclusion criteria for newborns)
* Known hypersensitivity to Ultiva® or Fentanyl-Janssen®
* Missing informed consent of the parents
* Participation in another clinical trial during the last 4 weeks before start of this trial
Respiratory Resistance Training on Sleep Quality in Persons With Spinal Cord Injury

The purpose of this study is to determine if the use of a respiratory resistance trainer will increase respiratory muscle strength, improve sleep quality and improve quality of life in individuals with spinal cord injury.

Hypothesis: Use of the respiratory resistance trainer will improve respiratory muscle strength, improve sleep quality, and improve quality of life among individuals with spinal cord injury.

Individuals with spinal cord injury experience varying degrees of reduced muscle function. Those individuals with high level spinal cord injury, cervical region, may experience reduced diaphragm function. This reduction in function may affect daytime activities as well as sleep quality. Sleep quality in people with spinal cord injury is considered to be worse than sleep quality in the general population. The use of respiratory resistance training devices has been shown to increase muscle strength in people with spinal cord injury. There have been not studies to document potential improvements in sleep quality among individuals with spinal cord injury following respiratory resistance training.

Eligibility Criteria:
Inclusion Criteria:

* tetraplegia
* quadriplegia

Exclusion Criteria:

* NA
Guided Bone Regeneration Using Synthetic Membrane

The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have voluntarily signed the informed consent form before any study related action
* Age: 18 to 65 with missing teeth, seeking for implant therapy.
* Men/Women
* In good systemic health
* Present with no contra indication against oral surgical interventions
* Single/ multiple tooth gap - have at least one missing tooth in the mandible or maxilla, requiring one or more dental implants.
* The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation.
* Bone defect(s) must be present with a lateral dimension greater than or equal to 5 mm or less.
* Full mouth plaque score (FMPI) lower or equal than 25%
* Patients must be committed to the study

Exclusion Criteria:

* Medical conditions requiring prolonged use of steroids
* Use of Bisphosphonate intravenously
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled Diabetes
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
* Untreated inflammation
* Mucosal diseases or oral lesions
* History of local irradiation therapy
* Persistent intraoral infection
* Patients with bad oral hygiene or unmotivated for normal home care.
SMCV Assessment on Brain Swelling in Patients With SAH

Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.This study is a retrospective cohort aimed to predict the extent of brain swelling. Cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes.

Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage (SAH).This study is a retrospective cohort aimed to predict the extent of brain swelling (BS). Cerebral venous assessment can identify the risk of cerebral swelling and improve surgical outcomes. This study is a retrospective cohort analysis. Cerebral venous angiography (CVA) will be adopted and the superficial middle cerebral vein (SMCVs) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

patients with anterior communicating aneurysm

Exclusion Criteria:

Hunt-Hess grade I- patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors were excluded.
Fusion Assessment Clinical Trial

This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. This study will help researchers better understand the natural course of patients who patients who undergo spinal fusion surgery.


Eligibility Criteria:
Inclusion Criteria:

* Lumbar DDD
* Candidate for spinal fusion
* Provide written informed consent

Exclusion Criteria:

* Prior lumbar spinal fusion
* Metabolic bone disease
* Morbid obesity
* Systemic infection or active malignancy
* Pregnancy
The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients

The purpose of this study is to research the safety and efficacy of Albis® for the prevention of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.

The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients taking Low-dose Aspirin, A pilot study Double-Blind, Placebo-Controlled, Randomized, Multicenter, Parallel, Prospective study

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 20 to 80 years
* Subjects identified with at least one of the following diagnosis (Angina, Myocardial Infarction(Old), Cerebrovascular Disease, Peripheral Vascular Disease, Diabetes, Hypertension, Hypercholeseterolemia, Obesity) who are required to take a low dose of Aspirin (100mg/day) for more than 12 weeks.

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
* Peptic ulcer or Reflux oesophagitis
* hemostatic disorder or coagulation disorder
* Known allergy or hypersensitivity to the study medication
4-D Visualization Using Magnetic Resonance Imaging (MRI) in the Congenital Heart Disease Population

In this study, the investigators wish to use images obtained from standard of care cardiac MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different computer in order to analyze them with a new computer. The investigators are hoping to better their understanding and management of complex congenital heart disease.

All patients enrolled in this study will be receiving standard of care cardiac MRI as prescribed by their physician. These MRI DICOM images will be transferred to a SGI Fuel workstation, where they will be manipulated using the newly developed 4-D Visualization software. No additional scanner time or new imaging sequences are required as presently prescribed sequences and produced data can be analyzed. The workstation is designed to include acceleration hardware for volume rendering, and was developed for advanced cardiac MRI viewing.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a cardiac MRI at Children's Healthcare of Atlanta
* Informed consent
* meet MRI eligibility inclusion criteria

Exclusion Criteria:

* Not having a cardiac MRI
* No informed consent
* not meeting MRI eligibility exclusion criteria
Trauma Informed Intervention to Support Engagement in HIV Care Among MSM (THRIVE+)

This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories

The proposed intervention will incorporate the most current approaches to mediating trauma responses and stressors related to experiences of HIV stigma and homonegativity with cognitive-processing therapy, an empirically validated, cognitive-behavioral intervention for reducing negative consequences of traumatic stress. This intervention intends to improve uptake of HIV care in the prevention, engagement, and care cascade while also addressing the mental health needs of HIV-positive persons in a program of research that leads to outcomes in the short-term. If found to be efficacious, this intervention can also be scalable across clinical settings.

The study will be implemented at The Fenway Institute at Fenway Health (TFI) and at Ryerson University, Toronto, Canada and Drs. O'Cleirigh and Hart will assume the responsibility of coordinating the study across sites.

Randomization will be to the 10 session intervention or to two medication adherence/engagement in care sessions.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* is a man who has sex with men
* has a history of trauma and is experiencing trauma-related distress (as operationalized by a score of \>/= 20 on the Davidson Trauma Scale)
* is sub-optimally engaged in HIV care (as operationalized by missing 1 or more HIV care appointments in the past 12 months, having a detectable viral load at most recent testing, or having poor adherence - \</=80% - to HIV medications)

Exclusion Criteria:

* has a significant mental health diagnosis that requires immediate treatment (e.g., acute major depression; panic disorder; any psychotic disorder)
* unable to complete the informed consent process (e.g., substantial cognitive impairment, inadequate English language skills).
Coronary Spasm Presenting Aborted Sudden Cardiac Death, the Multicenter Registry

The purpose of this study is to evaluate the natural course of coronary spasm patients presenting aborted sudden cardiac death and analyze risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and more
* Coronary spasm

Exclusion Criteria:

* Life expectancy less than 2years
* Coronary stenosis 50% and more
* Structural abnormalities of the heart leading to ventricular arrhythmia