cyrilzakka/clinical-trials huggingface dataset:
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan

This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.

This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. It will be conducted in close collaboration with the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie Stopes Society clinics that have experience with implants and sufficient expected flow of implant users per month. We will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrolment; and
* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Femplant services.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for inclusion, a woman must:

  * be aged 18-44 years, inclusive
  * be willing to sign an informed consent document
  * agree to return for follow-up visits
  * have decided to receive Femplant as a method of contraception and met the clinic criteria for eligibility of this method of contraception
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients
* Presumed diagnosis of GERD
* Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks

Exclusion Criteria:

* cardiovascular instability
* clinically significant laboratory abnormalities
* use of warfarin, carbamazepine, phenytoin, or rifampin
Acute Kidney Injury After Cardiac Arrest

The development of AKI (Acute Kidney Injury) after cardiac arrest is a common factor associated with mortality. In this study, we aimed to evaluate the factors that increase the risk of developing AKI after cardiac arrest.

For the study, patients were evaluated for the incidence of acute kidney injury (AKI), factors that increase the risk of AKI, and the impact of AKI on mortality. In this process, demographic data, comorbidities, hemodynamic data, laboratory data, clinical symptoms and findings recorded in the electronic decision support system were recorded and analyzed.

This retrospective study was performed on patients hospitalized in intensive care units after cardiac arrest between 2013 and 2022. Patients who met the inclusion criteria were included in the study. Urea, creatinine values, and whether AKI was diagnosed or not were obtained from the data registry system. Statistical evaluation was performed using univariate binary logistic regression analysis.

Demographic data, location of cardiac arrest (in-hospital, out-of-hospital), and duration of CPR were recorded. In addition, the causes of cardiac arrest, HR/MAP (heart rate/average arterial pressure) ratio, and whether VSP (vasopressor) or INO (inotropic) medication was needed were recorded.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with spontaneous circulation after cardiac arrest and admitted to the intensive care unit

Exclusion Criteria:

* Deaths in the first 48 hours
* Missing data
* End stage CKD or first day hemadsorption
* CPR time \<3 min
* Unwitnessed cardiac arrest
* Terminal malignancy

  * 90 years old
* Having a pace marker
* Massive bleeding
* ECMO application
* First day diyabetes insipitus
High Flow Nasal Cannula in Patients Undergoing Gastroscopy

During gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce modifications to respiratory mechanics, respiratory effort and breathing pattern.

High-flow nasal cannula (HFNC) therapy is a mixed air-oxygen supply system able to deliver heated humidified gas up to 60 L/min of flow rate, with an inspiratory oxygen fraction (FiO2) ranging from 21% to 100%. Increasing evidence supports the use of HFNC in several clinical conditions and settings. When compared to standard therapy (ST), HFNC results in enhanced gas exchange and improved comfort.

No studies have yet assessed the benefits of HFNC versus ST during and after gastroscopy. We designed this unblinded randomized controlled trial to assess whether HFNC, compared to ST, improves oxygenation at the end of the procedure (primary endpoint). Additional endpoints were: 1) the lowest peripheral saturation of oxygen (SpO2) and the number of oxygen desaturations; 2) the changes of end-expiratory lung impedance and tidal impedance assessed by Electrical Impedance Tomography (EIT); 3) the effects on diaphragm function assessed by ultrasound (DUS).


Eligibility Criteria:
Inclusion Criteria:

* outpatients with the indication to diagnostic gastroscopy

Exclusion Criteria:

* life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
* need for invasive or non invasive ventilation
* presence of pneumothorax or pulmonary enphisema or bullae
* recent (within 1 week) thoracic surgery
* presence of chest burns
* presence of tracheostomy
* pregnancy
* nasal or nasopharyngeal diseases
* dementia
* lack of consent or its withdrawal
Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma

This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin, in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in combination with rituximab in patients with NHLs. This is the first study combining the two agents together. In the present study Inotuzumab Ozogamicin will be administered intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated every 28 days.


Eligibility Criteria:
Key inclusion criteria

* Histologically and/or cytologically confirmed relapsed or refractory CD22+ B-cell Non Hodgkin's Lymphomas
* No limitations on prior treatments. Patients must have progressed after at least one prior therapy.
* Adult patients (aged \> 18yrs old).
* ECOG status ≤ 1.
* Life expectancy greater than 3 months.
* Adequate organ and marrow function.

Key exclusion criteria

* Uncontrolled intercurrent illness
* Chronic obstructive or chronic restrictive pulmonary disease
* Hepatitis B, C and HIV
* Patients with known known central nervous system lymphoma involvement.
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* History of gout
* at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
* Patients who are NOT on approved ULT must have sUA \> 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* Pregnant or breastfeeding
* History of kidney stones
Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)

Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.

Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.

The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 years or more
* Hemiplegia secondary to stroke
* Interval between stroke and study inclusion of 4 month or less
* First supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke
* Non ambulatory patient (Functional Ambulatory Category Stage 0 or 1)
* Being able to sit unsupported at the edge of the bed
* No severe impairment of cognition or communication
* Written informed consent

Exclusion Criteria:

* Orthopedic and/or rheumatological disease impairing mobility
* Other Neurological associated disease
* History of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion
* Chronic pulmonary disease
* Intolerance to stand up
Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care

To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions.

The combined immune cell therapy has a strong potential to improve treatment outcomes in several cancers, but problems related to manufacturing complexity, immunocompatibility, and poteintial toxicity may also arise. This clinical study was designed to address these challenges and to establish the safety and potential efficacy of combined immune cell therapy for unresectable colorectal cancer. This is a phase I study to evaluate the safety and potential efficacy of combined immune cell theapy, and obtain the recommended dose and infusion plan.

Eligibility Criteria:
Inclusion Criteria:

* Those who have been histologically or cytologically confirmed as adenocarcinoma among colorectal cancers
* Those with at least one measurable or evaliable lesion by RECIST v1.1
* Those who fail standard treatment for metastatic colorectal cancer (failure of treatment is defined as failure of not only progression of the disease or recurrence after treatment, but also unacceptable side effects or maintenance of the treatment process)
* ECOG performance status 0 or 1 person
* A person who can draw about 100 cc of whole blood for the manufacture of immune cells

  * Weight: More than 50 kg for men and more than 45 kg for women
  * Hb: 9.0 g/dL or higher (registerable if hemoglobin levels recover to 10.0 g/dL or higher during the screening period); however, transfusions within 7 days prior to screening to meet this standard are not allowed)
* Appropriate contraceptive regimen up to 2 months after clinical research drug administration
* A person who voluntarily decides to participate after receiving a sufficient explanation for this clinical study and agrees in writing

Exclusion Criteria:

* Brain Metastasis patients who have symptoms or need treatment \[However, patients with stable brain metastasis who have no symptoms and do not need treatment (excluding anticonvulsants in maintenance therapy) can register\]
* A person with a systemic disease that is inappropriate to administer anticancer drugs according to the researcher's judgment
* Those with the following cardio-cerebrovascular diseases as of the time of screening
* a person who is HIV-positive
* Those determined that the researcher was not suitable for participation in this clinical study as a result of the active infection (HBV, HCV) test
* a person with acute or severe infection
* Those who have autoimmune diseases or have a history of chronic or recurrent autoimmune diseases
* Those with a history of organ transplants
* a hematopoietic stem cell transplant patient
Clinical Outcome After Treatment of Patellar Fractures With Locking Plates

Depending on the fracture pattern of patellar fractures tension band wiring, interfragmentary screw fixation or combinations are common treatments. But there are several problems associated with these techniques as fracture dislocation or loosening and perforation of the wire. Furthermore an anatomic reduction with stable fixation in comminuted fractures is almost impossible to achieve.

A new option in the treatment of patellar fractures is the locking plate osteosynthesis, which provides a more stable fixation and higher mechanical strength in biomechanical tests compared to classic tension band wiring. Due to various screw positioning a stable fixation in comminuted fractures can be achieved and an early functional treatment with full weight bearing reduces the loss of knee-motion. Furthermore a removal of the osteosynthesis seems not to be essential anymore and the blood supply is not to be compromised.

Because of the absent of clinical evidence investigators want to evaluate the clinical outcome after locking plate osteosyntheses in patellar fractures and compare patient satisfaction, functional motion, complications and number of revisions with common treatments.


Eligibility Criteria:
Inclusion Criteria:

* patients with indication for operative treatment of a patellar fracture
* sufficient compliance
* signed patient information

Exclusion Criteria:

* preoperative disease or trauma of the patellar
* preoperative loss of motion of the knee
* former operations of the patellar
* alcohol or drug consumption
Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

Osteo introducer system is the instruments used in minimal invasive THA. This study will compare the minimal invasive THA using the osteo introducer system and THA using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of THA surgery.


Eligibility Criteria:
Inclusion Criteria:

* With indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.)
* BMI\<30
* Subject is a candidate for primary total hip arthroplasty
* No obvious congenital abnormality in hip joint
* Subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
* Overt infection
* Distant foci of infections
* Allergy to metals
* Rapid disease progression as manifested by joint destruction or bone absorption apparent on X-ray
* Skeletally immature
* Neuropathic joints
* Hepatitis or HIV infection
* Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
* Pregnant or lactating women
* Subjects enrolled in another drug or device clinical investigation within 3 month
* Investigator has judged the subject is not suitable for the study
Electronic Mobile Phone App Stool Diary

Our objective here is to improve the patient's compliance and accurate capture of patient reported bowel and abdominal symptoms, by utilizing a phone application that interactively records each bowel movement or leakage event and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. We will compare and validate the electronic stool diary with the paper stool diary.

Fecal incontinence consists of multiple and often unpredictable bowel movements and leakage of stool. Chronic constipation is associated with episodes of irregular and unpredictable bowel habits and difficulty with remembering symptoms. These features lead to a recall bias, and inaccurate recollection and/or documentation of symptoms that are critical for diagnosis and management. A daily stool diary has been used in clinical trials and in clinical practice to accurately record bowel symptoms. However, patients find these diary entries cumbersome or embarrassing to use, especially with bowel movements that occur outside of home resulting in loss of data or inaccurate collection of information. Also, many patients forget events especially when this bowel habit is irregular. Therefore, it is crucial to explore new ways of accurately, reliability, and more discretely collect bowel habit information, by using current technology that a majority of people have access to.

Eligibility Criteria:
Inclusion Criteria:

* Anyone older than 18 years with symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).
* Women of childbearing age will be asked if they are pregnant, and a confirmed negative response is given will be sufficient. No pregnancy test will be performed.

Exclusion Criteria:

* None
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have chronic renal insufficiency (pre-dialysis)
* Have below normal creatinine clearance
* Have elevated parathyroid hormone levels

Exclusion Criteria:

* Pregnant or nursing
* Heart attack in the last 3 months.
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

The study may enroll approximately 45 subjects in total.

Eligibility Criteria:
Inclusion Criteria (abbreviated):

1. Age ≥18 years.
2. Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Adequate renal, liver, cardiac, and pulmonary organ function.
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.

Exclusion Criteria (abbreviated):

1. Prior allogeneic stem cell transplant (SCT).
2. Prior treatment with any anti-CD70 targeting agents.
3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
4. Active HIV, hepatitis B virus or hepatitis C virus infection.
5. Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for \>12 months, or any other localized malignancy with low risk of developing into metastatic disease.
6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
7. Prior solid organ transplantation.
8. Pregnant or breastfeeding females.
Optimizing Veteran-Centered Prostate Cancer Survivorship Care

This study will provide much needed information about how to optimize the quality of care and quality of life of Veterans who are survivors of prostate cancer.

Although there are nearly 150,000 prostate cancer survivors in the VA, there has been little research to understand and improve survivorship care for this large population of Veterans. A substantial proportion of prostate cancer survivors in the general population have significant side effects from treatment (surgery or radiation therapy) that often persist for years, including incontinence, erectile dysfunction, and metabolic syndrome, all of which can contribute to decreased quality of life. The investigators' pilot data suggests that VA prostate cancer survivors experience similar or worse symptom burden to that of the general population of survivors. To address the need to improve patient-centered survivorship care management for Veterans with prostate cancer, the investigators propose a 4 year study with two aims: 1) to conduct a randomized controlled trial to compare a personally tailored automated telephone symptom management intervention for improving symptoms and symptom self-management to usual care. The investigators expect that those in the intervention group will have more confidence in symptom self-management and better symptom self-management and prostate cancer quality of life following the intervention, and that these outcomes will translate to more efficient use of services for these Veterans, and 2) to compare utilization of services among those in the intervention group to those in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Veteran patient at one of the four study sites (Ann Arbor VA, Cleveland VA, Pittsburgh VA, St. Louis VA)
* History of treatment for prostate cancer treated by surgery, radiation or androgen deprivation therapy between 1-10 years prior to identification

Exclusion Criteria:

* No phone number on file
* Not able to converse on the telephone in English
* Treated for metastatic disease or non-prostate cancer
* Dementia or other significant mental impairment
Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.

The research plan is conceived in two sections, as follows. (i)The technical study handles the set-up, motion and dosimetric issues of the radioablation technique using CyberKnife system.

(ii)The clinical section is organized in two studies: a phase I dose escalation study to identify the maximum tolerated dose (MTD) delivering 18 Gy, 21 Gy and 24 Gy in single fraction and a phase II study to evaluate the rate of pathological complete response (pCR) when a dose level is chosen according to the results of the previous phase I study.

Study population includes patients affected by cT1-T2 (up to 2.5 cm) cN0, adenocarcinoma of the breast, diagnosed with conventional workup. Surgical tumor removal will be scheduled after 4-8 weeks after radioablation. Whole breast radiation therapy without boost will be performed after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven unifocal adenocarcinoma
* T1-T2
* Tumor size up to 2.5 cm
* cN0
* Age ≥ 18 years old
* Good general condition (ECOG 0-2)
* Planned BCS
* Written informed consent

Exclusion Criteria:

* Tumor close to skin or chest wall
* Pure non-invasive tumor
* Prior RT to the chest
* Neoadjuvant chemotherapy
* Collagenopathies
* Coagulation or autoimmunitary disorders
* Previous malignancies