cyrilzakka/clinical-trials huggingface dataset:
Pseudotumor Cerebri Headache Ten Years Outcome

Telephone interview on patient who suffered from PTC ten years ago regarding their headache status

The study will followup using existing medical data from patients previously diagnosed with Pseudotumor cerebri (PTC) using a telephone contact with patients diagnosed more than 10 years ago. After obtaining verbal consent, conducted interviews to collect information on their headaches and quality of life. Data related to PTC was be obtained from medical records. Demographic information was be collected using a questionnaire, the HIT-6 questionnaire will assess headache severity, and a quality of life questionnaire was be used.

Eligibility Criteria:
Inclusion Criteria:

Patients who were diagnosed with PTC as children

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Exclusion Criteria:

Patients has other headache types other than PTC

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Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients

There has been an increase in incidence in sexually transmitted infections in HIV infected patients in the last years. In this study the investigators will prospectively evaluate the prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients attending the clinic for infectious diseases at the Berne University Hospital. In addition, participants will be asked to fill out a questionnaire on sexual behaviour and sexual health.

Study hypothesis: STI prevalence is high in certain risk-groups to justify screening in regular intervals.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infection
* Attending the Clinic for Infectious Diseases from May 09 to November 09
* Sexually active during the last 12 months
* Written informed consent

Exclusion Criteria:

* None
Intra-articular Glucocorticoid Treatment of the Elbow

BACKGROUND: Intra-articular glucocorticoid injections are frequently used to relieve symptoms of arthritis. Postinjection rest has been shown to improve the outcome of knee joint injections, but not for wrist injections. Consequently, different joints respond differently on postinjection regimens.

OBJECTIVES: To investigate whether better treatment results might be achieved of post-injection rest following intra-articular glucocorticoid treatment for elbow synovitis.

METHODS: 90 patients with rheumatoid arthritis (RA) and elbow synovitis were treated with 20 mg intra-articular triamcinolone hexacetonide and randomised to either a 48 hour immobilisation in a triangular sling (n=46) or normal activity without restrictions (n=44). Primary endpoint was relapse of synovitis. In addition, pain, function according to a self assessment questionnaire (PREE) and range of movement were followed for six months.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis, and
* Clinical signs of elbow synovitis

Exclusion Criteria:

* Patients in function class 4 according to Steinbrocker as well as patients with oral glucocorticoid treatment corresponding to more than 7.5 mg prednisolone or intra-articular treatment in the joint the past three months
Project Baseline Health Study

This study is the first initiative of Project Baseline, a broader effort designed to develop a well-defined reference, or "baseline," of good health as well as a rich data platform that may be used to better understand the transition from health to disease and identify additional risk factors for disease. Project Baseline endeavors to test and develop new tools and technologies to collect, organize, and activate health information.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* U.S. Resident
* Able to speak and read English
* Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

* Individuals working on Project Baseline, including the Baseline Study
* Known severe allergy to nickel or metal jewelry
A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)

The purpose of this study is to learn what happens to enlicitide chloride labeled with \[¹⁴C\] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health.
* Has a body mass index ≥18 and ≤32 kg/m\^2, inclusive.

Exclusion Criteria:

* Has a history of cancer.
* Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the safety and preliminary performance of the ROX Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. The irreversible changes to the lungs can be seen in limitations to the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX percutaneous Anastomotic Coupler System.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.

Exclusion Criteria:

* Subjects not meeting Stage III or IV Chronic Obstructive Pulmonary Disease (COPD)
* Subjects with significant comorbidities
* Subjects not qualifying because of physical or psychological condition that may put them at risk of participating
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview.

Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2).

This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.

Secondary objectives of the study are:

1. Compare the side effects of the immunosuppressive medications between both groups. This will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.
2. Compare the incidence of infections between both groups.

Comparison parameters are:

1. Pancreas and kidney graft failure
2. Patient death
3. Clinical and biopsy documented rejection episodes
4. Patient dropout (non-compliance with the study protocol)
5. Kidney function as assessed by creatinine clearance or biopsy
6. Need to change immunosuppression regimen
7. Quality-adjusted Life Years

Eligibility Criteria:
Inclusion Criteria:

1. Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.
2. Recipient age 18-60 years
3. Donor age 10-59 years
4. Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.
5. Enteric or bladder drained pancreas transplant.

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Exclusion Criteria:

1. Use of an investigational drug in the last 1-year.
2. Positive T or B cell crossmatch.
3. WBC\<3000 at enrollment
4. Platelet count \<50,000 at enrollment
5. History of malignancy (exclusive of minor skin cancers)
6. Inability to give informed consent
7. Systemic infections
8. Major active or chronic infections, including documented HIV infection (by any licensed ELISA and confirmation by Western Blot).
9. Serology negative for EBV pre-transplant.
10. No other previous organ transplants other than pancreas and/or kidney. -
A Randomized Trial of rhTPO Versus Placebo for Low/Intermediate-1 Risk MDS With Thrombocytopenia

Myelodysplastic syndrome (MDS) is a kind of clonal myeloid tumor. The major manifestation is decrease of tri-lineages of blood due to ineffective and abnormal hematopoiesis, some of which can progress to acute myeloid leukemia. According to the international prognosis scoring system (IPSS) of MDS, about 10% low/intermediate risk-1 MDS patients have severe thrombocytopenia (PLT \< 30 × 109/ L). These patients have both decreased platelet count and platelet dysfunction, resulting in a high risk of bleeding. In the new prognostic score, such as IPSS-r, the degree of thrombocytopenia is regarded as a poor prognostic factor. Platelet transfusion is mainly used in the treatment of this kind of patients. The indications of transfusion include bleeding events or severe platelet count reduction (\< 10 × 109 / L). However, platelet transfusion can only lead to short-term platelet elevation, while repeated transfusion increases the possibility of infection and ineffective platelet transfusion. TPO is a newly discovered hematopoietic promoting factor, which can specifically bind to the TPO receptor on the cell and participate in the regulation of proliferation, differentiation, maturation and division of megakaryocyte to form functional platelet. The efficacy and safety of the TPO receptor agonists eltrombopag and romiplostim in the treatment of thrombocytopenia in low/intermediate risk-1 MDS patients have been successfully confirmed in foreign studies. Recombinant human thrombopoietin (rhTPO) is also a kind of a TPO receptor agonists which is highly specific platelet stimulating factor. At present, there is no large report on the application of rhTPO in such patients. The purpose of this study is to explore the short-term and long-term therapeutic effect and safety of rhTPO on low/intermediate risk-1 MDS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed MDS, IPSS low / intermediate risk-1
2. In the 4 weeks before inclusion, the average value of platelets was ≤ 30 × 10e9 / L, or \< 50 × 10e9 / L with bleeding events
3. Patients with EPO due to anemia and G-CSF due to severe neutropenia can be included, and the dosage will not change during trial
4. Baseline liver and kidney function: ALT / ASL within 3 times normal upper limit, TBIL within 2 times normal upper limit, and creatinine within 2 times normal upper limit
5. ECOG 0-2 points
6. Able to sign informed consent

Exclusion Criteria:

1. Pregnant or lactating
2. IPSS intermediate risk-2 / high risk MDS
3. More than 5% of myeloblasts in bone marrow
4. Myelofibrosis
5. Previous transplantation or ATG treatment within 6 months
6. Previous use of IL-11, TPO or other TPO receptor agonists
7. Active infection or tumor
8. Thromboembolic or hemorrhagic disease
9. Serious heart disease, including unstable angina, congestive heart failure, arrhythmia, 1-year history of myocardial infarction
10. Intracranial hemorrhage within 4 weeks
A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases

This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.

This is a phase 2, multicenter, open-label study to evaluate of the efficacy and safety of SGB-9768 in patients with primary IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. The primary objective is to evaluate efficacy of SGB-9768 in reducing urine protein excretion and maintain kidney function in these patients. Secondly, safety, pharmacokinetics and pharmacodynamics will be charaterized.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Weight ≥40 kg, with a body mass index (BMI) between 15 and 35 kg/m²
* Biopsy-confirmed diagnosis of primary IgA nephropathy, C3 glomerulopathy or IC-MPGN, accompanied by C3 deposition in the glomeruli.
* Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g
* Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) must be ≥30 mL/min/1.73 m².
* Must be on a stable maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks
* Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug

Exclusion Criteria:

* Kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis.
* Kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis.
* IgA nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases
* Presence of other systemic diseases or kidney diseases that may cause proteinuria
* Received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug
* Received B-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug
* Used SGLT2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more
* Significant comorbidities
* History of any malignant tumors of any organ system within the past 5 years
* History of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study.
* History of immunodeficiency diseases, congenital asplenia or splenectomy.
* History of recurrent invasive infections, active systemic bacterial, viral, or fungal infections
* Positive test results for HBV, HCV, HIV
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 2.5 times the upper limit of normal (ULN)
Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy

The purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thyroidectomy,
* Age 20-65,
* American Society of Anesthesiologists physical status classification I or II.

Exclusion Criteria:

* History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs,
* History of drug \& alcohol abuse,
* Psychiatric disorder,
* Use of opioids within 24hrs,
* Renal disease with decreased GFR,
* Neuromuscular disease, Severe cardiac disease.
Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers

A formal randomized efficacy trial testing the Mothers and Toddlers' program, an attachment-based parenting intervention for mothers enrolled in addiction treatment and caring for young children.

Five years ago the investigators were funded to develop the Mothers and Toddlers Program (MTP; R01 DA17294 / Project Period: 8/20/04 - 12/31/09). MTP is the first parenting intervention developed for substance abusing mothers based on the attachment theory. It is also the only parenting intervention for substance abusing mothers that has led to improvement in maternal caregiving sensitivity and responsiveness to infant and toddler distress in observed lab-based interactions. The investigators now have all the research materials to conduct a Stage II randomized clinical trial including a treatment manual, treatment fidelity scales therapist training program and outcome measures. In this Stage II formal efficacy trial, the investigators (1) Introduce new measures of dyadic adjustment and child attachment, (2) Add an 18 week follow up period to test for sustained treatment effects, (3) Measure major constructs (reflective functioning, representations, dyadic adjustment, and child attachment) when they are expected to change, (4) Examine temporal mechanisms of change proposed in the MTP treatment model (5) Determine whether improvements in dyadic adjustment reduces incidence of relapse, (6) Broaden the MTP therapist pool by training four new therapists and (7) Broaden the coding pool by training 3 additional coders per measure. One hundred and fifty mothers caring for children ages 12 to 60 months of age will be recruited from outpatient substance abuse treatment services at the APT Foundation into the intention-to-treat sample and will be randomized to 12 weeks of MTP vs. PEP and followed for 33 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All mothers ages 21 to 45 years, who are enrolled in treatment at one of the five APT Foundation clinics and caring for a biological child between 12 and 60 months of age will be eligible to participate.

Exclusion Criteria:

* Severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
* Severe cognitive impairment
* Inability to speak English
* Target child with serious illness or significant developmental delay (e.g., cognitive, language, or motor).
PORH and Response to Cold in Raynaud's Phenomenon.

The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.

The main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.

Healthy controls and patients will undergo 3 visits

Eligibility Criteria:
Inclusion Criteria:

* Neither raynaud's phenomenon or chronic disease for healthy volunteers
* Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"

Exclusion Criteria:

* History of axillary dissection , trauma or surgery
* History of thromboembolic disease or thrombophilia
* Minor or law-protected major
* Exclusion period in another study
* No affiliation to medicare
* Pregnant, parturient or breasting woman
* Concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor
* Smoking in the 6 last months
* Person deprived of liberty by a legal or administrative decision, person under legal protection
* Maximal annual indemnification reached.
Accelerometer Sensing for Micra AV Study

The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.

The Accel AV study is a prospective, single-arm, global, multi-center clinical study to characterize the chronic AV synchrony in subjects implanted with the market released Micra AV system. The study is planned to be conducted in the US and Hong Kong. Overall, the study is expected to be conducted at approximately 20 centers.The expected total study duration is approximately 12-15 months, representing the time necessary to enroll the target sample size and to complete the 3-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication.

* Subject has history of AV block.
* Subject is ≥ 18 years old and as per required local law.
* Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
* Subject is willing and able to comply with the protocol.

Exclusion Criteria:

* Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist.
* Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIED infection).
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implant procedures).
* Subject meets any exclusion criteria required by local law (age or other).
Pirfenidone and Its Role in Burn Wound Healing

Burn patients which skin has been lost a rapid growth of the skin is a foremost in their treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the skin heal faster. However, several studies have shown that this inflammation increases the levels of several inflammatory molecules that impairs skin growing, which further delays the recovery of burn patients. As such, by inhibiting these inflammatory molecules with the administration of a medication called pirfenidone burn patients might present faster rates of skin growth and recovery. Thus, patients suffering from a burn injury will be recruited at the emergency department of the Hospital University in Monterrey Mexico. Afterward, patients will be randomized to either receive pirfenidone 600 mg orally once per day or usual care consisting of covering the wound with hydrocolloid dressings. To assess the amount of newly growth skin investigators will take a small piece of the skin to further evaluate it through a microscope.


Eligibility Criteria:
Inclusion Criteria:

* Patients with second-degree burns from any etiology with less than 24 hours of evolution.

Exclusion Criteria:

* Patients \<18 years old
* Patients allergic to pirfenidone
* Pregnant patients
* Patients with renal or hepatic failure
* Patients who are not able to take the medication orally
* Conditions or drugs that alter wound healing (i.e. any kind of diabetes, lupus, having a history of using steroids, rheumatoid arthritis)