cyrilzakka/clinical-trials huggingface dataset:
Limb Girdle Muscular Dystrophy (LGMD) Natural History

The purpose of this study is to understand more about limb-girdle muscular dystrophy. Therefore, the investigators would like to track the following information collected once a year from patients with GENETICALLY CONFIRMED LGMD: quality of life questionnaires, muscle strength, motor function, routine examination, assessment of patient (or parent) understanding of LGMD, and serum (blood) for growth factors, cytokines, and biomarkers (all parts of your blood). By tracking this information, we hope to be able to understand more about the diagnosis, progression and natural history of this disorder.


Eligibility Criteria:
Inclusion Criteria:

* You have a GENETICALLY CONFIRMED diagnosis of Limb Girdle Muscular Dystrophy
* You must be at least 6 years of age or older (if under 18 you will need Parental consent)
* You must be able to travel to the study site
* You must be able to provide a DNA/Gene testing report that confirms a diagnosis of LGMD

Exclusion Criteria:

* You or your child do not have a diagnosis of LGMD
* Your child is under age 6
* You or your child are not able to travel to the study site
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
* Patient is 18 to 80 years of age at the time of consent (inclusive).
* Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC.
* Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
* Patient's esophagectomy is clinically necessary due to reasons unrelated to this study.
* Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

* Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
* Patient refuses or is unable to provide written informed consent. - -
* Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
* Patient has esophageal narrowing limiting access to the intended site of ablation.
* Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
* Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).
Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin

Percutaneous liver biopsy (PLB) is the gold standard for grading necroinflammation and staging fibrosis in patients with chronic viral hepatitis. Whether the use of 1-deamino-8-D-arginine vasopressin (DDAVP) before PLBs in hemodialysis (HD) patients with chronic viral hepatitis has comparable safety profiles to those with normal renal function (NRF) has not been evaluated in prospective studies.

Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. Currently, percutaneous liver biopsy (PLB) remains the gold standard for grading necroinflammation and staging fibrosis in patients with liver diseases. In addition, liver histology can help clinicians determine the eligibility of renal transplantation, prognosis, and necessity of antiviral therapy in dialysis patients with chronic viral hepatitis. In chronic hepatitis patients with normal renal function (NRF), the risks of fatal and non-fatal hemorrhage after liver biopsies for non-malignant diseases were 0.04% and 0.16%, respectively. However, the relative risks of post-biopsy hemorrhage in CHC patients with end-stage renal disease to those with NRF remain disputed.

Deamino-8-D-arginine vasopressin (DDAVP), a synthetic analogue of vasopressin, is a commonly used hemostatic agent to treat uremic bleeding by inducing the release of von Willebrand factor (vWF) and factor VIII from their storage sites in endothelial cells.Previous studies have shown that one dose of 0.3-0.4μg/kg body weight DDAVP infusion for dialysis patients could normalize bleeding time (BT), and prevent surgical and renal biopsy bleeding. Nevertheless, two recent studies showed divergent liver biopsy-related bleeding complication rates (0% and 6%, respectively) in dialysis CHC patients pre-treated with DDAVP. Since most studies evaluating the safety of PLB in CHC patients with dialysis were small and retrospective in nature, and not controlled by the biopsy route, the type of biopsy needle, the use of ultrasound guidance, or the number of passes,further studies are urgently needed to solve this important issue. Thus, we aimed to conducted a large clinical trial to compare the safety profiles of PLB between CHC patients with hemodialysis (HD) who were pretreated with DDAVP and those with NRF by the same biopsy technique.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C (presence of anti-HCV and serum HCV RNA \> 6 months)
* Chronic hepatitis B (presence of HBsAg \> 6 months)
* Receiving regular hemodialysis or normal renal function (Creatinine \< 1.5 x ULN)
* Receiving percutaneous liver biopsy (PLB)

Exclusion Criteria:

* Human immunodeficiency virus (HIV) co-infection
* Unwilling or contraindicated to receive percutaneous liver biopsy (PLB)
* Receiving liver biopsy without ultrasound (US) guidance or automatic cutting needles
* Did not receive 2 passes of liver biopsy
* Inadequate record of post-biopsy complications
Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome

This study evaluates the immediate and short-term effects of a supine upper thoracic spine thrust manipulation, seated upper thoracic spine thrust manipulation, and sham manipulation for individuals with subacromial pain syndrome. The participants were randomized to receive one of the three interventions and baseline measures for the dependent variables were repeated immediately after the delivery of the intervention.

Thoracic spine thrust manipulation has been shown to be effective in reducing pain and improving function in individuals with subacromial pain syndrome (subacromial impingement). It remains unknown if individuals respond differently to different manipulation techniques. This study examines the immediate effects on pain and short-term effects on pain and function using the Penn Shoulder Score (PSS) as well as the immediate effects on scapular kinematics (upward rotation and posterior tilt, specifically), pectoralis minor muscle length, and scapulothoracic muscle force production for the middle trapezius, lower trapezius, and serratus anterior.

Eligibility Criteria:
Inclusion Criteria:

* currently experiencing shoulder pain for less than 6 months
* at least 3 of the following findings: 1) pain localized to the proximal anterolateral shoulder region, 2) positive Neer or Hawkins-Kennedy impingement test, 3) pain with active shoulder elevation (which may include a painful arc), 4) active shoulder abduction ROM of at least 90°, 5) passive shoulder external rotation ROM of at least 45°, and 6) pain with isometric resisted abduction or external rotation

Exclusion Criteria:

* signs of a complete rotator cuff tear
* significant loss of glenohumeral motion
* acute inflammation
* cervical spine-related symptoms including a primary complaint of neck pain, signs of central nervous system or cervical nerve root involvement, or reproduction of shoulder or arm pain with cervical rotation, axial compression, or Spurling test
* previous neck or shoulder surgery
* positive apprehension test or relocation test
* history of shoulder fracture or dislocation
* history of nerve injury affecting upper extremity function
* any contraindication for thrust manipulation to the thoracic spine including osteoporosis, fracture, malignancy, systemic arthritis, or infection
* fear or unwillingness to undergo thoracic spine manipulation
A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia

This is a 2-phase study during which patients with select myeloid leukemias or advanced myelodysplastic syndrome (MDS), who have failed, refused or are not eligible for standard treatment, will receive investigational study drug ARRY-520.

The study has 3 parts. The first phase of the study, Phase 1, has 2 parts. In the first part of Phase 1, patients with select myeloid leukemias or advanced MDS will receive increasing doses of study drug on different schedules in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients (per schedule) from the US will be enrolled in Part 1 (Completed). In the second part of Phase 1, patients with advanced MDS will receive the best dose of study drug and schedule determined from the first part of the study. Approximately 10 patients from the US will be enrolled in Part 2 (Completed).

In the third part of the study, Phase 2, patients with acute myeloid leukemia (AML) or advanced MDS will receive the best dose of study drug and schedule determined from the first part of the study and will be followed to see what side effects the study drug causes and to see what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).


Eligibility Criteria:
Key Inclusion Criteria (Part 2):

* Patients with either Intermediate-2 or High risk MDS or with AML (\>20% bone marrow blasts) with stable low or normal white blood cell count (WBC). Patients should have failed one prior chemotherapy regimen which should have included a hypomethylating agent.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Discontinuation of prior treatment at least 2 weeks prior to the start of the study.
* Adequate hepatic and renal function.
* Additional criteria exist.

Key Exclusion Criteria (Part 2):

* Concurrent cytotoxic therapy, or biological, endocrine and immunological response modifiers.
* Previous radiation to \>25% of bone marrow.
* Other active malignancies.
* Known positive serology for the human immunodeficiency virus (HIV).
* Central nervous system involvement as documented by spinal fluid cytology.
* Active, uncontrolled infection.
* Additional criteria exist
Viral and Host Factors in the Transmission and Pathogenesis of HIV

To study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.

The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines.

This phlebotomy protocol permits the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.

Participants will have from 10 to 60 ml (approximately 1 to 4 tablespoons) of blood drawn for one or all of the following tests:

* T cell subset enumeration
* Serologic reactivity with HIV antigens
* Viral load assays by bDNA, PCR, or RT-PCR
* Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
* HIV-1 Resistance Testing

These data are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines

Eligibility Criteria:
Inclusion Criteria:

recently infected with HIV-1 HIV-1 negative, and at high risk for infection

Exclusion Criteria:

none
Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.

This study is a randomized, open-label, 2-period, 3-treatment, 1-sequence, drug-drug interaction study in healthy volunteers to evaluate effect of ketoconazole or rifampicin on the PK characteristic and safety of LC15-0444.

Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks(-28 d \~ -2 d) before the first drug administration(1 d). Eligible subjects will be randomized to one of study treatment groups.

According to the characteristics of anti-diabetic drugs, it is expected to be administered with other drugs in many patients. Therefore, Drug-Drug Interaction with CYP3A4 inducer and inhibitor should be identified in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Is a healthy male between 20 and 50 years old
* Has BMI result between 19 and 26 kg/m2 at screening; and a total body weight over 55 kg. BMI(kg/m2) = body weight(kg)/{height(m)}2.
* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Agrees to use an adequate means of contraception during clinical trials

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hepatic, renal, digestive, neurologic, pulmonary, musculoskeletal, endocrine, hematological, cardiovascular or psychiatric disease
* Subjects with evidence or history of gastrointestinal disease or surgery possibly affecting drug absorption.
* Subjects with history of hypersensitivities or clinically significant adverse events caused by DPPIV inhibitors, ketoconazole, rifampicin, and other drugs
* Subjects who have donated a unit of blood within 60 days or blood components within 30 days before the first administration of the investigational product.
* Subjects who consume excessive alcohol or caffeine; who excessively smoke
Effectiveness of Immersive Virtual Reality in Functional Rehabilitation in Older People With Knee Arthroplasty

The number of knee arthroplasties performed each year is constantly increasing. Although the outcome is generally favourable, 10-20% do not achieve a satisfactory clinical result. This study evaluates the effectiveness of immersive virtual reality rehabilitation in older people who have undergone knee arthroplasty surgery. The 6 Meter Walking Test is used to determine the improvement of patients after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* people who are admitted to one of the two chosen residences on the Costa del Sol who have had, or will have, a total knee arthroplasty recently.
* People between 60-75, who want to receive rehabilitation treatment.

Exclusion Criteria:

* Patients who refuse to participate or who suffer serious post-operative complications.
* patients with neurological or cognitive impairment that could interfere with the performance of the rehabilitative treatment will be excluded.
* Those with any severe cardiovascular or pulmonary disease that would prevent them from exercising and also those who are not allowed physical activity for any reason.
* Those with poor visual acuity who are unable to see the visual characteristics of the screen.
* Patients with severe contralateral knee osteoarthritis (\>5/10 pain when climbing stairs) or other orthopaedic conditions that limited function and required an alternative simultaneous operation, e.g. severe lumbar spinal stenosis, severe OA of the hip or ankle...
* Those who are scheduled for other lower limb surgery in the next 6 months.
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.

Exclusion Criteria:

* Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through

This is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. Several, mainly European, centres which perform G-POEM on a routine basis will be asked to participate. The main reason to assess the effectiveness of G-POEM in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of G-POEM.

The participating centres will be asked to report appropriate patients among those who have undergone G-POEM since 2015 till December 2023. Patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after G-POEM. The main outcome is the symptomatic response at 6, 12 and 24 months (measured by GCSI score). Other endpoints will be change in other symptoms not covered by GCSI, change in gastric emptying rate and safety of the procedure.

For each enrolled patient a case report form (CRF) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. The leading centre will be responsible for data collection and analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent G-POEM after esophagectomy with a gastric pull-through for confirmed (scintigraphy or breath test) or presumed gastroparesis. (Some centres perform G-POEM in patients whose gastroparesis was not confirmed by a scintigraphy or a breath test, therefore it is only presumed. This particular subset of patients will be analysed separately.)
* Total GCSI score before G-POEM at least 1.0.
* At least 6 months follow-up after G-POEM.

Exclusion Criteria:

* Organic pyloric obstruction
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* On a stable dose of metformin as defined by the protocol
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
The Efficacy of Nifedipine in the Management of Preterm Labor

Preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. The incidence of preterm birth is around 7 to 9 %. The preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. The correct diagnosis should be followed by the early administration of the most effective tocolytic agent with least side effects for both mother and fetus. Nifedipine, a calcium channel blocker, has gained a world-wide popularity recently since it has the least side-effects on both mother and fetus. In the present study, we aimed to evaluate the success rate of tocolytic agent 'nifedipine' on the spontaneous preterm labor of singeton pregnant women with intact amnionic membrane.

Preterm birth is the main reason of perinatal morbidity and mortality. The main management method of this important problem is to prolong the pregnancy period and to use corticosteroids to prevent fetal pulmonary distress. The most widely studied tocolytic agents, ritodrin, salbutamol and terbutaline are all betamimetics, and they are shown to prolong birth labor till 7 days and do not have any effct on the fetal mortality. However, their maternal side-effects are inevitable and can be mortal. They cause tachycardia, hypotension and some biochemical disturbances. Furthermore, maternal death is possible due to pulmonary edema. These adrenergic agonists are the first line tocolytics, but calcium canal blockers are becoming more popular since they have less side effects and comparable efficacy.

Calcium canal blockers are nonspecific smooth muscle relaxants used in adult hypertension treatment. Their tocolytic effect depends on their inhibition of calcium ions into the myometrial cells. In vitro studies have shown that they have strong relaxant effects on human myometrium. In the present study, our aim is to investigate the effects of nifedipine in our clinic in a period between 2002 and 2005, when it was first used in our clinic as the sıngle tocolytic agent. Its success in preventing preterm labor and its complications in our earlier practice will be noted and this retrospective study will guide us in its current usage, dosages and side-effects.

Eligibility Criteria:
Inclusion Criteria:

* ingleton pregnant women with spontaneous preterm labor at their 23-37 weeks.

Exclusion Criteria:

* Normal pregnant women
* Pregnent women before 23 weeks of gestation
* Pregant women between 23 and 37 weeks of gestation, but with preterm early membrane rupture, chorioamnionitis, preterm labor without cervical change, multiple pregnancy, hypertension, intrauterine growth retardation, fetal anomaly, oligoanhidramniosis, placenta previa, decolman placentaand intrauterine fetal death
Integrating Interventions for Maternal Substance Abuse

This Research Plan proposes Stage 1 Research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. Mothers with a history of methamphetamine abuse and child neglect will be recruited. Using an intensive community based treatment, mothers will receive substance abuse treatment combined with parenting skills training and psychosocial support for basic needs (e.g., housing, employment). This project will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to treatment as usual, with a population of substance abusing neglectful mothers referred through the Department of Child Welfare.


Eligibility Criteria:
Inclusion Criteria:

* Maternal Substance Abuse
* Child Welfare involvement
* Child Neglect
* English Speaking
* Child either remaining in the home or reunification plan in place
* Living in the county

Exclusion Criteria:

* Current involvement in other substance abuse treatment
* Current involvement in other parenting skills training
* parental rights terminated
* active psychosis