cyrilzakka/clinical-trials huggingface dataset:
Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to help raise red blood cell levels without blood transfusions.

* Participants will receive Darbepoetin alfa through an injection under the skin, about 28-35 days after their allogeneic stem cell transplant. They will continue to receive the study drug once every three weeks for a maximum of four doses.
* Blood tests will be performed at weeks 3, 6, 9 and 12. The blood tests done at week three will check to make sure the participant has enough iron in their system. If not, they will need to take an iron supplement. Participants will also take a folate supplement to help cell growth and reproduction.

Eligibility Criteria:
Inclusion Criteria:

* Hematologic malignancies undergoing ablative allogeneic stem cell transplantation for any indication
* 18 years of age or older
* Hgb of less than 10 g/dL at the time of initiation therapy

Exclusion Criteria:

* Known hypersensitivity reaction to darbepoetin alfa or any of its components
* Transfusion of packed red blood cells within 3 days of initiation of treatment with darbepoetin alfa
* Any history of grade III or IV GVHD
* Use of any erythropoietic growth factor since transplantation
* Uncontrolled hypertension
* History of seizure
* Baseline creatinine greater than 2
* Dialysis dependence at the time of enrollment
* Hemolytic uremic syndrome
* Active GI bleeding
* Concurrent autoimmune hemolytic anemia
* Concurrent unstable angina
* History of congenital hypercoagulable state or previous venous or arterial thrombosis
* Relapsed disease prior to the initiation of study treatment
* History of renal cell carcinoma
Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil.

The study was carried out within a large, urban prospective cohort of PLHIV at the Instituto Nacional de Infectologia Evandro Chagas (INI). Located in Rio de Janeiro, Brazil, INI is a national public referral center for PLWHA receiving primary care since 1998. From December 2019, adults who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy were enrolled by active site searching


Eligibility Criteria:
Inclusion Criteria:

* individuals were deemed as regular smokers, defined as the consumption of one or more pack (20 cigarettes) per week in the past 6 months, and expired carbon monoxide (CO) measurement \> 10 ppm at the screening visit.

Exclusion Criteria:

* previous use of transdermal nicotine patches or bupropion in the last 6 months; (ii) contraindication to nicotine patches; (iii). Pregnancy; (iv) breastfeeding
A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.

The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction
* older than 20 years old

Exclusion Criteria:

* Operable case
* Non-hilar biliary malignant obstruction
* Duodenal obstruction
* Other cancer except biliary malignancy
* uncontrolled infection status
* Eastern Cooperative Oncology Group ≥ 3
* No signed informed consent
* Failed endoscopic approach to duodenum or biliary tract
Artificial Intelligence System for the Detection and Prediction of Kidney Diseases Using Ocular Information

This is an retrospective and prospective multicenter study to develop and validate an artificial intelligent (AI) aided diagnosis, therapeutic effect assessment model including chronic kidney disease (CKD) and dialysis patients starting from April 2009, which is based on ophthalmic examinations (e.g. retinal fundus photography, slit-lamp images, OCTA, etc.) and CKD diagnostic and therapeutic data (routine clinical evaluations and laboratory data), to provide a reliable basis and guideline for clinical diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients previously received kidney biopsy, ophthalmic examinations and routine examinations of the department of nephrology during in-hospital period with BCVA\>0.5.

Exclusion Criteria:

* Patients without retinal fundus images or kidney diseases.
* The quality of the retinal fundus images can not meet the requirement for furthur analysis.
* Severe loss of results of routine examinations of the department of nephrology.
Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®

The great toe is vital for normal, pain free ambulation. Decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis or Hallux Limitus leading to a painful great toe. Patients experience pain during ambulation especially during the push-off phase of gait. When surgery is indicated four techniques are used for hallux rigidis; cheilectomie, resection arthroplasty, arthrodesis and implant surgery (1). Endoprostetic implants are relatively new. Silicone Implants like the arthroplasty developed by Swanson (2) resulted in foreign body reactions and periarticular bone loss. Subsequent implants, in particular the metallic hemi arthroplasty with or without polyethylene articulations, have been more successful (3). Still, implants are prone to wear of the material and show higher rates of loosening and infection compared to other techniques (4;5). In the last decades several new implants are described using two non cemented pressfit components, of titanium alloy or ceramic (6-9). Between 2001 and 2004 the investigators developed a new concept with instrumentation for exact alignment to prevent for wear with loosening of the implant on the long term. The implant has bone-conserving characteristics to enable arthrodesis as a salvage procedure. It is a completely modular two-component press fit titanium alloy implant with polyethylene insert that can be used as either for hemi-, total- or revision arthroplasty.

The purpose of this study is to have an overview of clinical status of the patient implanted with the METIS® prosthesis at short term (2 years of follow-up). The objective of this study is to evaluate the safety and efficacy of the Metatarso-Phalangeal prosthesis METIS® at short term follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Have willingness to give his/her data transfer authorisation;
* has an indication of: Hallux Rigidus, Hallux Limitus with degenerative joint disease, Painful Hallux Valgus, Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, for which surgeon has recommended that a METIS® prosthesis be implanted

Exclusion Criteria:

* active infection or inflammation;
* excessive bone loss, bone deficiency or rapid joint destruction;
* suspected or documented metal allergy or intolerance;
* metatarsal head or phalangeal avascular necrosis;
* joint instability involving soft and fibrous tissue deficiency;
* severe metatarso-phalangeal axis deviation (Hallux Valgus angle \> 20°);
* prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol;
* a previous joint replacement.
The Effect of CV4 and Sacral Technique on the Alpha Bands Power

Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on nervous system functions, however, the supporting evidence for CV4 clinical benefits is promising but still poor. The osteopathic tradition considers the sacrum linked to the cranium through anatomical and functional connections. To our knowledge, no studies explored the potential effect of a sacral technique on brain activity as an indicator of a neurophysiological connection between the occiput and sacrum. This study aims to explore this effect by measuring the alpha-band activity during the application of a sacral technique (ST) compared to the CV4 application.

Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral technique (ST) and sacral sham technique (sST).

Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting state), followed by two randomized interventions. Alpha EEG will be continuously recorded during each intervention and 10 min after, for a total of approximately 50-60 min per session.

Eligibility Criteria:
Inclusion Criteria:

* Age
* Subjects had to sleep for at least 6 hours the night before the experiment

Exclusion Criteria:

* Use of Psychoactive or Psychotropic Substances
* Cerebrovascular diseases
* Recent headaches
* Use of nicotine in the 24 hours prior to the quantitative EEG registration
* Use of alcohol in the previous 12 hours.
Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood and tissue samples from patients with prostate cancer receiving androgen deprivation therapy.

OBJECTIVES:

* To identify the molecular and pathophysiological changes which occur during the early stages of androgen deprivation (AD) and during emerging castration-resistant prostate cancer.
* To test functional imaging as a non-invasive tool to measure treatment response and validate this using biological endpoints.
* To develop clinical models to predict how tumors will respond to AD and identify new targets once AD fails.

OUTLINE:

* Group A: Patients likely to receive androgen deprivation (AD) as first-line therapy undergo blood and prostate biopsy sample collection before and after treatment on days 0 and 14 or 90. Patients receive an androgen receptor inhibitor followed by maintenance with a gonadotropin-releasing hormone analogue beginning on day 0. Patients also undergo diffusion-weighted MRI, MR spectroscopic imagining, quantitative T1W mapping, and T1W perfusion sequence.
* Group B: Patients already receiving AD undergo blood and prostate biopsy sample collection within 4 weeks of diagnosis of castration-resistant prostate cancer and before initiating any second-line therapy.

Blood and tissue samples are assessed via DNA and RNA genetic analysis, gene expression studies, and comparative genomic hybridization to identify novel markers of androgen response and resistance.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * High clinical suspicion of prostate cancer, based on an abnormal digital rectal examination and PSA (\> 20 ng/mL)
  * Newly diagnosed, castration-resistant prostate cancer

    * Clinical stage ≥ T2c disease
* Significant tumor volume on initial diagnostic biopsy (\> 50% of cores)
* Likely to receive androgen deprivation therapy for prostate cancer

PATIENT CHARACTERISTICS:

* No contraindication to transrectal needle biopsy
* No contraindication to MRI or prostate needle biopsy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

This is a community-based participatory study to test a brief intervention to reduce risk for intimate partner violence (IPV) and associated unintended pregnancy among young, medically underserved women attending family planning (FP) clinics. Women ages 16-29 years utilizing FP clinics report higher rates of IPV compared to their same-age peers, experiences associated with unintended pregnancy. A critical mechanism connecting IPV with poor reproductive health is abusive partners' control of women's reproduction through condom refusal, pressuring women to get pregnant, and birth control sabotage, a phenomenon described as reproductive coercion. In the investigative team's pilot intervention study 53% of young women using FP clinics reported ever experiencing IPV, and 25% reported reproductive coercion, the combination of which was strongly associated with unintended pregnancy. The proposed reproductive coercion/partner violence intervention was developed collaboratively by community-based practitioners, advocates, and researchers, with significant input from FP clients. Designed to be implemented within routine FP care, maximizing feasibility and sustainability of this program, the intervention provides 1) client education and assessment regarding IPV and reproductive coercion; 2) discussion of harm reduction behaviors to reduce risk for unintended pregnancy and IPV victimization, and 3) supported referrals to IPV victim services. This is a full-scale RCT to assess the effects of this innovative program on IPV, reproductive coercion and unintended pregnancy, major health threats for medically underserved women. Evaluation of this intervention will involve random assignment of 25 FP clinics (unit of randomization) in Western PA to either intervention or control (i.e., standard-of-care) conditions. Female FP clients ages 16-29 (N=3600) will be assessed at baseline, 12-20 weeks (FU1), and 12 months (FU2) to assess intervention effects on knowledge and behaviors related to IPV, reproductive coercion and related harm reduction, as well as unintended pregnancy. Data will be collected via audio computer-assisted self-interview in English or Spanish. Chart extraction will track clinic utilization, pregnancy testing, and diagnosed pregnancies. Regression models appropriate for longitudinal data from cluster-randomized trials will be used to estimate intervention effects.


Eligibility Criteria:
Inclusion:

* female clients
* ages 16-29
* English or Spanish speaking
* able to provide their own consent
* plan to be in area for the next 12 months
* willing to be contacted for follow up survey and able to provide additional contact information

Exclusion Criteria:

* female clients not of the specified age range
* neither English nor Spanish speaking
* clients who are intoxicated or otherwise not able to provide their own consent
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
* C-peptide (fasting) \>=1.0ng/mL;
* HbA1c \>=7.0% and \<=10.0% at screening;
* BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening;
* stable weight +-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

* history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
* evidence of clinically significant diabetic complications;
* symptomatic poorly controlled diabetes;
* clinically symptomatic gastrointestinal disease;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
Immune Reconstitution After Allo-HSCT and Blinatumomab

The goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• Effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation.

Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab treatment, 6 months and 1 year after transplantation.

Researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if TCR or BCR expression differs.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 16-65 years old
2. KPS score \> 60 or ECOG score 0-2
3. diagnosed as B-ALL, a) disease status \> CR1 at the time of transplantation; Patients beyond CR1 or induction failure could be free of minimal residual disease (MRD). b) any residual disease, defined as \>0.01% leukemic cells by flow cytometry, BCR-ABL transcript ≥ 1 in 10000 by PCR, or high-risk genetic abnormality
4. neutrophil count ≥0.5×10\^9/L and platelet count ≥20×10\^9/L
5. creatinine clearance ≥30ml/min; Alanine aminotransferase/aspartate aminotransferase ≤5 times the upper detection limit; Total bilirubin ≤3 times the upper limit of detection
6. The first initiation of berintuzumab therapy was within 60-100 days after transplantation
7. without evidence of active acute graft-versus-host disease (aGvHD)

Exclusion Criteria:

1. With serious basic diseases of important organs, such as myocardial infarction, chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction, gastrointestinal dysfunction, etc
2. With clinically uncontrolled active infection
3. Patients with central nervous system involvement before transplantation
4. Poor graft function (PGF) occurred after allo-HSCT
5. Patients with second allogeneic transplantation
Exercise Intervention Study for Pancreatic Cancer Patients

The purpose of this study is to compare the effects of two specific exercise interventions and one standard care control arm on physical functioning.The investigators expect that supervised training is most beneficial to the patients. However, they also expect some benefit for patients in the home-based training.

The randomized-controlled balanced-parallel-group trial included 65 adult pancreatic cancer patients (stage I-IV) from the University Surgery Clinic in Heidelberg. The study compared two specific exercise interventions and one standard care control arm. The intervention programs were (1) a 6-month supervised moderate-to-high-intensity, progressive resistance training, and (2) a 6-month home-based exercise training. Thus, the two interventions differed primarily by the intensity and mode-of-administration of the intervention. Both interventions started at the earliest 8 weeks after surgery to allow for wound healing until Maximum 12 months after the surgery. The supervised progressive training started with only moderate-intensity training during the first 4 weeks. Only patients without comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability) were eligible.

The primary objective is to compare the effects of the different interventions on physical functioning, measured as change from baseline to 6 months. Additional endpoints are overall quality of life, fatigue, endurance, and strength performance, adherence to the interventions, discontinuation of adjuvant therapy, body weight and composition, disease progression, overall and progression-free survival. All outcomes has been assessed every 3 months for a minimum follow-up period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cancer patients (stage I-IV)
* Patients ≥ 18 years of age
* Resection performed at the University Clinic of Heidelberg
* Sufficient German language skills
* Signed informed consent

Exclusion Criteria:

• Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)
Olive Leaf Extracts in the Control of Hypertension

This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

Patients over 18 years of age with:

Arterial hypertension (hypertension).

This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

All the population will benifit of a biological assessment which include:

Complete lipid profile, blood sugar, creatinine

one population will be randomized:

The population of patients with hypertension.

For patients in the hypertension group:

A blood pressure with holter will be carried out for 24 hours .

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age with:

Arterial hypertension (hypertension)

Exclusion Criteria:

* . Exclusion criteria: None.