cyrilzakka/clinical-trials huggingface dataset:
Dose Response and Receptor Selectivity of Beta-blocker Effects on Bone Metabolism

This study is designed to answer the question as to whether the sympathetic nervous system is an important determinant of bone metabolism in humans.

In postmenopausal women, who have increased sympathetic outflow, to test the hypothesis that treatment with low doses of a non-selective β-blocker (propranolol) will increase serum markers of bone formation and reduce markers of bone resorption (Aim 1a); and using increasingly β1-AR (adrenergic receptor) selective blockers (atenolol and nebivolol), to better define the β-adrenergic receptor selectivity (β1 versus β2) in the regulation of bone turnover by sympathetic outflow in humans.

Eligibility Criteria:
* Inclusion Criteria:

  * at least 5 yrs since their last menses
  * Follicle Stimulating Hormone (FSH) \> 20 IU/L
* Exclusion Criteria:

  * Abnormality in any of the screening laboratory studies
  * Presence of significant liver or renal disease
  * Malignancy (including myeloma)
  * Malabsorption
  * Diabetes
  * Hypoparathyroidism
  * Hyperparathyroidism
  * Acromegaly
  * Cushing's syndrome
  * Hypopituitarism
  * Severe chronic obstructive pulmonary disease
  * Undergoing treatment with any medications that affect bone turnover, including the following:
* adrenocorticosteroids (\> 3 months at any time or \> 10 days within the previous yr)
* anticonvulsant therapy (within the previous year)
* pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)
* calcium supplementation of \> 1200 mg/d (within the preceding 3 months)
* bisphosphonates (within the past 3 yrs)
* denosumab
* estrogen (E) therapy within the past year
* treatment with a selective E receptor modulator within the past year
* teriparatide within the past yr
* anti-hypertensive therapy

  * Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm
  * Recent (within the past 6 months) fracture
  * Serum 25-hydroxyvitamin D levels of \< 20 ng/ml
  * Resting blood pressure \>140/90 mm Hg or those with hypotension (systolic blood pressure \<110 mm Hg), heart rate \< 60 bpm
  * History of asthma
Is it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?

In this prospective randomized controlled study, it is aimed to investigate the effects of guidewire advanced through a previously placed double j stent on postoperative complications, operation time and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Double J stent placed at least 2 weeks ago

Exclusion Criteria:

* Active urinary tract infection
Proton Pump Inhibitor Use and Dental Implant Success

The goal of this observational study is to evaluate the effects of proton pump inhibitors (PPIs) on the surrounding bone and the survival of dental implants. The main questions it aims to answer are:

Does PPI use affect the survival rate of dental implants? Does PPI use influence crestal bone loss and fractal dimension (FD) of the surrounding bone?


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old,
* Having a history of PPI use for more than six months,
* Having at least one bone-level and axially placed dental implant in the maxilla or mandible,
* Having a minimum of one year elapsed since the prosthetic restoration following dental implant placement,
* Having undergone routine clinical follow-ups and radiological evaluations with periapical radiographs taken using the parallel cone technique after dental implant placement.

Exclusion Criteria:

* Individuals with a history of PPI use for less than six months,
* Individuals with periapical radiographs of low image quality or with artifacts,
* Individuals for whom the regions selected for fractal analysis on periapical radiographs are not appropriately sized,
* Individuals who have not undergone routine clinical and radiographic follow-ups.
ERP Based Single-dose Predictions of Stimulants

The purpose of this study was to see if the clinical outcome of stimulant medication (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant medication. (ERPs are extracted from electroencephalographic (EEG) registrations during the performance of an attention task).

In the pediatric neuropsychiatric clinic of Ostfold Hospital Trust, Norway, patients diagnosed with attention deficit hyperactivity disorder are tested with quantitative EEG (QEEG) and ERPs to supplement the neuropsychological examination. In the majority of cases a systematic four weeks trial on stimulant medication is offered, and the clinical effects are evaluated at the end of the try-out period. This procedure is a clinical routine. In this study patients and parents were asked if they were willing to complete a second QEEG/ERP test on a single dose of stimulant medication shortly before the onset of the four weeks trial. They were explained that the aim of the study was to search for predictors of clinical response. They were also informed that this second test was completely voluntary. (In fact the vast majority were quite enthusiastic). The patients were characterized as responders (REs - medication continued) or non-responders (non-REs - medication stopped) based on explicit criteria. The single-dose induced changes in ERPs (and behavioral parameters from the attention test; number of errors, reaction times) were examined, and differences between REs and non-REs were calculated.

If the analysis of data show that one or several variables are significantly different in REs and non-REs with large effect sizes, these findings may eventually result in the development of a useful clinical tool.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the clinic diagnosed with Attention Deficit Hyperactivity Disorder. Cases With comorbid diagnoses such as emotional or behavioral disorders, learning disabilities or high functioning autism are included.

Exclusion Criteria:

* Patients With intelligence coefficients below 70 or a diagnosed neurological disease are excluded.
Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation

Physiological changes caused by hematological diseases associated with high dose chemotherapy have a negative impact on patient's functionality, making them more fragile and vulnerable after hematopoietic cell transplantation. Currently, randomized studies have shown that physical exercise can contribute to improve Quality of Life of these patients. In this randomized controlled trial, we will study the effect of using the bicycle ergometer on the physical performance of patients undergoing transplantation of hematopoietic stem cells (HSCT).

The sample consists of 30 patients diagnosed with leukemia, lymphoma and multiple myeloma, undergoing high-dose chemotherapy and hematopoietic stem cells transplantation, who will be randomized into two groups. The results of muscle strength in the lower limbs, general mobility, fatigue and clinical symptoms will be compared between the control group and the experimental group.

The control group will perform an exercise program based on the standard protocol of the physiotherapy service, where exercises are performed to gain strength in muscle groups of the upper and lower limbs, range of motion, balance and functional movements. The experimental group will perform the same exercises as the control group, added to a training program using a bicycle ergometer, with an incremental load (from 60% to 70% of the maximum heart rate) for 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-70 years) scheduled to perform the first HSCT;
* Be with a preserved neurological function and full cognition;
* Have clinical conditions that allow participation in the motor physiotherapy program;
* Be agreed with a study proposal and sign the free and informed consent form (ICF).

Exclusion Criteria:

* Develop clinical complications that contraindicate the performance of motor physiotherapy including the practice of the cycle ergometer;
* Present a previous musculoskeletal alteration that interferes with the performance of physical performance assessment tests;
* Recent cardiovascular or pulmonary disease;
* Psychiatric or neurological disorder;
* Need for gait assistance or presence of bone metastasis
* Adherence below 50% of the total motor physiotherapy protocol.
With-Me - Technology-Aided Phone Coaching for Occupational Health Study

The purpose of this study is to examine whether the technology (web-based coaching, profiling and suggestion tool) brings added value to the traditional phone coaching in occupational health context. The interventions are phone counseling interventions. The other intervention exploits additionally a specific web-based coaching, profiling and suggestion tool.

The study focuses on mental well-being. The both interventions include intensive and independent phase.

The intensive phase lasts 13 weeks. In the intensive phase, goals for the coaching are defined. Coach calls the customer every two weeks and they discuss about the actions that took place in the previous two weeks and what they need to do in the next two weeks. In the technology-aided arm, customers get and analysis of their change needs via digital tool. Based on the change needs they receive task/goal suggestions from which they need to choose 3. Coach is able to see these choices and exploits it in the coaching. The selected behavioral activation interventions are delivered to customer utilizing a web-based coaching tool.

The independent phase lasts 13 weeks. In the independent phase, technology-aided group is coached via the digital tool. The phone counseling group gets 3 phone calls.

Eligibility Criteria:
Inclusion Criteria:

* At least a bachelor level degree
* Age over 18 years
* Decreased psycho-physic state (own assessment)
* Is in a relationship
* Motivated to enhance own well-being and willing to change lifestyle, to do exercises related on mental well-being and relationship
* Willing to use technological wellness coaching tools, familiarity with technology

Exclusion Criteria:

* Work includes night shifts
* Acute health conditions or serious diseases
* Chronical pain affecting functionality
* Long period(s) of absence from work during the coaching period (e.g. long vacation, alternation leave, parental leave, pension)
* Participation in some other study
the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women

The present randomized double blind study has been carried out in Gynecology and Obstetrics Department, Faculty of Medicine, Zagazig university on 70 women were previously received clomiphene citrate alone as management of infertile anovulatory PCOS women, but giving improper endometrial thickness \< 7mm during the period from March 2019 to September 2019

Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in infertile women. Infertility affects 40% of women with PCOS. Understanding the main causes of infertility and selecting an appropriate treatment plan is a diagnostic and therapeutic priority The aim of this work was to compare the effect of Clomiphene citrate plus Estradiol Valerate versus Letrozole on endometrial thickness and pregnancy rate in infertile PCOS women underwent ovulation induction

The study was designed as a randomized double blind study using a computer-generated randomization list and sequentially numbered opaque sealed envelopes, each containing the allocation information written on a card. Envelopes were opened sequentially by a study nurse to allocate patients to the assigned group. These patients were divided into two groups:

1. Group A (clomiphene citrate \& estradiol group): included 35 anovulatory PCO patients who received clomiphene citrate (Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg daily from cycle day 3 to 7 with estradiol valerate 4-mg (two white tablets of cyclopregynova) from cycle day 8 to 14.
2. Group B (Letrozole group): included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-35 years old with complete infertility workup
* patients diagnosed as having PCOs women
* Normal semen analysis

Exclusion Criteria:

* Patients with male factor infertility, hyperprolactinemia, thyroid disorder.
* Patients with any tubal pathology or uterine pathology.
* Contraindication of ovulation induction, (Multiple ovarian cysts or allergy to inducing agent "clomid").
* Known or suspected pelvic infection (PID).
Body Temperature in Persons With Tetraplegia When Exposed to Heat

The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However, the consequences of impaired regulation of normal body temperature on cognitive performance of persons with tetraplegia is not known. This study will provide the preliminary findings necessary for future work to design and explore physical and medical interventions to improve temperature regulation in those with tetraplegia with the goal of improved clinical care, health, and quality of life.

The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10 controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours. Physiological as well as psychological processes will be monitored in all subjects during the study for safety and to determine differences in responses to exposure to hot ambient temperatures

After a cervical spinal cord injury (SCI) the motor, sensory and autonomic deficits cause, among other detriments, a blunted ability to maintain a constant core temperature. Impaired thermoregulation leaves persons with tetraplegia more susceptible to hyperthermia than able-bodied persons (AB). There has been a paucity of work addressing the thermoregulatory responses of persons with SCI to hot ambient temperatures, and even less study addressing the effect of these temperatures on cognitive performance. The goals of this pilot study are: to improve our understanding of the thermoregulatory mechanisms of individuals with tetraplegia when exposed to heat and to determine the effect of impaired thermoregulatory mechanisms on cognitive performance during exposure to 35°C for up to 2 hours. In order to address our goals we have designed a study methodology which consists of comparing the physiological and psychological responses of the two study groups (tetraplegia versus AB controls) from thermoneutral (27°C) to hot (35°C) environments.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 65 years of age;
2. Duration of injury ≥ 1 year;
3. Level of SCI C4-T1;
4. Euhydration (Subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to study); and
5. Age (± 5 years) and gender matched AB control group.

Exclusion Criteria:

1. Known heart and/or blood vessel disease;
2. High blood pressure;
3. Kidney disease;
4. Diabetes mellitus;
5. Acute illness or infection;
6. Dehydration;
7. Pregnant women;
8. Untreated thyroid disease, and
9. Broken, inflamed, or otherwise fragile skin.
Assessment of Visual Performance in Patients With Low Levels of Astigmatism

To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* 50-75 years of age
* Proof of eye exam within the last 12 months
* Operated for uncomplicated, age-related cataracts \>3 months
* Corneal astigmatism of 0.5-0.75 diopter

Exclusion Criteria:

* Previous ocular or refractive surgery/trauma
* Clinically severe corneal dystrophy
* Amblyopia
* Degenerative visual disorders
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.


Eligibility Criteria:
Inclusion Criteria:

* Participant is 18 years of age or older on the day of inclusion.
* Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
* Participant in reasonably good health as assessed by the Investigator.
* Participant willing and able to give informed consent.
* For a woman, inability to bear a child or negative serum/urine pregnancy test.

Exclusion Criteria:

* Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
* An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
* Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or review of systems.
* Self-reported history of severe adverse event to any influenza vaccine.
* Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 2.
* Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.\*
* Immunocompromising condition or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
* Receipt of blood or blood products within the 3 months preceding enrollment in the study.
* Diabetes mellitus requiring pharmacological control.
* Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
* Person deprived of freedom by an administrative or court order (having legal or medical guardian).
* For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
* Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Prior personal history of Guillain-Barré syndrome. \* Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.
A Long-Term Follow-Up Basket Study for Participants Treated with SynKIR Chimeric Antigen Receptor (CAR) T Cell Product

The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.

This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products.

No investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol.

In accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics.
2. Participant is willing and able to comply with the study requirements.

Exclusion Criteria:

There are no specific exclusion criteria.
Clinical Specimen Collection From Pompe Disease Patients

Clinical specimens are required from individuals with Pompe Disease to support process and analytical development for a genetically modified autologous bone marrow cell product currently in preclinical research, FTX-PD01. The intent is for this product to be investigated in a subsequent clinical trial under a future FDA IND to treat Pompe Disease. Enrolled participants provide a venous blood specimen (approximately 20mL) to be used in preclinical studies and research and development of FTX-PD01. Subjects may eventually be asked to undergo mobilized leukapheresis for bone marrow stem cell collection and their specimens will be used to further develop the FTX-PD01 cell product, including a cGMP compliant process to be applied under the future FDA IND.

This protocol is to collect blood and HSPC specimens from individuals with Pompe Disease. The first blood draw will be done at the first study visit and if eligible, the second collection will be done via mobilized leukapheresis at the second visit. The mobilized leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for mobilized leukapheresis.

Donors will be males or females between and including the ages of 3 years and 30 years. Volunteers will provide written informed consent and meet all inclusion and exclusion criteria. Each participant can be in the study for up to 120 days (3 months).

The study will be conducted in accordance with human research for the purposes of obtaining clinical specimens for research. There is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. The data will be summarized in future studies reporting results from a future clinical trial under FDA IND.

Eligibility Criteria:
Inclusion Criteria:

* Male of female aged 3-30
* Documented diagnosis of Pompe Disease
* Participants who has not participated in a cell or gene therapy trial for Pompe Disease

Exclusion Criteria:

* Active acute infection at screening
* Uncontrolled diabetes
* Uncontrolled hypertension
* Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
* Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate blood collection or mobilized leukapheresis procedure
* Systemic chemotherapy less than or equal to 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to leukapheresis
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening
* Any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures