cyrilzakka/clinical-trials huggingface dataset:
Coordinated Reset Deep Brain Stimulation

The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months.
2. Tolerates \> 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
3. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

1. Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
2. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
Cost-effectiveness Study of Epoetin Alfa and Darbepoetin Alfa in Adult Patients With Cancer Who Have Anemia

The purpose of this study is to evaluate the cost-effectiveness of epoetin alfa compared with darbepoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer. Epoetin alfa and darbepoetin alfa are genetically engineered proteins that stimulate red blood cell production.

Anemia has been identified as a common complication and a widespread problem in the cancer population. Anemia is a condition in which a patient has below normal levels of hemoglobin, the substance in red blood cells that carries oxygen to all parts of the body. People with severe anemia may experience fatigue and shortness of breath with activity. Therefore, this condition can have a negative influence on a person's quality of life. Epoetin alfa and darbepoetin alfa, used to treat anemia in cancer patients, are genetically engineered proteins that stimulate red blood cell production. This study investigates treatment of anemia using either epoetin alfa or darbepoetin alfa during chemotherapy in adult patients with cancer. The study is intended to collect information on normal medical practice and routine anemia management performed at the participating centers. This is an observational, non-randomized, prospective, comparative, parallel-group survey performed in The Netherlands. Patients with various severities of disease may enter the survey as soon as either their epoetin alfa or their darbepoetin alfa treatment starts and will be followed until the end of their epoetin alfa/darbepoetin alfa treatment. Patient data are collected, on average, once monthly (depending on the treatment being received) and this continues until 4 weeks after the end of treatment with epoetin alfa or darbepoetin alfa. An assessment of cost-effectiveness will be made for both treatments. The assessment of cost-effectiveness will be based on the following: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of either epoetin alfa or darbepoetin alfa, use of blood transfusions, and serum iron levels and iron supplementation. Safety evaluations include the incidence of serious and non-serious adverse events. Because the study involves only collection of information, no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor. Epoetin alpha and darbepoetin alpha are administered according to routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of solid tumors, multiple myeloma (Kahlers' disease), non-Hodgkin lymphoma or Hodgkins' disease
* Patients must already be receiving chemotherapy or start their first cycle within a week of enrollment
* Patients must receive either epoetin alfa or darbepoetin alfa treatment (expected treatment duration is at least 4 weeks)

Exclusion Criteria:

* Patients not meeting all of the inclusion criteria for entry into the study
* Patients who cannot read the Dutch language and/or do not understand the Dutch Informed Consent Form
MDR EZ Pass and Precision Flexible Reamer

The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation. Ultimately, clinical performance will be assessed through survey questions that evaluate the safety and performance of these instruments.

The primary objective of the study is to assess performance, clinical benefits and safety of the EZPass Suture Passer and the Precision Flexible Reamer Instrumentation.

Performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery.

Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.

Eligibility Criteria:
Inclusion Criteria

* EZ Pass Suture Passer:

  - Intended as an open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue.
* Precision Flexible Reamer:

  * This device is a hand held, or hand-manipulated device, intended to be used in ACL and PCL reconstruction surgeries and is intended for medical purposes to manipulate tissue, or for use with other devices in these surgeries.

Exclusion Criteria

* EZ Pass Suture Passer:

  - Any use other than the approved uses indicated in the Instructions for Use (IFU).
* Precision Flexible Reamer:

  * Any use other than the approved uses indicated in the Instructions for Use (IFU).
Influence of Latent Miofascial Trigger Points in the Vertical Jump in Female Voleyball Players

To evaluate the effects of dry needling of latent myofascial trigger points on vertical jump height in female volleyball players

Evaluate a sample of female volleyball players after using dry needling on latent myofascial trigger points and verify if it would have an improvement of the vertical jump

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volleyball players
* No Lower limbs injuries in the last 6 months
* Presence of latent trigger points in gastrocnemius
* Familiar with performing CMJ test

Exclusion Criteria:

* Active trigger points in the lower limbs
* Any contraindication of usind dry needling
* Any pathology that prevented the performance of CMJ test
Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome

This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. This information will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in IBS, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.


Eligibility Criteria:
IBS-C and IBS-D SUBJECTS:

Inclusion Criteria:

* Clinical diagnosis of IBS-C or IBS-D
* Age 18 to 65

Exclusion Criteria:

* Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
* Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
* Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
* Bowel preparation for colonoscopy within the past week
* Pregnancy or plans to become pregnant within the study time frame
* Vulnerable adults
* Age greater than or equal to 66
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes

HEALTHY SUBJECTS:

Inclusion Criteria:

* Age 18 to 65
* No clinical diagnosis of IBS-C or IBS-D

Exclusion Criteria:

* Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
* Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
* Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
* Bowel preparation for colonoscopy within the past week
* Pregnancy or plans to become pregnant within the study time frame
* Vulnerable adults
* Age greater than or equal to 66
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes
* Clinical diagnosis of IBS-C or IBS-D
Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients

The present bicentric study has the aim to investigate the effectiveness of the peer supported mentoring program 'Peer2Me' with regard to psychosocial parameters using a prospective Comprehensive Cohort Design. Over a period of three months, acutely ill patients in the intervention group are accompanied by a mentor with the same disease and of similar age. Patients in the control group receive a one-time consultation. Before and after the intervention, mentors and mentees are interviewed about their psychosocial distress and quality of life.

After successful piloting of the mentoring program "Peer2Me", the mentoring program developed by us is now to be implemented and evaluated in a large-scale study in a second step, in order to be able to derive clinically relevant results.

A total of 180 acutely ill adolescent and young cancer patients (AYA) between the ages of 18 and 39 will be included in the study (intervention and control group). Again, young former cancer patients who have completed treatment will act as mentors and accompany acutely ill AYAs in the period after diagnosis for a period of three months. Prior to their assignment, the mentors take part in a training course, which includes the teaching of suitable conversation techniques, core topics in dealing with the cancer and advice on further care structures. Patients in the control group receive 30 minutes of standardized counseling regarding psychosocial care needs, including appropriate informational materials, during AYA consultation hours at both clinic sites. The study includes three measurement time points: t1: before the intervention; t2: after the end of the intervention; t3: 3 months after the end of the intervention. At all time points, participants will be surveyed using standardized questionnaires. With the help of these data and a comprehensive statistical analysis, the investigators want to make valid statements regarding the effects of peer mentoring on changes in psychological well-being as well as on social support and coping with illness.

Eligibility Criteria:
Inclusion Criteria:

* Cancer disease between the ages of 18 and 39 (all tumor entities)
* completion of acute treatment at least 2 years ago (mentors)
* curative prognosis
* Native language German or fluent German speaker
* first cancer diagnosis in the last 6 months (mentees, all tumor entities)
* curative prognosis

Exclusion Criteria:

* existing and already diagnosed psychiatric disease, ongoing psychotherapy and/or existing suicidal tendency
* palliative treatment approach
Cologne Cohort of Neutropenic Patients (CoCoNut)

The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.

This prospective cohort was established with the aim of a comprehensive data collection of all patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne.

Eligibility Criteria:
Inclusion Criteria:

* immunosuppressed patients

Exclusion Criteria:

* none
Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs

To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.

Erector spinae plane (ESP) block is a recently described technique which may be an alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. ESP does not have the same risk of pneumothorax as PVB.

Epidural analgesia has become the standard of care. Although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. Many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. There are disadvantages to thoracic epidural analgesia. They are technically challenging to insert, with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and if opioids used, urinary retention and pruritus. Patients can develop a motor block and are unable to mobilize with an epidural in situ.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple fracture ribs.

Exclusion Criteria:

* Patient refusal.
* Patients with pre-existing infection at the block site.
* Coagulopathy.
* Allergy to local anesthetics.
* Pre-existing neurological deficits.
* Psychiatric illness.
Nasal Obstruction in Sleep Apnea Patients Compared to the General Population

Recent clinical findings of research at Trondheim University Hospital suggest that surgical correction of the nose septum in addition to volume reduction of the nose cavity may be beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea syndrome(data not yet published).

This study aims to compare nose obstruction prevalence in sleep apnea patients and the general population


Eligibility Criteria:
Inclusion Criteria:

* ???

Exclusion Criteria:

* ???
Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19

Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity.

An early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments


Eligibility Criteria:
Inclusion Criteria:

* Covid positive (RT-PCR)

Exclusion Criteria:

* Unable to answer questions by telephone or teleconsultation directly or through a relative, minors under 16 years of age
Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence

To compare the effects of Pilates exercises versus pelvic floor muscle exercises among elderly women with urinary incontinence. The study is a single-blinded randomized clinical trial. 70 patients(calculated through PASS version 15 software) will be selected. Subjects will be screened whether they met inclusion and exclusion criteria. The participants for this study will be elderly women with urinary incontinence. The participants will be recruited from SIPMR and Civil hospital Karachi. The initial assessment will be done by Medical Consultant. Patients must fulfill inclusion criteria. Consent must be taken from each patient and samples will be collected in the given time frame and patients will be randomly assigned(through a randomization sheet) to the treatment groups. Treatment group 1 will be doing Pilates exercises and treatment group 2 will be doing Pelvic floor muscle exercises. EMS will be given to both treatment groups. A voiding diary, Stamey's urinary incontinence system, and IQOL questionnaire will be used at baseline assessment and at the end of treatment sessions. 12 treatment sessions will be given, 3 visits each week for 4 weeks. The data will be analyzed on SPSS version 21. : Non-probability purposive sampling technique will be used for selecting individuals. Percentages and frequencies will be calculated for categorical variables and parametric and nonparametric tests will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Elderly females from an outpatient setting of Sindh Institute of physical medicine and rehabilitation and civil hospital Karachi.
* Patients aged ≥60 years.
* Experienced stress or mixed urinary incontinence symptoms at least 3 times/ week for 3 months or more.

Exclusion Criteria:

* Have limited mobility (unable to move without crutches, walker, or a cane).
* Have untreated chronic constipation or have experienced any stool or mucus leakage.
* Organ prolapse surgery within the last year.
* In the last 3 months, any active urinary or vaginal infection.
* Malignancy
Health Related Quality of Life of Youth and Young Adults With Hemophilia A

The relevance of the study will be in establishing whether Health Related Quality of Life (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant changes in health or personal circumstances related to the transition from youth to adulthood. This may support the future use of HRQoL measures as part of routine care in order to identify important changes that are not detectible by other clinical means.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe Hemophilia A (factor level ≤5%)
* Receiving Helixate FS as on-demand treatment or prophylaxis therapy at time of informed consent
* Patient age 14 to 29 years at the time of recruitment
* Complete informed consent process and documentation; (Patients under age 18 must assent in addition to consent of legal guardian)
* Willing/able to follow study protocol, including keeping a bleeding and treatment diary
* Able to communicate clearly in either English or French - both written and verbal communication is essential.

Exclusion Criteria:

* Known inhibitor at time of recruitment (\> 0,5 Bethesda units) or immune tolerance therapy at time of recruitment
* HIV positive
* Symptomatic Hepatitis B or C infection or active treatment for hepatitis B or C
* Inability to comply with study protocol
* Hypersensitivity to Helixate FS or to any ingredients in the formulation or component of the container
* Hypersensitivity to mouse or hamster protein
* Unsuitable to participate in study for any other reason as assessed by investigator
Addressing Tetrachloroethylene Exposure in an Impacted Community

Groundwater in Martinsville, IN, is contaminated by volatile organic compounds (VOCs), tetrachloroethylene (PCE) and trichloroethylene (TCE). Indoor air in some residential and commercial buildings is also contaminated with PCE and TCE. This study is being conducted to better understand the impact of low-level exposures to these compounds on community members' health. Data collected in this study will be used to help the community identify a course of action.

Martinsville, IN, is a community of 11,000 people that overlays four groundwater contamination sites, including a U.S. Environmental Protection Agency (EPA)-designated Superfund site. The total area of groundwater contamination is over 60 acres and lies within a single aquifer. The contaminates are chlorinated volatile organic compounds (VOCs), primarily tetrachloroethylene (PCE) and trichloroethylene (TCE). These contaminants are thought to originate from several dry cleaning and metal degreasing operations. An activated carbon filtration system has been in operation since 2005 to remove PCE and chlorinated VOCs from the municipal water, which now meets EPA drinking water standards. However, a recent report from the Agency for Toxic Substances and Disease Registry concludes that people's health may be harmed by breathing indoor air contaminated via vapor intrusion, the migration of volatile compounds from contaminated groundwater and soil into buildings above. The long-term goal of this research is to understand how PCE exposure in communities affects health and to empower community members' participation in environmental health decision-making. In this project researchers will work with the community of Martinsville, IN to:

1. Determine the extent and exposure levels to the contaminants by measuring the contamination in residents and at their homes.
2. Assess the community's concern and perceptions about the contamination and associated health risks.
3. Study the impact of the contaminants on visual and neurocognitive functions.
4. Compare cancer rates in Martinsville to county and state rates.

The above information will help researchers and community partners co-design a targeted educational campaign to reduce community members' exposure to the contaminants.

Eligibility Criteria:
Inclusion Criteria:

* Residents of Martinsville, Indiana
* 18 years or older