cyrilzakka/clinical-trials huggingface dataset:
Effect of Exercise on Post-Covid Symptoms

The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), Pittsburgh sleep quality index (PSQI) before and after the study.

After COVID-19, musculoskeletal pain, anxiety, and sleep problems can continue. The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. The study was performed at Gaziosmanpaşa Education and Research Hospital with 76 post-covid patients that were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), and Pittsburgh sleep quality index (PSQI) before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* to be between the ages of 18-65
* to be diagnosed with Covid-19 in the last 3 months
* to have a negative PCR test, or to have completed the 14-day isolation period

Exclusion Criteria:

* have undergone surgery in the last 6 months
* have severe mental retardation that would prevent communication
Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions

The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany.

The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT \[real-time\] -PCR \[polymerase chain reaction\].

The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.


Eligibility Criteria:
Inclusion Criteria:

* Positive informed consent
* Patients with suspected preinvasive genital lesion
* Patients with confirmed genital lesion (both preinvasive and invasive)
* Contact via dept. of obs/gyn of luebeck university
* Complete set of data

Exclusion Criteria:

* Incomplete set of data
* Negative informed consent
Effects of Vitamin D in Parkinson's Disease (PD)

A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.

The proposed study is a randomized, double-blinded, placebo controlled intervention trial to measure the effects of vitamin D at (10,000IU/day) versus placebo on balance and falls in Parkinson's disease. The investigators will measure static, dynamic, and ambulatory balance, as well as strength, falls, and cognition before and after 16 weeks of therapy. Dynamic posturography will be used to measure static and ambulatory balance, a device called iMOBILITY will measure a timed up and go, and strength will be measured with the Biodex machine checking knee flexion and extension. Multiple quality of life and cognitive tests will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease;
* ability to ambulate 50 feet;
* ability to cooperate with balance testing;
* vitamin D level less than 40ng/ml;
* balance problems;
* ability to walk 50 feet without the help of another person

Exclusion Criteria:

* MMSE \< 25;
* another neurological or orthopedic deficit that in the examiner's opinion would affect testing;
* history of renal stones or hypercalcemia;
* unwillingness to not be on other vitamin D supplementation during the study
Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences

The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.


Eligibility Criteria:
Inclusion Criteria:

* good health
* English fluency
* willing to provide contact information for 4-6 close others
* willing to provide digital photographs of 2 close others
* own a smartphone

Exclusion Criteria:

* presence of medical devices, implants, or other metal objects in or on the body that cannot be removed
* tattooed eyeliner
* a body habitus prohibiting MRI scanning
* claustrophobia
* self-reported chronic mental or physical illness
* current and regular use of prescription medication
* previous history of having difficulty taking pills
* current use of opioid analgesics
* depressive symptoms above a 9 on Patient Health Questionnaire
* excessive alcohol use
* positive urine drug test
* body mass index (BMI) greater than 35
* pregnancy or plans to become pregnant in next 6 months
* positive urine pregnancy test
Compare Patients' Perception of Surgical Experience Based on Garment

This study seeks to compare how patients rank perception of anxiety, modesty, dignity and overall satisfaction when patients are provided with either a standard patient gown or a standard patient gown plus a pair of specialized surgical undergarments (COVR Medical) for orthopedic surgical procedures.

Given the movement in patient modesty, and the limited number of studies focused specifically on how preserving patient modesty/privacy impacts the patient's perception of the hospital experience, targeted studies with larger sample sizes are clearly needed to better understand these complex interactions. This study seeks to compare how patients rank perception of anxiety, modesty, dignity and overall satisfaction when patients are provided with either a standard patient gown or a standard patient gown plus specialized surgical undergarments (COVR Medical) for orthopedic surgical procedures. The investigators hypothesize that the group with the standard patient gown plus a specialized surgical undergarment will have lower anxiety and increased perception of modesty, dignity, and satisfaction. A secondary objective is to determine whether there is a difference in treatment surgical subgroups regarding anxiety, modesty, dignity, and overall satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo surgery by a musculoskeletal surgeon at The CORE Institute orthopedic Specialty Hospital (CISH).
* Adults 18 years or older.
* Will receive orthopedic surgery of the lower extremity, upper extremity or spine.
* Speaks, reads, and understands English
* Enrolled pre-operatively within 3 weeks of surgery date.

Exclusion Criteria:

* Unwilling to provide informed consent.
* Unwilling to participate in surveys.
* Body habitus outside of the COVR medical size range. (See Appendix 1)
* Procedure that does not meet the medical billing and coding definition of Surgery.
* Incarcerated.
Noninvasive vs. Invasive Lung Evaluation

Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping as it pertains to the detection of National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first line, treatment naive, non-squamous Non-Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Patients with NSCLC, which is: (1) Biopsy-proven (confirmatory biopsy must have been collected within 12 months prior to enrollment), (2) Metastatic (Stage IV, Stage IIIB when curative intent is not an option, or relapsed/recurrent disease after original diagnosis of Stage I-IIIA), (3) Non-squamous histology (mixed squamous and adenocarcinoma is allowed), (4) No prior treatment for advanced stage NSCLC: (a) Resection of or radiation to a single metastatic site is allowed if there are other untreated and measurable sites of metastatic disease at the time of enrollment. (b) Patients who have previously undergone surgical resection or radiation for Stage I-IIIA NSCLC are eligible if primary treatment was completed at least 6 months prior to the development of metastatic disease; for patients who received adjuvant systemic therapy, the last dose of treatment must be given at least 6 weeks prior to enrollment.
* Age ≥ 18 years
* Ability to understand a written informed consent document, and the willingness to sign it.
* Willingness to provide blood sample at the time points of pre-treatment, approximately 2 weeks after initiation of systemic treatment, and end of study).
* Patient has or will have standard-of-care tissue genotyping ordered. If the physician intends to order tissue genotyping, but there is insufficient material for analysis, the patient is still eligible for enrollment.

Exclusion Criteria:

* Pregnancy
* Any other concurrent malignancy except for localized, non-melanoma, cutaneous cancer or non-invasive cervical cancer. Any prior cancer other than NSCLC must have occurred more than 2 years prior to study entry with no evidence of currently active disease.
* Prior treatment for metastatic NSCLC including but not limited to: (1) Systemic treatment (targeted therapy, chemotherapy, immunotherapy, biologic therapy, etc.), (2) Resection of a metastatic lesion if the resected metastasis had been the only site of measurable metastatic disease, or resection of more than one metastatic lesion, (3) Radiation of a metastatic lesion or resection bed if given to the only measurable site of metastatic disease, or radiation to more than one metastatic lesion.
Outcomes With Fractional Flow Reserve in Chronic Coronary Syndrome

The use of fractional flow reserve (FFR) to assess the functional relevance of coronary stenoses has been demonstrated to reduce the risk urgent revascularization in chronic coronary syndrome patients.\[1\] The goal of this study is to assess whether the utility of using FFR during percutaneous coronary intervention (PCI) in chronic coronary syndrome patients is confirmed in a real-life scenario. This study will implement a regression discontinuity design (RDD). RDD is a quasi-experimental study design able to provide robust findings on causality using observational data.

All patients in this study were included in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), a sub-registry of SWEDEHEART. \[2\] Data regarding FFR assessments are documented in SCAAR in terms of FFR values and coronary segments investigated with FFR. The use of FFR during PCI is left at the discretion of the operator. Since a nondeterministic assignment to revascularization is expected at the cut-off, a fuzzy RDD design will be used in the analyses. Moreover, FFR values equal to 0.80 (at the cut-off) will be excluded from the analysis since treatment assignment exactly at the cut-off may substantially vary across operators and this may create distortions in the treatment discontinuity. Local linear regression estimates with Kernel triangulation and asymmetric bandwidth selection will be used in the analysis. Bandwidth selection will be based on a fully data-driven approach that minimizes the bias-variance trade-off.\[3\] Estimates from RDD will be presented as risk differences \[RD\] complemented by 95% robust confidence intervals.\[4\]

Eligibility Criteria:
Inclusion Criteria:

* Chronic coronary syndrome undergoing coronary angiography and FFR measurement
* Swedish personal identification number

Exclusion Criteria:

* previous coronary artery bypass grafting
* left main disease or undergoing FFR/PCI of left main
* IVUS/OCT use
* diffuse disease (≥ 2 segments treated in a same vessel investigated with FFR, ≥ 2 segments investigated with FFR in a same vessel)
* PCI in a distal segment with respect to FFR measurements
Effects of Sourdough Fermented Rye Crisp Bread on Appetite and Postprandial Metabolic Responses

The overall objective is to evaluate the impact of sourdough fermented crisp bread on effects on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite and postprandial insulin responses have been observed, particularly for unfermented rye crisp breads in a previous study. In the present study, the investigators evaluated how the intake of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well as a control refined wheat crisp bread product may affect self-rated appetite and postprandial insulin and glucose responses in healthy men and women in a meal-study. The investigators characterized intervention products with regards to microstructural and chemical features in order to elucidate underlying mechanisms for potential effects observed on appetite and postprandial metabolic responses.

Two commercial whole grain rye crisp breads processed differently (unfermented and sourdough fermented) and a refined wheat control product were tested in the study. The rye crisp bread products contained similar ingredients. All products provide similar amounts of available carbohydrates (about 30g). The total amount of test product is about 50-60g.

The specific primary aim of the study: To conduct a short-term breakfast intervention study in humans (n = 24) to compare the effect of 2 high-fiber rye crisp bread products processed in different ways (sourdough fermented or unfermented) and a refined wheat control crisp bread as part of a normal breakfast on self-rated appetite, postprandial glucose and insulin concentrations. Difference in post-prandial insulin response between products is the primary endpoint.

Secondary aim (conducted if significant effects in the primary endpoint have been demonstrated): To assess changes in hormones and their relation to self-perceived satiety, hunger and desire to eat and to differences in chemical and microstructural composition of the tested foods.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-30 kg/m2
* fasting plasma glucose \<6.0 mmol/L,
* fasting serum insulin \<11 mE/L
* serum TSH \<2.5 mIE/L
* plasma LDL \<5.3 mmol/L
* fasting plasma triglycerides (p-TG) \<1.8 mmol/L
* habitual consumption of breakfast, lunch and dinner

Exclusion Criteria:

* smokers
* use of medications likely to affect appetite
* medical conditions involving the gastrointestinal tract
* gluten intolerance or food allergies
* physical problems with eating
* dieting or self-reported fluctuations in body weight of more than 10% three months prior to screening recent participation in a dietary study
* pregnancy
* lactation
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* CD4 count \> 400/mm3.
* Eligibility for care in the military medical system.

Prior Medication:

Allowed:

* Acyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
* Evidence of AIDS dementia.
* Chronic hepatitis with severe liver dysfunction.
* Active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, or psychiatric disorder that would limit ability to complete the study.
* Hemophilia.
* Co-existent disease likely to result in death within the next 2 years.
* Known hypersensitivity to human interferon alpha.
* Known anaphylactic hypersensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin.

Concurrent Medication:

Excluded:

* Any other concurrent experimental medications.

Patients with the following prior conditions are excluded:

* History of AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
* Evidence of chronic hepatitis with severe liver dysfunction.

Prior Medication:

Excluded within 5 days prior to study entry:

* Immunosuppressive agents.
* Chemotherapy.
* Steroids.

Excluded within 45 days prior to study entry:

* BCG vaccine.
* Isoprinosine.
* Other immune modulators.

Excluded within 3 months prior to study entry:

* Any form of interferon.
* Antiviral therapy.
* Immunoregulatory therapy (other than acyclovir).

  1. Active drug abuse (narcotic or alcohol abuse documented within the past 6 months).
* Unlikely or unable to comply with the requirements of the protocol.
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia

To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
* The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
* The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:

  1. Risk factor (s) of infection
  2. Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
  3. Two or more positive sputum culture for Candida

Exclusion Criteria:

* Patient received any other antifungal drug within 1 month prior to enrollment.
* HIV positive patient
* Patients with organ transplant
* Patients with agranulocytosis
The Associations Between Dietary Choline, Genetics and Anxiety/Depression

The associations between dietary choline, genetics and anxiety/depression

Choline, previously considered to be a vitamin, is an essential nutrient involved in a plethora of biological pathways. Choline status is thought to be associated with depression and anxiety, however, the lack of evidence regarding the exact mechanism of its action warrants further investigation. This study aims to explore the associations between dietary choline and depression and anxiety in healthy individuals and how these may differ according to genetics, specifically Phosphatidylethanolamine N-Methyltransferase gene involved in endogenous and exogenous choline metabolism. Establishing these associations could reinforce the need for future intervention trials that could in turn establish causality and determine the mechanistic effects of dietary choline and the PEMT gene activity on depression/anxiety

Eligibility Criteria:
Inclusion Criteria:

* Overall healthy males
* pre-menopausal females of 18-50 years of age.

Exclusion Criteria:

* Individuals with a current clinical diagnosis of anxiety and depression
* pregnant or lactating
* post-menopausal women
* individuals suffering with chronic disease (cardiovascular disease, type-2 diabetes mellitus and cancer)
* individuals using choline, lecithin or soy supplements,
* obese individuals with a Body Mass Index (BMI) \>30 kg/m2.
Study of the Radio-clinical Correlation of Endolymphatic Hydrops

In patients presenting with symptoms of endolymphatic hydrops, signs of vestibular dilation are often found on MRI. Some patients present with these radiological signs without vestibular clinical signs, or signs other than those of hydrops. No study has yet investigated the radiological-clinical correlation of endolymphatic hydrops by selecting patients based on their imaging findings and then comparing them to the symptoms presented.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject (≥18 years)
* Subject presenting vestibular dilation on MRI

Exclusion Criteria:

* Subjects who have expressed opposition to the reuse of their data for scientific research purposes.
* Subjects under legal protection
* Subjects under guardianship or curatorship
Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC).

The secondary objectives were:

* To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);
* To assess the overall safety in both treatment arms;
* To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;
* to determine immunogenicity of IV aflibercept.

The study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. After disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first.

The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-confirmed prostate adenocarcinoma;
* Metastatic disease;
* Progressive disease while receiving hormonal therapy or after surgical castration;
* Effective castration.

Exclusion Criteria:

* Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed \>3 years ago;
* Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF receptor inhibitors;
* Eastern Cooperative Oncology Group (ECOG) performance status \>2.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.