cyrilzakka/clinical-trials huggingface dataset:
Treatment of Alopecia Using Follicular Stem Cells

Treatment of alopecia using the injections of cultured stem cells from human hair follicles,(which contain epithelial and mesenchymal cells stem cell)

The aim of the project is to develop a biomedical cell product based on and stem progenitor cells of the hair follicle and dermal papilla, to study its efficacy in the treatment of alopecia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of alopecia areata, androgenic alopecia and other non-scarring hair loss
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD

The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria:

* Medical diagnosis of asthma
* Chest X-ray diagnostic of significant disease other than COPD
* Significant condition or disease other than COPD
Evaluation of EarlySense for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment

The study objective is to collect data to assess the accuracy and reliability of Earlysense fertility cycle monitoring performance vs. acceptable known reference methods such as blood tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms.

The study objective is to assess the accuracy and reliability of Earlysense cycle monitoring to detect ovulation and implantation vs. acceptable known reference methods including blood tests and Ultrasound examination that are currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms that detect menses.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years ≤ 40 years
2. Healthy women with no significant background illness or Consenting women that arrive to IVF clinic for frozen embryo transfer on spontaneous cycle, or Consenting women that arrive for cycle evaluation or insemination on spontaneous cycle (infertile women).
3. Healthy women volunteers with regular menstrual cycles - not using contraceptives
4. Is willing to sign the consent form.
5. Sleeps on a mattress which allows placing a sensor under that mattress(so Earlysense sensor can be inserted under the mattress)
6. Regular cycle

Exclusion Criteria:

* Age \< 18 years or \> 40 years old
* Is not willing to sign the consent form.
* Does not sleep on a mattress that allows placing EarlySense sensor under it .(e.g., Futon0 Taking any significant medication or have major chronic diseases: e.g. Diabetes, CHF, COPD, Heart disease or pacemaker
* Taking pills (oral contraceptives or medical IUD w. progesterone)
* Women with irregular cycles (PCOS) or un-ovulation
Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence

Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot be explained by co-morbidity or anatomical and psychological changes of aging alone. In the nursing home population previous studies suggest a prevalence between 10 and 69%, but is most often reported to be between 40 and 55%. FI leads to a high direct and indirect economic burden to the health-care system, and is an important cause og institutionalization of the elderly patients. In addition, FI is associated with shame, social isolation and reduced quality of life.

The importance of identifying treatable causes of FI in the frail elderly, rather than just managing passively, is strongly emphasized. It is indicated that the level of awareness among health personnel regarding appropriate assessment and treatment options is limited, and that FI is considered a normal part of aging.

This study is based on the assumption that FI among nursing home patients can be prevented, cured or ameliorated by offering nursing home staff knowledge of best practise. The primary objective of the study is to test the hypothesis that a multifaceted educational program for staff on assessment and treatment of FI, is associated with a reduction in patients' frequency of FI.

The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated cross-sectional approach.The results will be analysed according to multilevel and longitudinal modelling, and the study will use mixed effect models with the cluster treated as a random effect.


Eligibility Criteria:
Inclusion Criteria:

Nursing homes with similar:

* patients characteristcs
* care staff/patients ratio
* general practitioner consultancy

Patients:

- All patients on long term care residency (residency \>month)

Registered Nurses/authorized social educators:

- All working half time or more

Exclusion Criteria:

Nursing homes:

- With some kind of speciality (eks rehabilitation, dementia)

Patients:

- Short term care residency

Registered nurses/authorized social educator:

* Working less than half time
* Working only night shifts
Natural History Study in Pediatric Patients With MYBPC3 Mutation-associated Cardiomyopathy

The objective of this study is to collect information on patients with cardiomyopathy (CM) due to mutations in the MYBPC3 gene, to evaluate their disease course, burden of illness, risk factors for this disease, and the quality of life (QoL). This study will also collect information on treatments, procedures and outcome in infants and children up to 18 yrs who have this mutation.


Eligibility Criteria:
Retrospective

Inclusion Criteria:

* Data is available for patient \<18 years of age. Patients must be \<18 years of age at enrollment or at time of death.
* Documented results of genotyping showing the presence of at least one pathogenic or likely pathogenic MYBPC3 mutation (heterozygous, homozygous, or compound heterozygous).

Exclusion Criteria:

* Patient received cardiac transplantation or died \>10 years before study initiation. For homozygous or biallelic infants, data may be collected beyond this 10-year period.

Prospective

Inclusion Criteria:

For Infants:

* Infants who are homozygous or compound heterozygous for the known pathogenic truncating MYBPC3 mutations are eligible.

For all other participants:

* Age \<18 at entry into the prospective study.
* Documented results of genotyping identifying at least one pathogenic or likely pathogenic MYBPC3 mutation (heterozygous, homozygous, or compound heterozygous).
* Diagnosis of Cardiomyopathy (CM): HCM, DCM, RCM, mixed CM, or LVNC.

Exclusion Criteria:

* Concurrent participation in an interventional clinical trial unless approved by the sponsor.
* Severe noncardiac disease anticipated to significantly reduce life expectancy.
Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.

Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18-70 years old
* Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
* Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
* Skin phototype 1-4

Exclusion Criteria:

* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* \> 10 cigarettes pr. day
* Participants not able to understand and read Swedish
* In investigator's opinion, participant is not able to follow instructions as specified in the protocol
* Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Diagnosed with reduced circulation
* Extensive skin changes, tattoos or diseases on probe application site
* Rejection by screening optical measurements
* Known allergy to medical grade alcohol
* Known allergy to adhesives
* Systemic or topical administration of glucocorticoids for the past 7 days
* Participants undergoing dialysis treatment
* Anti-coagulation or anti-platelet therapy
* Use of beta-blockers
* Medical conditions causing bleeding tendency
* Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to HIV and Hepatitis B or C.
* Participants currently enrolled in another study
Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure

The study aims to describe the clinical characteristics and clarify the predictors of the short- and long-term outcomes of RHF patients, further assist the diagnosis, risk stratification and treatment of RHF.

Right heart failure(RHF) is a clinical syndrome with symptoms, signs, and evidence of right ventricular systolic and/or diastolic dysfunction. For many years, it was largely neglected in the consideration of left-sided heart failure, while it is now evident that RHF is not only common but its presence also strongly contributes to increased morbidity and mortality. The in-hospital mortality of RHF is 7%, and the 30-day readmission rate is 20%. Therefore, diagnosis, potential treatment strategies, and prognosis improvement have become an unmet need in the field of cardiovascular disease.

In clinical practice, accurate diagnosis of RHF is the key to timely initiation of treatment and improvement of prognosis. Although current guidelines recommend clinical symptoms and signs combined with echocardiography, cardiac magnetic resonance, and other imaging means to evaluate right heart dysfunction for comprehensive diagnosis of right heart failure, the key diagnostic indicators included are inconsistent, the weight ratio of each indicator is different, the diagnostic threshold is not uniform, and the lack of comprehensive diagnostic model system brings great challenges to clinical practice.

This study aims to integrate multiple clinical biomarkers, imaging, and hemodynamic data to describe the clinical characteristics, establish noninvasive easy-to-use diagnosis models for right heart failure, and explore the risk factors for short- and long-term poor prognosis in patients with RHF.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years at the time of consent
2. Acceptation of right heart catheterization examination
3. Able to perform the entire protocol

Exclusion Criteria:

1. Life expectancy of less than 1 year based on the investigator's clinical judgment
2. Pregnant or nursing
3. Malignancy
4. Planned to undergo heart transplantation or device implantation
5. Acute coronary syndrome, uncontrolled severe arrhythmia and shock.
Comparison of Conventional and Cooled Radiofrequency Ablation in Knee Osteoarthritis

The aim of this study was to examine and compare the effects of conventional and cooled radiofrequency ablation on pain and disability levels in patients with knee pain resistant to other treatments due to knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Knee pain lasting more than 6 months
* Age between 50 and 80
* Diagnosis of radiographically proven grade III or IV knee osteoarthritis according to the Kellgren-Lawrence Grading Scale, marked narrowing of the medial compartment of the tibiofemoral joint space
* Presence of pain resistant to conservative treatment

  * Exercise
  * Physical therapy agents
  * Use of oral anti-inflammatory agents

Exclusion Criteria:

* History of trauma to the knee area
* History of knee surgery
* Presence of systemic inflammatory disease affecting the knee joint
* Presence of peripheral neuropathy or radiculopathy
* Pregnancy
* Hemodynamic instability
* Presence of skin or soft tissue infection at the injection site
* Refusal to participate in the study
* Presence of acute knee pain with accompanying inflammatory findings
* Presence of a serious psychiatric disorder or neurological disease Having received an intra-articular injection within the last 3 months
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

Although electronic cigarettes (e-cigs) are now widely used, very little information exists regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30 seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.

30 adult nonsmokers will have their cough reflex sensitivity measured at baseline, 15 minutes after an e-cig vaping session, and 24 hours subsequently. One e-cig vaping session will consist of 30 puffs of an e-cg (Blu) 30 seconds apart, which will deliver the approximate nicotine amount delivered by one tobacco cigarette. Cough reflex sensitivity, defined as C5, the concentration of capsaicin inducing 5 or more coughs, is the standard end point of cough challenge studies.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults (age18 years and above)
* nonsmokers

Exclusion Criteria:

* previous smoker
* asthma/other respiratory illness
* acute viral upper respiratory tract infection (common cold) in previous 4 weeks
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC

All participants received Best Supportive Care. Acronyms used in Adverse events section: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE), International Normalized Ratio (INR), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Cranial nerves (CN), Disseminated Intravascular Coagulation (DIC), Cardiac troponin T (cTnT).

Abbreviation used in Results section: Data Monitoring Committee (DMC). Adverse event collection will be covered in Adverse events section.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological documentation of adenocarcinoma of the colon or rectum
* Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
* Patients with measurable or non measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of \</= 1
* Life expectancy of at least 3 months
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Unstable/uncontrolled cardiac disease
* History of arterial or venous thrombotic or embolic events
* Symptomatic metastatic brain or meningeal tumors
* Patients with evidence or history of bleeding diathesis
* Interstitial lung disease - Persistent proteinuria \>/= grade 3
* Unresolved toxicity \> grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity \</= Grade 2
A Study of GZR18 Tablet in Chinese Healthy Subjects

The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects sign informed consent voluntarily.
2. Age 18-55 at screening (both included)，male or female（male only for part A）.
3. At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.
4. Female subjects were HCG negative at screening and baseline

Exclusion Criteria:

1. Female subjects who are pregnant or lactating at screening.
2. History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.
3. Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.
4. History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results.
5. Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.
Rotation Medical Bioinductive Implant Database Registry

The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive implant to treat rotator cuff tears.


Eligibility Criteria:
Inclusion Criteria:

1. At least 21 years of age.
2. Able and willing to provide voluntary consent to Registry participation.
3. Able to read, speak, and understand the English language.

Exclusion Criteria:

1. Hypersensitive to bovine-derived materials.
Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury.

Endoscopic technique has become an indispensable part of Natural orifice transluminal endoscopic surgery (NOTES). However, the upper gastrointestinal tract is easy to cause severe leakage complications, which mainly limits the application of endoscopy in rectum. Herein, investigators propose purse suture closing distal rectum and full-layer incision of the rectal wall using flexible endoscopic from anal to assist in hybrid transanal total mesorectal resection (taTME).Further reduce the damage of anus caused by taTME.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years old
2. Confirmed rectal adenocarcinoma cancer pathologically
3. tumor location ≦ 12 cm from the anal margin
4. Willing and able to provide written informed consent for participation in this study

Exclusion Criteria:

1. distant metastasis before surgery
2. more than one colorectal tumor at diagnosis
3. familial adenomatous polyposis
4. recurrent rectal cancer
5. undergo transanal minimally invasive surgery
6. undergo palliative treatment
7. undergo emergency surgery
Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)

This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will be ≥ 18 years old.
2. Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration.
3. MADRS score ≥ 20 at study entry.

Exclusion Criteria:

1. Participant is unable to give informed consent.
2. DSM-IV diagnosis of psychotic disorder (lifetime).
3. Bipolar disorder diagnosis and not on a mood stabiliser.
4. Eating disorder (current or within past year).
5. Obsessive compulsive disorder (lifetime).
6. Post-traumatic stress disorder (current or within past year).
7. Mental retardation.
8. Drug or alcohol abuse or dependence (preceding 3 months).
9. Inadequate response to ECT (current episode of depression).
10. Rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
11. Clinically defined neurological disorder or insult.
12. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
13. Pregnancy.
14. Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
15. Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
16. Participant becomes hypomanic or manic, as defined by DSM-IV.
Metabolic Phenotyping in Anorexia Nervosa

After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as lack of the patient's compliance and motivation to recover. However in studies, psychological relapse predictors explain only a minor part of the variance in relapse risk. Metabolic phenotyping has clinical value to predict weight course in obese patients and we assume that it could also be clinically relevant in patients with AN. We hypothesize that in patients with a dissipative but not with the thrifty phenotype, positive energy balance during refeeding causes an over proportional rise in energy expenditure, counteracts continuous weight gain during inpatient treatment, and increases relapse risk within one year after discharge. Thus we believe that metabolic phenotype as a biological parameter has prognostic value for the disease course in AN.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Anorexia Nervosa
* Between 12 and 18 years of age
* Written and informed consent of patient and parents
* Mental ability to understand the concept of the study
* Inpatient admission to Charité University Clinic with body weight below the 10th BMI-Percentile

Exclusion Criteria:

* Any further disease other than AN with significant influence on body composition and energy metabolism or its assessment