cyrilzakka/clinical-trials huggingface dataset:
Fibromyalgia: Impact of Self-Knowledge on Well-Being

The goal of this observational study is to evaluate the impact of self-knowledge training on the well-being of individuals with fibromyalgia. The main questions it aims to answer are:

Does self-knowledge training improve participants' perceived quality of life?

Does self-knowledge training influence the way participants manage their fibromyalgia symptoms?

Participants will:

Take part in a structured self-knowledge intervention based on the Enneagram framework.

Complete validated questionnaires before and after the intervention to assess their well-being.

Provide qualitative feedback on their experience with the training.

This study will help understand whether self-awareness strategies can be integrated into non-pharmacological approaches for fibromyalgia management.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia
* Age ≥ 18 years
* Ability to understand and provide informed consent

Exclusion Criteria:

* Cognitive impairment that prevents comprehension of the intervention
Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage

Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for the management of postpartum hemorrhage involve a stepwise approach including the exclusion of retained products and genital tract trauma. Uterine atony, which is the most common cause, is dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced to arrest the bleeding is the uterine tamponade using various balloons and catheters. The condom catheter uses a sterile rubber catheter fitted with a condom for uterine tamponade .

Objectives: To evaluate the outcome of uterine balloon tamponade using condom-catheter in the management of primary postpartum hemorrhage (PPH).

Material and Methods: Prospective observational study included 50 women with primary postpartum hemorrhage unresponsive to uterotonics and bimanual compression, was conducted at the department of Obstetrics \&Gynecology, Menoufia University Hospital, Egypt. Clinical assessment, laboratory investigations and intrauterine condom catheter were applied to all patients. The primary outcome was the success of the balloon to stop bleeding, maternal complications were assessed as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* women with primary postpartum hemorrhage ( defined as \>500 ml estimated blood loss after vaginal delivery or \>1000 ml after cesarean delivery)in the first 24 h , unresponsive to uterotonics and bimanual compression were enrolled

Exclusion Criteria:

* Patients with traumatic PPH, retained placenta, coagulopathy and severe systemic diseases were excluded from the study
Comparison Between 5-aminolevulinic Acid Photodynamic Therapy Versus Cryotherapy for Actinic Keratosis Treatment

This study aims to compare in a prospective and randomized way actinic keratosis treatment with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of therapeutic efficacy, pain, and cosmetic results.

Actinic keratosis is a skin lesion induced by chronic sun exposure with a significant prevalence and malignant potential for squamous cell carcinoma, which makes essential its treatment. Today there are several possible therapies, where cryotherapy is usually applied in our practice. Photodynamic therapy (PDT)is another method also widespread for keratosis which involves the administration of a topical precursor drug which produces endogenous photosensitising substances activated by specific light, selectively destroying the diseased tissue. This study aims to evaluate the use the drug formulation for photodynamic therapy 5-aminolevulinic acid (5-ALA) associated with dimethyl sulfoxide, comparing its efficacy with conventional cryotherapy, and also pain and cosmetic results. This project enrolled 137 outpatients from the Department of Cutaneous Oncology of Barretos Cancer Hospital - Pio XII Foundation, with symmetrical and comparable keratosis in their upper limbs. With the same patient as controls, side arm and therapy to be used were randomized: cryotherapy or photodynamic therapy. For cryotherapy was utilized bottles of liquid nitrogen (Cry-ac, 500ml); and for photodynamic therapy was utilized incoherent red light lamp with a total dosis of 37J/cm² . There was one or two sessions of each therapy , at 0 and 3 months; and three assessments for evaluation were done at 0, 3 and 6 months of onset. The evaluations on efficacy were in terms of area regression, and classified as complete response or no response. Pain was assessed by visual analogue scale, and numerical scale. Cosmesis was evaluated with the presence or not, objectively, of hyper, hypopigmentation or scar retraction. Finally, patient's preference regarding utilized therapeutics was noted by the researcher.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Patients with actinic keratoses "symmetrical", ie, comparable in the upper limbs ( with the same grade, I, II or III).
* Patients in accordance with informed consent.

Exclusion Criteria:

* Patients with concomitant skin diseases, congenital or acquired (albinism, vitiligo, xeroderma, Gorlin, etc.)
* Immunosuppression (HIV, transplanted patients, etc.)
* Pregnancy or lactation
* Patients who do not agree with the informed consent initially or during the protocol.
* Presence of pigmented lesions near the keratoses.
* Patients with porphyria.
* Patients who have undergone less than 2 months with some kind of treatment for keratosis in the upper limbs.
Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort

The purpose of this study was to study seasonal inter-individual and intra-individual variations in S-25(OH)D and to explore parameters associated with S-25-OHD in healthy Swedish adults.

Serum was collected during 12 months and analysed for 25(OH)D in 540 healthy blood donors. The blood donors answered questionnaires concerning vitamin D supplements, smoking, physical activity, sunbed use and holidays in sunny locations. Repeated serum samples were also collected from thrombocyte donors to study the intra-individual variations in S-25(OH)D.

Eligibility Criteria:
Inclusion Criteria:

* healthy at the time of donating blood

Exclusion Criteria:

* unhealthy
Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment

The purpose of this study is to better understand how effective ablation is for destroying tumor cells in the kidney and whether quality of life is improved for patients. Participation in ARMOR may involve retrospective data collection only, combined retrospective and prospective data collection, or prospective data collection


Eligibility Criteria:
Inclusion Criteria:

Retrospective enrollment:

- Patients having undergone percutaneous, open or laparoscopic energy ablation of a renal mass.

Prospective enrollment:

- Patients scheduled to undergo, rather than having undergone, percutaneous, open or laparoscopic energy ablation of a renal mass.

Exclusion Criteria:

* Patients not having undergone, or considered candidates for percutaneous, open or laparoscopic energy ablation of a renal mass
* Non-English speaking patients
* Patients under the age of 18.
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).


Eligibility Criteria:
Inclusion Criteria for Observation Phase:

* Voluntarily sign and date an informed consent agreement
* Have participated in and completed the double-blind study EN3835-201
* Be willing to apply sunscreen to any treated quadrant before each exposure to sun

Inclusion Criteria for Treatment Phase:

* Voluntarily sign and date an informed consent agreement
* Have participated in and completed the double-blind study EN3835-201
* Be willing to apply sunscreen to any treated quadrant before each exposure to sun
* Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13
* Be judged to be in good health
* Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal

Exclusion Criteria for Observation Phase:

* None

Exclusion Criteria for Treatment Phase:

* Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks
* Is presently nursing a baby or providing breast milk for a baby
* Intends to become pregnant during the study
* Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication
* History of stroke or bleeding
Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

In this study the safety and effectiveness of biosynthetic cornea, comprising interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested in patients with severe corneal pathology (corneal ulcers or corneal opacification from corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the only widely accepted treatment) carries a high risk of rejection.

Collagen-phosphorylcholine corneal substitute will be implanted in patient's corneas with severe pathology (corneal ulcer, corneal leukoma after burn, trauma or infection) using anterior lamellar keratoplasty technique, i.e. when patient's diseased cornea is removed it will be substituted with proposed transparent implant. Usually these patients are grafted with human donor cornea, but the latter frequently fails due to graft-versus-host problems. We will test the safety (incidence of adverse events, biocompatability) and the effectiveness (ability to promote healing and increase vision) of developed biosynthetic corneas in 10 patients with corneal pathology, where human donor cornea carries a high risk of rejection. The patients will be follow-uped for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must sign and be given a copy of the written Informed Consent form.
2. Subjects with best corrected distance visual acuity 20/200 or worse as a result of corneal ulcer or corneal scar due to burn, injury or infection in the operative eye.
3. Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

Exclusion Criteria:

1. Subjects with severe or life-threatening systemic disease.
2. Subjects with uncontrolled hypertension.
3. Subjects with uncontrolled diabetes or insulin-dependent diabetes.
4. Subjects with glaucoma in either eye.
5. Subjects with marked microphthalmos or aniridia in either eye.
6. Subjects with any other serious ocular pathology, serious ocular complications at the time of corneal transplant underlying serious medical conditions, based on the investigator's medical judgment.
7. Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.
Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients

To investigate the effects of total knee replacement is harmful to Postoperative cognitive dysfunction

Postoperative cognitive dysfunction (POCD) is reported to occur after major surgery in elderly patients. They may especially experience problems in the weeks and months after surgery. Recent studies vary greatly in methods of evaluation and diagnosis of POCD, and the pathogenic mechanisms are still unclear. The investigators evaluated a large uniform cohort of elderly patients in a standardized approach after total knee replacement.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥65 years;
* ASA I or Ⅱ;
* total knee replacement

Exclusion Criteria:

* Mini Mental State Examination \[MMSE\] score too low.
* Parkinson or other neurological disease causing functional impairment.
* Patients with a history of alcohol abuse (≥35 U per week) or daily use of anxiolytics were also excluded, as well as those with severe hearing or visual impairment.
Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years;
* Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus;
* Child-Pugh A or B (7 score) liver function;
* With more than 3 months expected survival;
* The volume of residual liver more than 30%;
* Patients agree to take part in.

Exclusion Criteria:

* Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus
* Previous history of epigastric radiotherapy
* With extrahepatic metastasis
* With radiotherapy contraindication;
* Pregnant woman or sucking period;
* With repture tumor;
* With other cancer in previous five years;
* With chemothrapy, target therapy or immunosuppressive drugs therapy.
Comparison of Exercise Therapy Vs Mobilization With Movement Among Patients With Knee Osteoarthritis

Comparison of exercise therapy Vs mobilization with movement among patients with knee osteoarthritis in household females

To determine the effect of exercise therapy and mulligan\*s mobilization with movement techniques on pain and difficulty in performing ADLs with knee OA in household females.

Eligibility Criteria:
Inclusion Criteria:

* Subject with age group of 40-60 included in this study.
* History of knee osteoarthritis, with grade I or II.
* No impairment in other body parts.
* Patients already diagnosed with osteoarthritis by orthopedic surgeon.

Exclusion Criteria:

* Patients with communication problems
* Patients with a history of previous stroke or other neurological diseases or disorders.
* Patients with inflammation.
* Patients who had undergone any surgery.
* Infection or dermatological conditions.
* cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction etc).
Valsalva Maneuver in Thyroidectomy

Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient.

Between January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre.

The purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* thyroid diseases

Exclusion Criteria:

* lymph node dissection
* minimally invasive approaches
* high anesthesiological risk
Tenelia Elderly CGMS Study(TEDDY)

To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 65 years or older on screening
* Patients with type 2 diabetes mellitus
* Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit
* Patients with FPG \< 270mg/dL on screening visit

Exclusion Criteria:

-
Effect of Oral Feeding in Infants With Pierre Robin Syndrome

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Pierre Robin Syndrome (PRS) can cause dysphagia. In China, persistent nasogastric tube feeding (PNG) is the mainstream choice as nutrition support in the dysphagic infants with PRS. However, PNG is associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. Therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (IOE) compared to PNG in the dysphagic infants with PRS who received systemic therapy.

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with IOE) and the PNG group (with PNG), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria for Pierre Robin sequence based on CT and X-ray examinations, combined with clinical manifestations and physical signs.
* with spontaneous vaginal birth, aged 1 to 12 months.
* with dysphagia.
* before the treatment, the tube feeding was required and feasible after evaluation.
* stable vital signs.
* with nasogastric tubes placed before the treatment.
* sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device).

Exclusion Criteria:

* abnormalities in brain development or other neurological lesions revealed by CT or MRI scans.
* dysphagia caused by other diseases.
* other congenital malformations, such as Down syndrome, cleft lip, and palate, etc.
* severe systemic disease (such as severe infection, severe hepatic and renal dysfunction).
* participants who need to receive other therapy which would potentially affect the result of this study
Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Children

A health education learning package (HELP) has been improved and evaluated for its impact against intestinal parasitic infections among Orang Asli schoolchildren in West Malaysia. 13 schools were allocated into two groups (intervention and control groups) and the impact of HELP was evaluated after 3 and 6 months of baseline assessment and HELP intervention.

This study was conducted to evaluate the impact of an improved health education learning package (HELP) against intestinal parasitic infections among Orang Asli schoolchildren in West Malaysia. The package has been tested by a pilot study in 2013 among children in 2 schools in Pahang state.

In the current study, HELP package has been improved and children from 13 primary schools in 11 districts of six states in Peninsular Malaysia were allocated into two groups (intervention and control groups) and the impact of HELP was evaluated after 3 and 6 months of baseline assessment and HELP intervention.

The evaluation involved soil-transmitted helminth infections and intestinal protozoa infections.

Eligibility Criteria:
Inclusion Criteria:

* Grade 2 - 6
* Orang Asli ethnicity
* Schools exclusively for Orang Asli

Exclusion Criteria:

* Grade 1
* Chronic sever diseases
* no consent
* schools for mixed population groups
The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT

Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI are widely treated with Continuous renal replacement therapy (CRRT). However, previous studies have hardly documented improvement of mortality in septic AKI patients. Otherwise, Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be related to the outcome of septic AKI patients who undergo CRRT. In this study, the investigators measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound for experimental group, while for control group, fluid status would be determined clinically by the physician. Ultrafiltration rate of experimental group is adjusted to be equal to the value of overhydration measured by BIA.


Eligibility Criteria:
Inclusion Criteria:

1. body temperature \< 36 °C or \> 38 °C
2. heart rate \> 90 BPM
3. respiratory rate \> 20 or aPaCO2 \< 32 mmHg on ABG
4. White blood cell count \< 4,000 cells/mm3 or \> 12,000 cells/mm3 or band forms (immature white blood cells) ≥10%
5. Evidence of infection
6. WBCs in normally sterile fluid
7. Perforated viscus
8. radiologically proven infection
9. more than Injury stage in AKI according to RIFLE criteria
10. septic AKI which is not explained by other cause
11. patients signed a written informed consent.

Exclusion Criteria:

1. Younger than 19 years old, older than 80 years old
2. Previously undergoing dialysis treatment due to ESRD
3. Underlying malignancy, Life expectancy shorter than 3 month
4. AKI due to other than sepsis
5. patients with intracardiac device such as Pacemaker, CRT, ICD