cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin

Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.

Herbal supplements such as Rubia cordifolia and Triphala \[a mix of Emblica officinalis (Amalaki), Terminalia bellerica (Bibhitaki), and Terminalia chebula (Haritaki)\] are commonly used for skin based treatments in India. However, the scientific evidence for their specific effects on the skin are scant. Rubia cordifolia is a root that is used in skin care for pigmentation and inflammation.1 Triphala is thought to have antioxidant properties and reduce inflammation in general. Herbs have been shown to modulate the gut microbiome, as previous studies have suggested that triphala may modify the gut microbiome.2

However, few studies have assessed the effects of these herbs from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.

Eligibility Criteria:
Inclusion Criteria for subjects:

1. Age 18 to 60 years of age
2. Subject must be able to read and comprehend study procedures and consent forms.

Exclusion Criteria for subjects:

1. Subject should be generally healthy and have no smoking history in the past one year.
2. Subjects must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
3. Those who are unable to discontinue topical medications for two weeks.
4. Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study.
5. Those who are unable to discontinue their Triphala and Rubia Cordifolia regimen for one month prior to starting study.
6. Subjects who are postmenopausal
7. Those who are pregnant or breastfeeding
8. Those that are prisoners or cognitively impaired
9. Those who have a known allergy to Rubia cordifolia, Emblica officinalis, Terminalia bellerica, Terminalia chebula.
The Effect of Lumbar and Sacroiliac Manipulation on Football Players

The purpose of this study was to assess the immediate effects of chiropractic spinal manipulation methods on the lumbar and sacroiliac regions on professional soccer players' flexibility and leaping abilities.

The study included 45 professional soccer players who were previously informed about the study and met the inclusion criteria. The 45 participants were then randomly divided into three groups: lumbar manipulation group (n=15), sacroiliac joint manipulation group (n=15) and control group (n=15).

The V-Sit Reach Test was used to assess flexibility, the vertical jump test (on the wall) was used to assess vertical jump, and horizontal jump was assessed with the help of a tape on the hall floor. Each test was repeated twice and the best result was recorded in centimeters (cm.). Five minutes after the initial tests were performed, the lumbar spinal manipulation group underwent lumbar spinal manipulation on the identified dysfunctional segment, the sacroiliac joint manipulation group underwent sacroiliac joint manipulation on the dysfunctional side, and the control group did not receive any treatment.

The same tests were then repeated without any waiting period and the best result was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Signing the voluntary consent form
* Being a male
* Being between ages of 18 - 35
* Playing professional soccer for a minimum of 6 months
* Asymptomatic dysfunction of the lumbar spine or sacroiliac joint.

Exclusion Criteria:

* Having an injury in the lower extremities
* Lumbar spine and sacroiliac region in the last 6 months
* Having a contraendication to the chiropractic treatments
Recovery and Analgesia After Surgery for Gynecological Cancer

The purpose of the study is to compare epidural analgesia and intrathecal analgesia for explorative laparotomy through a middle-line incision for gynecological cancer in a fast track program to se if there is any difference in recovery. Length of stay is analyzed together with self-rate quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Women with gynecological cancer (suspected or verified) planned for explorative laparotomy through a middle-line incision with a curative purpose.
* WHO performance status \< 2.
* American Society of Anesthesiologists class 1-2.
* Women that understand and can express themselves in Swedish.
* Women that after verbal and written information accept participation in the study and have signed an informed consent.

Exclusion Criteria:

* Women where surgery is expected to include part/s, other than the abdominal surgery, where intrathecal or epidural analgesia is not expected to be effective
* Women with contra indications for intrathecal or epidural anesthesia.
* Women who are physically disabled and therefore nor expected to be mobilized on the day after surgery in the same way as non-disabled.
* Women with a mental retardation that makes it impossible to fill in the relevant questionnaires or makes it impossible to understand the meaning of participation, or if it is ethically doubtful to include the woman.
* Women with psychiatric or mental disorder that according to the responsible physician makes it unsuitable to participate in the study .
Deworming Against Tuberculosis

The purpose of this study is to investigate whether treatment against intestinal helminths in patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical outcome by enhancing host immunity.

Mycobacterium tuberculosis causing tuberculosis (TB) is a major global public health problem. Because of increasing multi drug resistance and the long treatment period of at least six months, new therapeutic options are urgently needed. In countries like Ethiopia where TB is endemic, chronic worm infection is also highly prevalent. Recent data support that helminth infection might limit the host response against TB by inhibition of the TH1-response that is crucial in controlling the disease. In this study we want to test the hypothesis that Albendazole treatment of patients coinfected with helminths and TB could improve clinical outcome in addition to chemotherapy against TB. Additionally we will investigate the immunological interactions between TB and chronic helminths infection.

Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent to take part in the study
* Newly diagnosed pulmonary TB patients according to the WHO definitions of active tuberculosis who have a positive stool sample for helminths other than Schistosoma spp.

Exclusion Criteria:

* Pregnancy
* Corticosteroid or antibiotic treatment
* Symptomatic (diarrhoea) infection caused by worm infection
* Chronic diseases or acute infectious diseases other than TB or HIV
* Stool sample positive for Schistosoma spp
Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

Our study aims to prospectively compare outcomes of conservative treatment (occlusive dressing) to surgery with a palmar bipedicled island flap (modified Tranquilli-Leali flap) in the management of Allen zones II-III-IV fingertip injuries in long fingers. Based on these results, the investigators intend to help provide guidelines to optimize the management, and eventually the satisfaction of these patients.

The investigators intend to conduct a prospective tricentric (Hand Surgery Service in CHUV( Centre Hospitalier Universitaire Vaudois, Lausanne/ Hand Surgery Service in HUG (Hôpitaux Universitaire de Genève and Hand Surgery Service in Valais hospital, Sierre), open-label, randomized controlled trial: Occlusive dressing versus surgery in fingertips amputation.

The investigators will collect demographic data and informations about the injury including age, sex, medical history and daily medications, occupation, dominant hand, active smoking, mechanism of injury, associated injuries, time from injury to management, size and geometry (volar/transverse/dorsal) of defect, level of amputation (Allen classification), injury and repair of the nail bed.

Patients will be randomized into the occlusive dressing group or the surgical group on their first visit to the Hand Surgery department.

Both groups will have 6 months and 1-year follow-up appointment, including Ultrasound evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Allen zones II-III-IV long finger amputation.
* Trauma \< 48h.

Exclusion Criteria:

* Patients who are not able to give consent
* Injuries involving the DIP joint, extensor apparatus or requiring osteosynthesis.
* Chronic dermatological disorders of the hand, immunosuppressive drugs or chemotherapy. - Patient without a consent form would be excluded.
The Ideal Sequence of Hybrid Coronary Revascularization with Endoscopic Coronary Revascularization

Hybrid coronary revascularization (HCR), a combination of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), has emerged as an alternative treatment for multivessel coronary artery disease patients. However, the ideal sequence (PCI or CABG) is unclear.

The overall aim of this study is to investigate the best sequence within hybrid coronary revascularization using endoscopic coronary bypass grafting (i.e., first CABG then PCI versus first PCI then CABG)

Hybrid coronary revascularization (HCR) is an emerging approach for multivessel coronary artery disease (MVD) which combines the excellent long-term outcomes of surgery with the early recovery and reduced short-term complications of percutaneous coronary intervention (PCI). However, the best sequence within hybrid coronary revascularization remains unclear. When CABG is performed first (standard HCR), incomplete revascularization can cause acute coronary events in the interim period. On the other hand, when PCI is performed first (reverse HCR), bleeding risks may be higher since CABG should be performed on uninterrupted dual anti-platelet therapy (DAPT). The use of minimally invasive surgery techniques is associated with reduced bleeding because of the less surgical trauma and may offer the opportunity to perform reverse HCR due to the possibility to reduce the risk of bleeding.

The overall aim of this study is to investigate the best sequence within hybrid coronary revascularization using endoscopic coronary bypass grafting (i.e., first CABG then PCI versus first PCI then CABG, figure 1)

Eligibility Criteria:
Inclusion Criteria:

* Multivessel coronary disease, defined as ≥ 50% diameter stenosis by visual estimation in 2 or more of the three major epicardial vessels or major side branches, with at least one or more one stenosis amenable to revascularization with PCI, if the patient cannot be full revascularized by surgery for a specific reason as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis.
* Age 18-85
* Willing and able to provide informed, written consent

Exclusion Criteria:

* Requirement for other cardiac or non-cardiac surgical procedures (e.g., valve replacement, carotid revascularization)
* Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support at the time of randomisation
* Left main coronary artery disease
* Contraindication for dual antiplatelet therapy
* ST-Elevation Myocardial Infarction (STEMI)
* Previous cardiac surgery
* Participation in other interventional clinical trials
* Recent coronary intervention (PCI)
* Ongoing high risk non-ST-segment elevation acute coronary syndrome (ACS)
* Life expectancy \< 1 year
* Active bleeding more or equal to BARC 2 at time of randomisation
* Requiring renal replacement therapy
* Undergoing evaluation for organ transplantation
RIVET - Retrospective Cohort Study on the Risk of Venous Thromboembolism

The risk of venous thromboembolism (VTE) associated with the use of chlormadinone acetate (CMA) compared to the gold-standard progestin levonorgestrel (LNG) as component of combined oral contraceptives (COC) is currently unknown. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended a pooled analysis of four prospective cohort studies carried out by the Berlin Center for Epidemiology and Health Research (ZEG Berlin) in order to clarify whether CMA-containing COCs carry a different VTE risk compared to LNG-containing COCs.

This study is designed as a retrospective cohort study. ZEG Berlin conducted several large prospective cohort studies on the risk of VTE associated with the use of hormonal contraceptives. Four of these studies included a substantial number of women using CMA/EE or LNG/EE-containing COCs. For this study, the data on CMA/EE and LNG/EE from the following four prospective cohort studies are combined: 1) EURAS-OC/LASS 2) INAS-OC 3) INAS-SCORE and 4) INAS-FOCUS.

Participants will be identified retrospectively from a pooled dataset which comprises four large, controlled, prospective, non-interventional active surveillance studies that focused on the risk of VTE associated with the use of combined oral contraceptives. All data were prospectively collected by ZEG Berlin and follow the EURAS/INAS study design. Inclusion and exclusion criteria, the method of patient recruitment and follow-up as well as research methods were similar across studies.

The EURAS-OC/LASS study was conducted in Europe only; the other three studies are transatlantic studies that include subjects from both Europe and the United States of America.

This analysis is specifically designed to assess the risk of VTE associated with the use of COCs containing CMA/EE compared to LNG/EE.

Eligibility Criteria:
Inclusion: female, aged 15 to 49 years, participation in one of the 4 observational studies conducted between 2000 and 2019 (LASS/EURAS-OC, INAS-OC, INAS-SCORE, INAS-FOCUS), COC new user (starters, switchers, and re-starters), applied COCs: CMA/EE or LNG/EE.

Exclusion of women with a personal history of VTE.
Vitamin D Estimation With Giardia Lamblia Infections

investigators will take stool and blood samples from two groups of humans :-

1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections

In this research a case- control study will be used) ,the percentage of case to control will be 1:1 the total number of samples 192 ,investigators will take stool and blood samples from two groups of humans :-

1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections

Eligibility Criteria:
Inclusion Criteria:

* patient infected with Giardia lamblia.

Exclusion Criteria:

* patient takes vitamin D supplement - patient has kidney disease- patient has liver disease-patient has a debilitating disease disease such as cancer or diabetes.
CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab

The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age ≥18 years.
* Newly diagnosed with hepatocellular carcinoma
* Have measurable disease
* Have disease that responds to DEB-TACE
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Body weight \>30 kg
* Evidence of clinical or radiographic ascites with a score \< 7
* Patients must have adequate organ function defined by study-specified laboratory tests.
* Evidence of post-menopausal status or negative pregnancy test
* Willing and able to comply with study procedures
* Willing to undergo a liver biopsy

Exclusion Criteria:

* Anyone involved with the planning and/or conduct of the study.
* Has participated in another investigational study during the last 6 months.
* Any concurrent anticancer therapy or received therapy ≤30 days prior to study.
* Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of IP.
* Have a diffuse HCC (Hepatocellular Carcinoma), vascular invasion or extrahepatic tumor.
* Main portal vein thrombosis present on imaging.
* History of hepatic encephalopathy within past 12 months or require medications to prevent or control encephalopathy.
* Ascites within 6 weeks prior to study treatment.
* Any contraindications for embolization.
* Has an active infection such as TB, HIV, hepatitis B or C.
* History of another primary malignancy.
* History of leptomeningeal carcinomatosis.
* History of active primary immunodeficiency.
* Any unresolved toxicities from previous anticancer therapy.
* Grade ≥2 neuropathy.
* History of bleeding disorder.
* History or current use of immunosuppressive medications within 14 days prior to study medications.
* Has an active known or suspected autoimmune disease.
* Patients with hypothyroidism.
* Any active skin conditions.
* History of allogenic organ transplantation.
* Significant heart disease.
* Patients weighing \< 30 kg.
* Patients with celiac disease not controlled by diet alone.
* Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Have received a live vaccine within 30 days prior to study drug.
* Woman who are pregnant or breastfeeding.
* Known allergy or hypersensitivity to the study drug.
* Have received durvalumab, tremelimumab, anti-PD-1, anti-PD-L1 or anti-CTLA-4 in a prior study.
* Unwilling or unable to follow the study schedule for any reason.
A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis

This will be a phase I/IIa, open-label, three-stage, single center study aimed at investigating the safety, the efficacy (clinical and endoscopic effects) and the pharmacokinetics of Niclosamide enema 150 mg/60 ml and 450 mg/60 ml in subjects with mild-to-moderate UP and UPS, defined as a Modified Mayo Score (MMS) ≥ 4 and \< 8, with a stool frequency subscore (SFS) ≥ 1, a rectal bleeding sub-score (RBS) = 1 or 2, and an endoscopic subscore (mucosal appearance) = 1 or 2. At the endoscopic sub-score any degree of friability will be classified as having a sub-scale score of 2.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥ 18 years at the time of signing the informed consent;
2. Must understand and voluntarily sign an informed consent from (ICF) prior to any study-related assessments/procedures being conducted.
3. Must be able to adhere to the study visit schedule and other protocol requirements;
4. Diagnosis of UP or UPS with a duration of at least 3 months prior to the Screening Visit
5. MMS score ≥4 to \< 8 (range: 0-9) prior to enrolment in the study.
6. Availability to perform an endoscopy (colonoscopy or flexible rectosigmoidoscopy);

Exclusion Criteria:

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis;
2. UC extended more than 40 cm from the anal verge;
3. Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study;
4. History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, psychiatric, endocrine, hematological disorder or disease or any other medical condition that, in the Investigator's opinion, would preclude participation in the study;
5. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study;
6. Pregnant or breast feeding females;
7. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 4 weeks of screening;
8. Subjects who have received any investigational drug or device in the last 3 months;
9. History of alcohol, drug, or chemical abuse within the last 6 months;
10. Known hypersensitivity to niclosamide or any excipients in the formulation.
Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial

We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.

Subjects are randomly assigned at the time of stain-enhanced magnification colonoscopy to have any ACF removed or merely observed. Subjects are evenly divided into those with and those without a personal history of colon cancer. ACF are tabulated by an observer blinded to the subject's personal history. All subjects are then re-evaluated after one year by an observer blinded to the original procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Dept.of Defense Healthcare Beneficiaries
2. Age 18 or over, non-pregnant
3. History of colorectal cancer or other indication for colonoscopic screening
4. At least half of large intestine remaining
5. No use of investigational or chemotherapeutic drugs within 6 mos. -

Exclusion Criteria:

1. History suggesting familial colon cancer syndrome
2. \< 6 mos since colon resection or since treatment for colon cancer
3. Anticipated colon surgery within one year of entry
4. Inability to participate in scheduled followup at one year
5. Medical or psychiatric condition which would make patient a poor candidate -
Tiotropium / Respimat One-Year Study

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.


Eligibility Criteria:
TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure

This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2 gene and the risk of developing hyperglycemia during Intensive care unit stay


Eligibility Criteria:
Inclusion Criteria:

* admission in ICU\>48h
* at least one organ dysfunction

Exclusion Criteria:

* age\< 18 years
* pregnant women
* admission less than 48h