cyrilzakka/clinical-trials huggingface dataset:
Exosomes for Hairloss Treatment

Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. This study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are able to read documents and can sign informed consent.
2. 18\~75 years old (including the threshold), gender is not limited.
3. The subject's "hair loss grade" meets the following criteria:

1) BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or special type (V1 to V3, or F1 to F3); 2) For female: Ludwig Grade I to II. Or for male: Hamilton-Norwood Grade III to IV; 3) Hair density by phototrichogram: ≤ 190 hair/cm² ; 4. Hair dryness ≥ 5%; 5. Until withdrawal/completion of the study, subjects agree not to undergo any topical treatment for hair loss and agree to use a neutral shampoo.

Exclusion Criteria:

1. People with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss.
2. Those with a combination of diseases that have an impact on hair growth.
3. Use of medications, medicated shampoos, or hair care products that may interfere with efficacy evaluation within 3 months prior to screening (oral administration of therapeutic agents for androgenetic alopecia must be discontinued for at least 6 months).
4. Have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening.
5. Participated or are participating in a interventional clinical trial within 3 months.
6. Persons with a history of hereditary alopecia areata.
7. Women who are pregnant or breastfeeding, or male/female subjects whose own/partner's pregnancy is planned within 6 months.
8. Have undergone hair transplantation in the previous 24 months.
9. Individuals testing positive for active infectious diseases or carriers of communicable pathogens.
10. Those with keloid, keloid-prone or hyperplastic scarring.
11. Those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.
Effectiveness of Manual Therapy and Neuromuscular Training in the Management of Knee Osteoarthritis

The purpose of the study is to compare the short-term effectiveness of manual therapy with neuromuscular training and conventional physical therapy with neuromuscular training in patients with knee osteoarthritis.

Knee osteoarthritis (OA) is a major public health problem, characterized by progressive degeneration and loss of articular cartilage, resulting in pain, limitation of movement, imbalance, functional disability, and diminished patient quality of life. Regular participation in physical activity has been recognized for several years as being beneficial in the management of knee OA. The role and effectiveness of manual therapy techniques and conventional physical therapy are evident from the existing literature, but no comparison was found for the combination of neuromuscular training (NMT) in patients with knee OA. Thus, the aim of this study is to compare the short-term effectiveness of manual therapy (MT) versus conventional physical therapy (CPT) with NMT in the management of knee OA after six weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Complaining of knee pain that has lasted longer than 3 months.
* Pain level that is medium (pain score greater than or equal to 4).
* No knee injuries.
* Treatment not received in another physical therapy clinic in the past three months.
* Painful range of motion in the knee.

Exclusion Criteria:

* History of knee surgery
* A systemic arthritic condition
* Any other muscular, joint, or neurological condition affecting lower limb function.
* Received physical therapy or an intra-articular injection in the knee within the past 3 months.
Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates

The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively.

To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.


Eligibility Criteria:
Inclusion Criteria:

* •Qmax \< 12 mL/s, IPSS \>19

  * Age between 50 and 70 years
  * Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure.

Exclusion Criteria:

* •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery
RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation

Poor graft function (PGF) after allogeneic hematopoietic cell transplantation (allo-HCT) is a misunderstood complication associated with poor outcome and limited therapeutic options. Despite the lack of standardized diagnostic criteria, PGF is commonly defined as follows: one or several significant cytopenias after allo-HCT persisting or developing after allo-HCT despite full donor chimerism and in the absence of relapse or other causes. Not only PGF can alter patients' quality of life by leading to recurrent transfusions, bleeding events and infections, but it is also associated with poor survival after allo-HCT.

Although PGF is relatively frequent, there is no well-codified behavior in the literature or in the recommendations issued by the various learned societies of transplantation.

The aim objective of the investigator's study is to demonstrate that eltrombopag improve PGF after allo-HCT


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of poor graft function defined as:

  * Patient ≥ day+60 after allo-HCT,
  * Persisting thrombocytopenia on two different samples over at least two weeks (platelet \< 30G/L with transfusion requirement) +/- neutropenia (ANC \<1G/L) +/- anemia (Hb \<8g/dL or transfusion requirement),
  * Full donor chimerism on whole blood (≥ 95%),
  * Biopsy proven hypocellular marrow without evidence of myelodysplasia
  * No evidence for relapse,
  * No evidence for active acute or chronic graft versus host disease,
  * Absence of active viral infection (EBV, CMV, ADENOVIRUS, PARVOVIRUS B19),
  * Absence of B9/B12 deficiency,
  * Absence of hypothyroidism,
  * Absence of hypogonadism,
  * Absence of dialysis,
  * Absence of thrombotic microangiopathy,
  * Absence of macrophage activation syndrome,
  * No other known causes of poor graft function.
* Written informed consent must be obtained before any study-trial specific procedure are performed,
* Affiliation to a social security system.

Exclusion Criteria:

* Criteria for poor graft function not fulfilled (see above),
* Patients aged less than 6 years old (or unable to swallow),
* Hepatic impairment (Child-Pugh ≥ 5),
* Patients with bone morrow fibrosis,
* Patients with a cytogenetic abnormality of chromosome 7
* Hypersensitivity to eltrombopag or to any of the excipients,
* Patients with any contra-indication to eltrombopag, filgrastim,
* Unable to understand the investigational nature of the study or give informed consent,
* History of congestive heart failure, arrhythmia requiring chronic treatment, arterial or venous,
* Thrombosis (not excluding line thrombosis) within the last 1 year, or myocardial infarction within 3 months before enrollment,
* ECOG Performance Status of 3 or greater,
* Pregnant and/or lactating women,
* Freedom privacy.
Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment

A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function.

Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.

Eligibility Criteria:
Inclusion Criteria:

All subjects:

* Males or females, 18 to 75 years old
* Willing and able to give written informed consent

Patients with hepatic impairment:

* Mild hepatic impairment (Child-Pugh A \[5-6 points\])
* Moderate hepatic impairment (Child-Pugh B \[7-9 points\])
* Severe hepatic impairment (Child-Pugh C \[10-15 points\])

Healthy subjects:

* Match in age, gender and body mass index with hepatic impaired subjects
* Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history

Exclusion Criteria:

All subjects:

* Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half-lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device)
* Any signs or symptoms of acute illness at screening or Day -1
* History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease

Patients with hepatic impairment:

* History of liver transplantation, hepatic mass suggestive of hepatocellular carcinoma or acute liver disease
* Screening serum ALT or AST \>5 times the upper limit of normal
Blood Loss Quantification During Major Abdominal Surgery

Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for liver or pancreatic surgery
* age of patient ≥ 18 years
* signed informed consent provided

Exclusion Criteria:

* patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants).
* use of cell saver suctioning during operation
* damage/clotting of blood samples
Healthy Diet for Healthy Moms and Babies

The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the development of gestational diabetes, maternal glucose and lipid control and inflammation in obese pregnant women at risk of developing diabetes. With the ongoing epidemic of obesity, the prevalence of gestational diabetes is significantly increasing and the goal of this research is to identify optimal dietary strategies that can reverse this condition or control the rise in blood glucose among those with already developed diabetes.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> or = 30, \<20 weeks gestation and singleton pregnancy with the following options: previous history of gestational diabetes and/or family history of diabetes

Exclusion Criteria:

* • Twin or multiple pregnancy

  * Chronic pre-pregnancy conditions (CHD, cancer, diabetes)
  * Gastrointestinal conditions
  * Anemia
  * Allergic to berries and fiber
  * Vegetarian food habits or special diets
  * Not proficient in English and/or unable to provide consent
Injectable Platelet Rich Fibrin in Periodontal Treatment

The aim of this randomized controlled parallel clinical trial is to investigate the efficacy of injectable Platelet Rich Fibrin (iPRF) as an adjunctive to non-surgical periodontal therapy (STEP 1 \& 2 of periodontal treatment).

Thirty-two (32) patients diagnosed with stage III periodontitis will be randomly assigned to two study groups. Participants will receive non-surgical periodontal treatment only (control group) or non-surgical periodontal treatment with iPRF (test group). Patients will receive step 1 and 2 of periodontal treatment. Step 2 of periodontal treatment will be completed in one visit. Test group also will receive immediately after the subgingival instrumentation iPRF at the sites with PPD≥5mm.

Subgingival plaque will be collected with paper points at different time points- baseline: before treatment, 3 and 6 months after treatment.

The presence and quantification of bacteria: -Porphyromonas gingivalis (Pg), Filifactor Alocis (F.Alocis)- will be examined with quantitative polymerase chain reaction (q PCR). Clinical parameters, including bleeding on probing (BOP), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (REC) will be recorded at baseline, 3 and 6 months after treatment.

Patient satisfaction will be assessed through questionnaires regarding quality of life, pain perception and the use of analgesics. The questionnaires will be completed one week after subgingival instrumentation.


Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: \>18 years old (Adults)
* Diagnosed Periodontitis Stage III
* Presence of ≥ 15 teeth
* Signed written consent form by patient

Exclusion Criteria:

* At least one edentulous jaw
* Need for chemoprophylaxis before treatment
* Periodontal treatment the last 6 months
* Antibiotic treatment the last 6 months
* Immunomodulatory diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis), for which patients do not take medication
* HbA1c\> 7.0% in patients with diabetes
* Pregnancy/ Lactation
* Medications or undergoing treatment which may affect mucosal healing
Cannabinoids, Neural Synchrony, and Information Processing

The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 and 55 years (extremes included) on the day of the first dosing.
* Exposed to cannabis at least once.

Exclusion Criteria:

1. Cannabis naïve
2. Positive pregnancy screen during screening
3. Hearing deficits
Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM

The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.

The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.

The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.

Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>/= 35

Exclusion Criteria:

* need for crash induction.
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.

REDuCe is designed to evaluate the role of ROTEM™ in determining the need and the amount of pre-emptive blood products use in patients with cirrhosis undergoing elective procedures compared to the current standard of care. The secondary aim of this study is to evaluate ROTEM™ parameters in patients with acute decompensation, acute on chronic liver failure and acute liver failure and to co-relate it with the conventional coagulation tests.

Patients with cirrhosis who meets eligibility criteria will be divided into two groups

1. Those who are undergoing elective procedures will be randomized into 1:1 ratio into either standard of care (institutional transfusion protocol) or ROTEM guided protocol. Baseline ROTEM will be obtained before and after blood product transfusion.
2. Those who are not for elective procedures and does not meet criteria for randomization will be entered into data collection for secondary endpoints analysis. These patients will have baseline ROTEM before transfusion and post transfusion ROTEM in those who require blood prodducts transfusion.

Eligibility Criteria:
Inclusion Criteria:

Patients with Cirrhosis undergoing elective procedure must meet all following criterias.

1. Patients undergoing the following elective procedures will be included in the study

   1. Gastroscopy with endoscopic variceal ligation
   2. Colonoscopy with polypectomy and endoscopic mucosal resection
   3. ERCP with sphincterotomy
   4. Percutaneous liver biopsy
   5. Biopsy of other sites (excluding liver)
   6. Hepatic venous pressure gradient with or without liver biopsy
   7. Elective Transjugular Intrahepatic Portosystemic Shunt
   8. Portal Vein embolization
   9. Trans-arterial chemo-embolization (TACE)
   10. Thermal ablation of hepatocellular carcinoma
   11. Large volume paracentesis
   12. Central venous catheter insertion
   13. Thoracentesis
2. Age: Older than 21 years
3. Coagulopathy based on conventional coagulation tests which is defined as

   1. INR \> 1.5 and/or aPTT \> 1.5x ULN for PTT and/or
   2. Platelets \< 50,000/mm3/uL
4. Patients with acute decompensation, acute on chronic liver failure and acute liver failure.
5. Able to give informed consent.

Exclusion Criteria:

1. Emergency procedures. (defined as life-saving procedures)
2. On-going bleeding
3. Under 21 years of age
4. Inability to obtain informed consent from patients
5. Coagulation disorders (other than those relating to liver disease)
6. Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixaban, heparin, clexane etc.)
7. Patients on anti-platelet aggregation agents other than aspirin (e.g. clopidogrel, ticagrelor)
8. Active malignancy except hepatocellular carcinoma
9. Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days
10. Patients with stage 4 or 5 chronic kidney disease
11. Patients receiving renal replacement therapy
12. Patients with active sepsis as defined by ACPP-SCCM criteria (21).
13. Pregnant Women
Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis

To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-75 years.
* Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies.
* At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
* HDSS score of 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4.
* Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment .

Exclusion Criteria:

* Dermal disorder including infection at anticipated treatment sites in either axilla.
* Previous botulinum toxin treatment of the axilla in the past year.
* Expected use of botulinum toxin for the treatment of any other disease during the study period.
* Known allergy to starch powder, iodine, lidocaine, or epinephrine.
* Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria.
* Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.

This study seeks to (1) compare the changes in 6-minute walk distance (6MWD) and physical function quality of life in patients with peripheral artery disease (PAD) following a combined intervention of the dietary approaches to stop hypertension (DASH) dietary program plus a home-based exercise program, and following a home-based exercise program alone; and (2) compare the changes in microvascular function and inflammation in patients following the combined DASH diet and home-based exercise program, and the home-based exercise program alone.

The investigators hypothesize that the combined DASH diet and exercise program will result in greater increases in 6MWD and in the physical function quality of life than the exercise program alone. Further, it is hypothesized that the combined DASH diet and exercise program will result in greater improvements in calf muscle oxygen saturation \[StO2\] following exercise, and in high-sensitivity C-reactive protein (hsCRP\]) than the exercise program alone.

The home-based exercise program consists of intermittent walking to moderate claudication pain in a home-based setting. The DASH dietary program consists of the dietary approaches to stop hypertension diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy.

Eligibility Criteria:
Inclusion Criteria:

1. History of claudication,
2. Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \< 0.90, or \> 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (\> 0.90), or history of peripheral revascularization.

Exclusion Criteria:

1. absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \> 0.90), \< 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,
2. non-compressible vessels (ABI \> 1.40),
3. rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
4. tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
5. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
6. peripheral revascularization within one month prior to investigation,
7. active cancer,
8. end stage renal disease defined as stage 5 chronic kidney disease,
9. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
10. cognitive dysfunction (mini-mental state examination score \< 24), and
11. failure to complete the baseline tests within three weeks.